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Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence (2008)

Chapter: 4 Evidence and Conclusions: Psychotherapy

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Suggested Citation:"4 Evidence and Conclusions: Psychotherapy." Institute of Medicine. 2008. Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11955.
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4 Evidence and Conclusions: Psychotherapy P sychotherapeutic interventions for posttraumatic stress disorder (PTSD) vary in their emphasis on reexposure to trauma-related memories and stimuli, cognitive restructuring of the trauma experience, expression and management of emotion, training in stress management (including relaxation training), and general social and vocational support. Although a number of these treatments emphasize one of these components, many combine more than one either implicitly or by design, and relatively few studies dismantled effective components of the psychotherapy. A more com- plete description of psychotherapy is provided in Appendix A. The committee noted that virtually all of the recent literature on psycho­ therapies for PTSD examines interventions that some experts consider com- ponents of cognitive-behavioral therapy (CBT). For example, Harvey et al. (2003) describe four basic components of CBT: psychoeducation, exposure, cognitive restructuring, and anxiety management training. The theoretical literature also acknowledges the overlap among these approaches as well as incomplete understanding of the mechanisms at work when these inter- ventions are used (Foa and Meadows, 1997; Foa et al., 2000; Harvey et al., 2003). Nonetheless, the committee found that the psychotherapeutic approaches studied in the literature are segmented into CBT components alone and in various combinations. In presenting the summaries below, the committee has grouped therapies based on its understanding of the psycho­ therapeutic literature and for convenience of exposition, but is aware that others have and may organize the literature differently. The committee identified the following categories of psychotherapies (as used in a treat- ment condition or “arm”): exposure, cognitive restructuring, coping skills 93

94 TREATMENT OF POSTTRAUMATIC STRESS DISORDER training, exposure plus cognitive restructuring, exposure plus coping skills, eye movement desensitization and reprocessing (EMDR), other psycho- therapies, and group format psychotherapy. Exposure refers to several closely related techniques such as prolonged exposure, direct exposure therapy, and multiple channel exposure therapy, and they are evaluated here as one category, both alone and in combination with other approaches. The category of coping skills training includes stress inoculation therapy, relaxation, biofeedback, and so on. The category of cognitive restructuring refers to psychotherapies designed to help individuals with PTSD alter their understanding of the meaning of their traumatic experiences, for example, by considering their adaptive responses to the trauma as well as the help- lessness inflicted by it. The treatment modalities assessed in this chapter were individually administered with a few exceptions where psychotherapy was administered in a group format. The majority of psychotherapy studies compared one or more active treatments to a wait-list control. Less frequently, the control was usual care (such as non-PTSD specific care) or minimum care (such as phone counsel- ing). A smaller proportion of the psychotherapy studies compared active treatment to an active control such as a coping skills training program (e.g., relaxation) or present-centered therapy. The committee included 52 studies of psychotherapies (reasons for exclusion are listed in the individual sections below). Of the included s ­ tudies, 18 had no major limitations and thus were most informative to the committee’s conclusions regarding efficacy of a treatment modality (see evi- dence tables following each treatment for a summary of these studies), but such studies were considered in the context of the body of evidence for each treatment modality. Trauma types in these studies included combat (within the United States and internationally), sexual abuse, physical assault, ac- cidental injury, motor vehicle accidents (MVAs), natural disaster, witnessing (death or genocide), being a victim of crime, and being a refugee. When analyzing the studies by sex, population, or trauma type, the committee labeled the study as being “predominantly” one type of sex, population, or trauma if 80 percent of the study population or more was of one type of sex, population, or trauma. The committee labeled the study as “mixed” if 79 percent or less of the study population was of one type of sex, population, or trauma. Eleven studies had a predominantly male population, 25 had a female population, and 15 had a mixed (male and female) population. Ten studies were in veteran populations, 17 in- cluded victims of sexual or physical abuse, and 23 had a mixed or other trauma type. The committee found that in the psychotherapy literature, as in the pharmaco­therapy literature, with few exceptions, when a veteran   Some studies did not include sex or trauma type.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 95 p ­ opulation predominated, the participants were mostly male, and when the majority of cases had been sexually abused or assaulted, participants were mostly female although there are instances when that is not the case. With mixed trauma type, the sex ratios were more equally divided. EXPOSURE THERAPIES The committee found a substantial number of randomized controlled trials (RCTs) comparing exposure therapies (alone or with some other component) to wait-list or usual care controls. The category of exposure comprised exposure therapies alone and several different combinations of exposure with cognitive restructuring or coping skills training. The large number of studies of exposure therapy comprises the range of features found in the rest of the psychotherapy studies, with regard to length of treatment, variety of trauma, age of participants, training of clinicians, and so on. Participants in the exposure therapy studies had suffered a variety of traumas, including combat-related, sexual abuse and/or assault, civil war, and motor vehicle accident. The mean age of study participants ranged from early-20s to the 50s, with most studies reporting a mean age between the mid-30s and mid-40s. Few studies reported duration of illness, but many provided information about the time since trauma, which ranged from several months in studies with rape survivors to more than two d ­ ecades in studies with veterans. Some studies, such as those in survivors of sexual assault, included only female participants, while many others had a mix of men and women, and studies in people traumatized by combat had all male participants. Some, but not all, studies provided information about the race/ethnicity of participants. In most studies, participants were white, with a smaller number of studies reporting percentages of non-white participants at approximately 20 percent, 30 percent, and in a few cases, nearly 50 percent. Exposure therapy included psychoeducation, breathing retraining, and relaxa­tion, in addition to exposure (specifically imaginal and in vivo expo- sure, flooding, directed therapeutic exposure, etc.). Some exposure therapy programs also required completing homework, generally repeated exposure to a trauma tape or other record of the trauma narrative. Exposure ­studies, like other psychotherapy studies, are lengthy and require considerable invest­ment of time, emotion, and effort. Most studies administered expo- sure and usually also the comparison treatments for at least several weeks (e.g., 4.5, 9–12, 30 weeks). Only a small number of studies provided treat- ment in one session or for a short time: one 60-minute session in Basoglu et al. (2005), one session in Basoglu et al. (2007), two 90-minute sessions in Boudewyns et al. (1993).

96 TREATMENT OF POSTTRAUMATIC STRESS DISORDER Most studies reported that study therapists had at least master’s level training and frequently held doctorates in psychology, clinical ­psychology, or clinical social work. Only one study used therapists with less then gradu- ate training but considerable counseling experience, and a few studies used graduate students. Most studies used psychologists, but several studies also used marriage and family counselors (MFCCs), licensed clinical social workers, and one study also used nurses. The majority of studies reported that study therapists were trained and supervised. The majority of exposure therapy studies did not report on or measure adverse events associated with their treatment condition. Only Monson et al. (2006), Foa et al. (2005), Schnurr et al. (2007), and Chard (2005) measured adverse events. Many studies conducted follow-up after the completion of treatment. The earliest timing of follow-up assessments was 1 month, and the latest was between 1 and 2 years after treatment. Some studies took follow-up measures at 3, 6, and 9 months post-treatment. Of the 23 studies in this category, 16 had major limitations including high dropout rates, absent or weak treatment of missing values, lack of assessor independence, not conducting an intention to treat analysis, or failure to report a critical characteristic (Blanchard and Hickling, 2004; Boudewyns et al., 1993; Classen et al., 2001; Cloitre et al., 2002; Falsetti et al., 2001; Foa et al., 1991, 1999, 2005; Glynn et al., 1999; Keane et al., 1998; Kubany et al., 2003, 2004; McDonagh et al., 2005; Power et al., 2002; Resick et al., 2002; Rothbaum et al., 2005). Eight studies met most or all of the quality criteria outlined in Chapter 2 (the main shortcoming in two of these studies was in the handling of substantial dropout rates with less robust statistical methods and or assessor blinding or independence) (Basoglu et al., 2005, 2007; Chard, 2005; Fecteau and Nicki, 1999; Hinton et al., 2005; Keane et al., 1989; Monson et al., 2006; Rothbaum et al., 2005). All eight of these studies demonstrated a statistically significant im- provement with treatment to a primary PTSD scale or to the loss of PTSD diagnosis. One of these studies with no major limitations in male veterans with chronic PTSD showed both reductions in a primary PTSD scale and the loss of PTSD diag­nosis with cognitive processing therapy (a combina- tion of exposure and cognitive restructuring) (Monson et al., 2006). The committee identified eight additional RCTs comparing exposure therapies to an active control (coping skills training program or present- centered therapy). Four of the studies had major limitations, such as high dropout rates and either presenting only a completer analysis or using last observation carried forward (LOCF) despite dropout rates of up to The APA (2004) review of the literature identifies high rate of dropout as a challenge of exposure therapies.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 97 40 percent­ (Boudewyns et al., 1990; Marks et al., 1998, 2007; Taylor et al., 2003; Vaughan et al., 1994). Four studies had few or no limitations. One small study conducted among mostly female victims of abuse or MVA found substantial decrease in Clinician Administered PTSD Scale (CAPS) scores and loss of diagnosis (Bryant et al., 2003). One was conducted in male veterans with chronic PTSD showing no benefit of trauma-focused therapy administered in groups compared with present-centered therapy (Schnurr et al., 2003). Another study among female veterans with PTSD, 70 percent of whom nominated sexual assault as their index (worst) trauma, showed a benefit of individually administered exposure therapy (Schnurr et al., 2007). A single small study of female victims of sexual assault showed significant improvements in both a global PTSD scale and in loss of diag- nosis (Echeburua et al., 1997). The committee found it difficult to judge the validity of the results comparing exposure therapy to a coping skills training program or present-centered therapy overall because four of the eight studies had major limitations, but the remaining studies support the overall conclusion that exposure therapy is efficacious. Synthesis: The committee judged that the quality of the overall body of evidence supporting exposure therapies is moderate to high, with the best studies all pointing in the same direction with an important clinical benefit. The committee is confident in both the presence of a positive effect and in its clinical significance. Further research is likely to refine estimates of the effect in different settings and populations, but is unlikely to change confi- dence in the overall estimate of effect. Conclusion: The committee finds that the evidence is sufficient to con- clude the efficacy of exposure therapies in the treatment of PTSD. Comment The evidence for efficacy of exposure therapy in veterans—especially in males with chronic PTSD—is less consistent than the general body of evidence. Also, it should be noted that, as described above and in Appendix A, exposure therapies (e.g., prolonged exposure), as delivered often contain components of other CBT approaches, such as cognitive restructuring and coping skills training. Thus the conclusion that the evidence supports the efficacy of exposure therapy should not be interpreted too narrowly. Head-to-Head Comparisons Because the committee judged the evidence sufficient to establish e ­ fficacy of exposure therapies, it also reviewed the literature where an

98 TREATMENT OF POSTTRAUMATIC STRESS DISORDER exposure therapy was compared with some other intervention. If evi- dence strongly supported equivalency of the other therapy compared with e ­ xposure ­therapy, it would add support for the other therapy. We identi- fied seven such studies, but only one—a comparison of exposure therapy with cognitive restructuring in a mixed trauma population (Tarrier et al., 1999)—had no major limitations and it showed that the two therapies were equivalent. The study was small, however, so the committee could not judge whether it had adequate power to detect a clinically significant difference, and thus did not reach a conclusion regarding the equivalency of the two treatments. Exclusion Notes Several exposure trials were excluded because they were not random- ized (or only partially randomized) (Brady et al., 2001; Cloitre and Koenen, 2001; Cooper and Clum, 1989; Humphreys et al., 1999; Monson et al., 2005). Trials that did not include a comparison or control group were also excluded (Basoglu et al., 2003; Forbes et al., 2002;10 Frommberger et al., 2004;11 Najavits et al., 1998). Three trials included participants not formally diagnosed with PTSD, or only part of the sample was diagnosed so were excluded (Foa et al., 1995;12 Lubin et al., 1998;13 Valentine and Smith, 2001). There were also two studies where PTSD was not the main   fter this report was released an additional head-to-head study was brought to the com- A mittee’s attention (Ironson et al., 2002). Because of lack of clarity regarding inclusion criteria, the randomization protocol, and the treatment actually delivered, the study was uninformative regarding the principal comparison of PE to EMDR.  This study also looked at dual diagnosis (PTSD and cocaine addiction) and had a high dropout rate greater than 50 percent.  This was a naturalistic study where treatment was interpersonal process group therapy in patients with and without bipolar disorder.  Randomization was not 100 percent. Patients were assigned to standard treatment or standard treatment plus imaginal flooding.  Program evaluation.  This was a preliminary program effectiveness study that compared two variations of CBT in a veteran population.  Modified behavioral treatment given to N = 231 earthquake survivors; duration of treat- ment and improvement of symptoms were outcomes.   10Longitudinal trial examining predictors of response versus treatment efficacy.   11This trial compared paroxetine treatment (10–50 mg dosages given) versus CBT treat- ment (exposure and cognitive restructuring). PTSD and depression symptomatology were outcome variables. 12Subjects diagnosed with PTSD per Diagnostic and Statistical Manual of Mental Disorders, 3rd edition (DSM-III), but mean duration of illness was 15 days (9.40 for control), correspond- ing to the current definition for acute stress disorder. 13Patients only had PTSD symptoms, not PTSD diagnosis.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 99 study outcome, and neither study included overall PTSD outcome measures (Boudewyns and Hyer, 1990; Chemtob et al., 199714). Falsetti et al. (2003) was excluded because it is an additional analysis of Falsetti et al. (2001) that does not include PTSD outcome data (although it includes other data for the complete sample, unlike the 2001 publication, which was prelimi- nary). See Tables 4-1, 4-2, and 4-3 for a summary of included studies. EYE MOVEMENT DESENSITIZATION AND REPROCESSING The committee identified a diverse literature of 10 randomized trials of EMDR compared with various other therapies and wait list or alone compared with wait-list control. The mean age in these studies was in the 30s to the 40s (with a wider range for civilian studies, typically including participants from age 18 to the 70s, and a narrower range for studies in veterans, generally of the Vietnam War). The sex of participants varied in a pattern similar to that described in Chapter 3—in four studies where the trauma was combat, most or all participants were male; participants in the two studies with sexual assault/abuse victims were all female, and partici- pants with a variety of trauma types included a mix of men and women. Approximately half of the studies provided race/ethnicity data, with the range of white participants from 54 to 68 percent. Most studies reported duration of PTSD diagnosis or exposure to index trauma with a range from approximately 1 year in a study of occupational witnessing man-under- train accidents to two decades in the case of veterans. Treatment length ranged from 2 sessions to 10 weekly sessions, and duration of sessions was generally 90 minutes. Most studies provided information about therapists administering the treatment, and they typically were reported as being licensed, trained at master’s level or above, and having received EMDR training (some had level II training). Most therapists also were supervised. Some studies did not conduct follow-up after the completion of treatment, while others conducted follow-up at 3, 6, 12, or 15 months. Six trials had major limitations such as lack of assessor blinding or independence, high dropout rates, or weak (or no) treatment of missing values (Boudewyns et al., 1993; Jensen, 1994; Marcus et al., 1997; Power et al., 2002; Rothbaum, 1997; Silver et al., 1995). Four studies had few or no major limitations, and of those, two showed statistically significant improvement in CAPS score or a significant difference in loss of diagnosis in the treated group (Carlson et al., 1998; Hogberg et al., 2007; Rothbaum et al., 2005; van der Kolk et al., 2007). The study by Carlson and colleagues was a small trial in male veterans, and it showed no effect post-treatment. The study by van der Kolk and colleagues was an RCT comparing EMDR, 14Anger is main outcome. This trial was done with Vietnam War veterans.

100 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-1  Exposure Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Basoglu et al., Female, nat. Total (31) 100% CAPS 2007 disaster E (16) WL (15) Monson et al., Male, combat Total (60) ITT (random CAPS 2006 regression) E+CR (30) 80% WL (30) 87% Basoglu et al., Female, nat. Total (59) 100% CAPS 2005c disaster E+CR (31) WL (28) Chard, 2005 Female, Total (71) ITT (LOCF) CAPS sexual abuse E+CR (36) 83.3% MC (35) 80.0% Foa et al., 2005 Female, Total (179) ITT (BOCF)d PSS-I S&NS abuse E (79) 59% E+CR (74) 66% WL (26) 96% Hinton et al., Mixed sex, Total (40) None CAPS 2005 witness E+CR No dropouts genocide WL, then E+CRe McDonagh et al., Female, Total (74) ITT (LOCF) CAPS 2005 sexual abuse E+CR (29) 59% CS (22) 91% WL (23) 87% Rothbaum et al., Female, Total (72) ITT (but only CAPS 2005 sexual abuse, completer reported) assault 83.3% total E (23) 87.0% EMDR (25) 80.0% WL (24) 83.3%

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 101 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes No major limitations –32.9 Yes –13.2 Yes   76.73, 79.10 Yes No major limitations –24.59   –3.07 40%   3% Yes Yes NR No major limitations –23.4   –5.8 Yes   65.46, 68.30 Yes 93% No major limitations –56.5 26%   –5.3 Yes   35.1, 30, 35.5 NR High dropout handled –16.1 with BOCF, high –13.7 Yes differential dropout   –6.5 Yes Yes   74.85, 75.91 Yes 60% No major limitations –35.60 (compared to ­  0%, then   –2.86, then delayed WL 50% –28.00 group, no after WL treated ) Yes   69.9, 67.7, 72.0 High attrition handled –16.8 Yes 27.6% with LOCF, high –20.5 Yes 31.8% differential dropout   –6.5 17.4% Yes M(SD) NR Treatment of missing data not reported Yes 95% Yes 75% 10% continued

102 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-1  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Blanchard et al., Mixed sex, Total (98) ITT (reanalysis incl. CAPS 2004 MVA dropouts) E+CR (36) 75.0% CS (37) 72.9% WL (25) 96.0% Kubany et al., Female, abuse Total (125) ITTg CAPS 2004 E+CR-If (63) 73.1% E+CR-Df (62) 56.5% Neuner, 2004 Female, mixed Total (43) Restricted maximum PTSD likelihood procedure diagnosis E (17)   94% per PDS CS (14)   86% MC (12) 100% Kubany et al., Female, Total (37) ITT (LOCF) CAPS 2003 assault E+CR-If (19) 94.7% E+CR-Df (18) 77.7% Cloitre et al., 2002 Female, Total (58) ITT (LOCF) CAPS S&NS abuse E+CS (31) 71% WL (27) 89% Power et al., 2002 Mixed sex, Total (105) None IOEj MVA, other EMDR (39) 70% E+CR (37) 59% WL (29) 83% Resick et al., 2002 Female, Total (121) ITT (LOCF) CAPS sexual abuse, E+CR (41) 73.2% assault E (40) 72.7% MC (40) 85.1%

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 103 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes 68.2, 65.0, High dropout handled 65.8 with LOCF and high Yes 76.2% differential dropout –44.5 Yes 44.4% –24.9 –11.8 Yes   72.9, 71.9h High dropout handled –57.1 Yes 91% with LOCF and high –5.6, then No, then yes 80% differential dropout –49.8 Yes 25.2, 2.0, 19.5 (at 1-year No major limitations follow-up) –6.1 Yesi –2.2 No 71% +1.7 21% 20% Yes   80.9, 79.1 High dropout handled –70.8 Yes 94% with LOCF and high   –3.0, then Yes 93% differential dropout –67.5 Yes   69 NR High dropout handled –38 Yes with LOCF and high   –7 differential dropout Yes Yes NR High dropout, no –23.3 treatment of missing data, –13.5 high differential dropout   –3 Yes Relatively high dropout –35.68 Yes 53% handled with LOCF –31.71 Yes 53%   –0.59   2% continued

104 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-1  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Classen et al., Female, Total (55)k NR TSC-40l 2001 sexual abuse E+CR (14) Unclear CS (7) WL (34) Falsetti, et al. Female, mixed Total (22) NR CAPS 2001 trauma E (7) Unclear WL (15)m Fecteau and Nicki, Female, MVA Total (23) NR CAPS 1999 E+CR (12) 83% WL (11) 91% Foa et al., 1999 Female, mixed Total (96) ITT (LOCF) PSS-I assault E (25)   92% CS (26)   73% E+CS (30)   73% WL (15) 100% Glynn et al., 1999 Male, combat Total (42) CAPS NR; E (12) 100% positive (+)/ E+CSn (17)   65% negative (–) WL (13) 100% symptom factor score Boudewyns et al., Male, combat Total (20) NR CAPS 1993 EMDR (9) E (6) MC (5) Foa et al., 1991 Female, Total (55) Completer PTSD sexual assault CS-SIT (17)   82.4% severity E (14)   71.4% rating CS (SC) (14)   78.6% WL (10) 100.0%

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 105 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations NR NR NR High dropout handled –8.1 (both Tx No with LOCF and high groups) differential dropout, non- –3.8 standard PTSD measure; assessor blinding or independence not reported Yes M(SD) NR Dropout or completer Yes 91.7% numbers not reported 33.3% Yes   70.9, 77.3 50% No major limitations –33.4 Yes   0%   –2.7 Yes ~30 High dropout handled –17.8 Yes 60% with LOCF, high –16.5 Yes 42% differential dropout –16.4 Yes 40%   –6.0 —   0% Yes Unclear No NR High dropout and differential, key data not reported NR NR No NR No reporting of dropout (only or completer numbers, no physiological reporting of blinding or measures independence, CAPS data given) not reported (other data not relevant) Yes ~24–25 (Pre-Tx vs. High dropout, completer –13.41 follow-up)   50% analysis only, high –10.34 Yes   40% differential dropout   –6.30 Yes   90%   –4.93 No 100% continued

106 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-1  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Keane et al.,1989 Male, combat Total (24) N/A MMPI- E (11) 100% PTSD WL(UC) (13) 100% aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cThis study did not have a typical endpoint, because the treatment was a single session, and the “endpoint” was the 6-week post-treatment assessment. dPre-Tx scores for dropouts. eImmediate vs. delayed E+CR groups; 2nd group served as control, then began Tx after group 1 completed 12 sessions. fI = immediate; D = delayed. TABLE 4-2  Exposure Studies Using an Active Control Only Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Schnurr et al., Female, Total (284) ITT (multiple CAPS 2007 mixed, E (141) imputation)c combat PCT (143) 62% 79% Bryant, 2003 Female Total (58) ITT (LOCF) CAPS (Male), abuse, 75.0% Intensity MVA 75.0% (I) and E (20) 83.3% Frequency E+CR (20) (F)e CSd (18)

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 107 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations No ~36 NR No assessor blinding or   –7.6 No independence   –4.6 gThe investigators (Basoglu et al., 2005) conducted intent-to-treat analyses on the data by evaluating outcomes for all participants who were randomly assigned, using pre-treatment data scores for post-treatment scores for nonstarters and non-completers. hThe delayed group had two pre-therapy assessments: 77.5 and 71.9 CAPS, coinciding with the post-therapy assessment for the immediate group. iAnalysis reported for 1-year follow-up only, not reported post-test (change at 1 year: 9.2, –1.1, –4.4). jCAPS subscales are primary study outcome measure. kThe investigators reported that 3 of 58 dropped out before beginning of treatment, but ap- parently after randomization. However, they were not included in the actual reported dropout figure. Also, the number of patients in the control arm was calculated by subtracting 14 + 7 from 55. lTrauma Symptom Checklist 40 (Elliott and Briere, 1991, 1992). mThis was a preliminary analysis. Five of WL group were crossed over to treatment—data breakdown was not reported. A further analysis of the completed study was in press after the ����������������������������������������������������������������� release of this IOM report, so it could not be included in the committee’s review. nBehavioral family therapy. Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes 38% dropout handled –24.7 Yes 41.0% appropriately; 17% –17.8 27.8% differential dropout (odds ratio 1.8) Yes ~32 (I) No major limitations 36.80/36.00/ 50% 38.33 (F) 65% –16.07, –20.8 Yes, no 33% –22.4, –25.07 Yes, yes –8.14, –13.13 continued

108 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-2  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Schnurr et al., Male, combat Total (360) Mixed model CAPS 2003 E+CR (180) 66% CS: PCT (180) 75% Taylor et al., 2003 Female, mixed Total (60) ITT (LOCF) CAPS E (22) 68% EMDR (19) 79% CS (19) 79% Marks et al., 1998 Male Total (87) ITT (LOCF) CAPS (Female), E (23) 57% mixed CR (19) 63% E+CR (24) 54% CS (21) 67% Echeburua et al., Female, Total (20) 100% Global 1997 sexual assault, E+CR (10) scale of abuse CS (10) PTSD (0–51) Vaughn et al., Female Total (36) 100% SI-PTSD 1994 (Male), mixed EMDR (12) E (IHTf) (13) CS (11) Boudewyns and Male, combat Total (58) NR VETS Hyer, 1990 E (26) PCT (32) aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 109 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes 80.41, 82.01 No ≥10 pts CAPS No major limitations –6.41 ↓ (34% dropout well –5.98 38.8% handled) 37.5% Yes 2 standard 32% dropout handled NR Yes deviations with LOCF No decrease in score but reported by symptom category Yes NR NR Dropout from 33% –30 Yes 25% to 46% handled with –36 Yes 35% LOCF –38 Yes 37% –14 45% Yes   32.5 No major limitation –19.8 Yes 90% –11.3 10% Yes –8.0 (E and All subjects EMDR groups) No 78% baseline Data for active –1.7 47% endpoint treatment arms aggregated NR NR Unclear NR No dropout or completer numbers reported, no outcomes or effect data reported scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cWith Markov chain Monte Carlo method. dSupportive therapy and counseling. eTotal CAPS scores not reported. fImage habituation training.

110 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-3  Head-to-Head Exposure Studies, No Control (Exposure) Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Van Minnen and Mixed sex, Total (92) ITT (LOCF) PSS-I Foa, 2006 domestic and E(PE) (60) 77% job violence, E (32) 84% sexual assault Hembree, 2004 Female, Total (75) NR PSS-I S&NS assault E (41) E+CR (34) Otto et al., 2003 Female, Total (10) NR CAPS genocide, SSRI (5) war (all on SSRI+CBT (5) clonazepam) Lee et al., 2002 Mixed sex, Total (24)c NR, unclear SI-PTSD NR EMDR (12) 76.9 or 71.4 E+CS (12) 84.6 or 78.6 Paunovic and Ost, Mixed sex, Total (16) NR CAPS total 2001 refugees E (8) 80% severity E+CR (8) Devilly and Mixed sex, Total (32) NR PSS-SR Spence, 1999 mixed trauma E+CR (15) 80% EMDR (17) 65% Tarrier et al., 1999 Mixed Total (72) NR CAPS sex, crime, CR (37) 89% accidents, E (35) 83% other aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 111 Baselineb and Assessor Change in Statistically Loss of Blinded? PTSD Measure Significant? Diagnosis (%) Principal Limitations NR   25.9, 27.2 No NR Assessor blinding or –11.1 (shows 30 min independence not reported –12.9 E as effective as 60 min E) NR NR NR Not reported No dropout or completer by arm numbers reported; assessor blinding or independence not reported NR   57.2, 64.6 Unclear (no NR No dropout or completer   +4.6 P values), but numbers reported; assessor –14 combined had blinding or independence “dramatic” not reported; very small effect compared sample size to modest effect of SSRI alone Nod   37.58, 42.25 No No method of handling –20.58 (yes compared 83% dropout reported; assessor –17.17 to 2nd 75% blinding or independence assessment not reported during wait-list period) No   98.4, 95.1 Dropout data aggregated –52.4 Yes 25% for both arms; assessor –56.1 Yes blinding or independence not reported NR   36.25, 35.09 35% dropout without –21.83 Yes (superior) 58.33% adequate treatment; 15% –10.45 27.27% dropout differential; assessor blinding or independence NR Yes   77.76, 71.14 No No major limitations –26.94 42% –22.9 59% scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cIt is unclear from the authors’ reporting how many people were randomized. 29 were screened, 2 dropped out before randomization, and the authors report that 3 patients dropped out of treatment—one from E+CS, one from EMDR, and one “went to prison.” The treatment condition of the patient who went to prison is unclear. dBut, the authors note, self-reported data were consistent with interview data.

112 TREATMENT OF POSTTRAUMATIC STRESS DISORDER fluoxetine, and placebo, and failed to show significant improvement despite the LOCF treatment of missing values that in this case should have biased the study toward showing a positive outcome. The committee also identified two RCTs comparing EMDR with a cop- ing skills training therapy, namely, applied muscle relaxation and relaxation training (Taylor et al., 2003; Vaughan et al., 1994). However, both studies had major limitations such as high dropouts or uninterpretable aggrega- tion of data, and in any case neither demonstrated a statistically significant benefit. The committee noted that some experts have questioned whether the eye movement component adds benefit to the reprocessing component, but the committee identified no adequately designed studies testing the hypoth- esis and so was unable to reach a conclusion. Synthesis: The committee found the overall body of evidence for EMDR to be low quality to inform a conclusion regarding treatment efficacy. Four studies, three of medium and one of small sample size, had no major limi- tations, but only two showed a positive effect for EMDR. The committee is uncertain about the presence of an effect, and believes that future well- designed studies will have an important impact on confidence in the effect and the size of the effect. Conclusion: The committee concludes that the evidence is inadequate to determine the efficacy of EMDR in the treatment of PTSD. Exclusion Notes Three trials that did not include a comparison or control group were excluded (Ironson et al., 2002; Raboni et al., 2006; Rogers et al., 1999) as were comparison studies (Cusack and Spates, 1999; Devilly and Spence, 1999; Lee et al., 2002; Pitman et al., 1996). Many trials included partici- pants not formally diagnosed with PTSD, or only part of the sample was diagnosed so were excluded (Devilly et al., 1998;15 Renfrey and Spates, 1994;16 Sanderson and Carpenter, 1992;17 Scheck et al., 1998;18 Wilson et 15War veterans with PTSD “symptomatology.” 16Patients “were screened positive for traumatic events as defined by the DSM-III-R, and ex- perienced current intrusive symptoms as similarly defined.” This trial evaluated active compo- nents of EMDR, standard EMD, a variant of EMD in which eye movements were engendered with light tracking task, and a variant of EMD with fixed visual attention. 17The patient sample from this trial only included those with phobias, and a subgroup of phobias that “nearly resemble” PTSD. 18PTSD diagnosis was not a requirement for study inclusion. In addition this sample included patients ages16–25, so did not meet the committee’s criteria for only adult populations.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 113 al., 1995, 199719). The committee also identified a progress report for an ongoing 3-year study with selected results; only preliminary findings were available so it was not included on the review (Boudewyns and Hyer, 1996). See Tables 4-4 and 4-5 for a summary of included studies. COGNITIVE RESTRUCTURING The committee identified three RCTs of cognitive restructuring com- pared with coping skills training or an educational booklet. One study suffered high dropout rates (up to 46 percent) and used LOCF to address missing data. Another study with no major limitations showed no differ- ence between cognitive restructuring and exposure-focused therapy, but had no control group (Tarrier et al., 1999). A second trial with no major limitations conducted in individuals who had experienced a motor vehicle accident had a modest dropout rate handled by LOCF, and showed signifi- cant improvement on CAPS and loss of diagnosis (Ehlers and Clark, 2003). However, the committee was reluctant to judge cognitive restructuring on the basis of this single trial in victims of motor vehicle accidents. Synthesis: The committee judged the overall body of evidence on cognitive restructuring in the treatment of PTSD to be moderate quality, but there were important limitations. Although the three studies identified were all of medium size and two were reasonably well-conducted, one of the two did not find an effect and the other found a large effect. The committee is uncertain about the presence of an effect, and believes that future well- designed studies will have an important impact on confidence in the effect and the size of the effect. Conclusion: The committee concludes that the evidence is inadequate to determine the efficacy of cognitive restructuring in the treatment of PTSD. Exclusion Notes The committee did not identify any studies on cognitive restructuring alone to exclude. See Table 4-6 for a summary of included studies. 19Less than half of the 2005 study participants met PTSD diagnosis. Separate results for those with and without PTSD not provided except for one supplemental analyses for those with PTSD. The 1997 follow-up study did analyze PTSD versus non-PTSD patients separately, however there was no longer a control group so the study is uninformative with regard to the core question of efficacy.

114 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-4  EMDR Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Hogberg et al., Male, Total (24) 100% GAF 2007 witnessing EMDR (13) and loss of WL (11) diagnosis (SCID) van der Kolk Female, Total (88) ITT (LOCF) CAPS et al., 2007 S&NS abuse, SSRI (30) 87% injury EMDR (29) 83% PL (29) 90% Rothbaum et al., Female, Total (72) ITT (NR) CAPS 2005 sexual abuse E (23) 87.0% EMDR (25) 80.0% WL (24) 83.3% Power et al., 2002 Mixed sex, Total (105) None IOEd MVA, other EMDR (39) 70% E+CR (37) 59% WL (29) 83% Carlson et al., Male, combat Total (35) NR IES 1998 EMDR (10) 100% CS (13)   92.3% UC (12) 100% Marcus et al., Female, Total (67) Not clear IES 1997e S&NS abuse EMDR (33 or 34) SC (34 or 33) Rothbaum, 1997 Female, Total (21)g Completer PSS-I sexual assault EMDR (10) total 85.7% WL (8) Silver et al., 1995 Male, combat Total (83) NR PRF EMDR (13) CS-R (9) CS-B (6) MC (55)

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 115 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes ~64c Yes No major limitations –14.5 67%   –1.9 11% Yes NR No No major limitations –33.23 73% –39.15 76% –30.95 59% Yes M(SD) NR No major limitations Yes 95% (but outcome data not Yes 75% reported) 10% Yes   35.1, 32.7, 32.6 NR 41% dropout; no –23.3 treatment of missing data –13.5 Yes   –3 Yes Yes ~52 (at 3-month No major limitations follow-up) –17.3 No 77.77% (of 9)   –8.4 No 22.22% (of 9) –14.1 Yesf   46.09, 49.70 Dropout or completer –28.2 numbers not clear –14.7 Yes 77% 50% Yes   33.3, 39 No breakdown of dropout –19 Yes 90% ratesg   –4 12% NR No single Yes (on 5 of 8 NR No dropout or completer measure, 8 PRF scales) data reported; assessor symptom scales blinding or independence not reported; nonstandard outcome measure and uninterpretable data continued

116 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-4  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Jensen, 1994 Male, combat Total (25) 100% SI-PTSD EMDR (13) WL (12) Boudewyns et al., Male, combat Total (20) NR CAPS 1993 EMDR (9) E (6) MC (5) aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cHigher Global Assessment of Functioning (GAF) scores mean improvement, so the change was 64.0 to 78.9 for the treatment group, and 64.9 to 66.8 for the WL group. TABLE 4-5  EMDR Studies Where Coping Skills Are the (Only) Control Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Taylor et al., 2003 Female, Total (60) ITT (LOCF) CAPS assault, E (22) 68% accidents EMDR (19) 79% CS (19) 79% Vaughn et al., Mixed Total (36) 100% SI-PTSD 1994 sex, mixed EMDR (12) traumac E (IHTd) (13) CS (11) aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 117 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations NR 29.92, 37.08 Assessor blinding or –5.77 No NR independence not reported –9.88 NR NR No NR No dropout or completer numbers reported; no outcome dIOE is Impact of Events Scale (also known as IES). The three CAPS subscales were the primary study outcome measure. eFollow-up in the Marcus et al., 1997, study was further analyzed in Marcus et al., 2004. fBlind assessment was affected by client revelations. gThe numbers randomized to each arm are unclear, but may be deduced to be either 11 or 10 for either, meaning that with completer numbers of EMDR 10 and WL 8, the respective dropout rates were either 0 for EMDR (100% completed) and 3 for WL (73% completed), or 1 for EMDR (91% completed) and 2 for WL (80% completed). The article states that two of the three patients who dropped out were assigned to WL, so one could conclude that the third patient that dropped out was probably assigned to EMDR. If that is true, the dropout rates would have been 91% and 80% for EMDR and WL, respectively. Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes 2 standard 32% dropout handled NR Yes deviations with LOCF No decrease in score but reported by symptoms category Yes NR All subjects Outcome data aggregated, –8.0 (E and No 78% baseline uninterpretable EMDR groups) 47% endpoint –1.7 cAt entry to the study all patients satisfied DSM-III-R Category B (reexperiencing/intrusive) and Category D (hyperarousal) criteria for PTSD. However 22% failed to qualify for a diag- nosis of PTSD because they had less than the three required Category C (avoidance, numb- ing) symptoms. “This is a symptom pattern common in community samples (Creamer, 1989; Solomon­ and Canino, 1990) and has promoted moves to reduce the number of Category C criteria from three to two in DSM-IV (Davidson and Foa, 1993)” (Vaughn et al., 1994). dImage habituation training.

118 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-6  Cognitive Restructuring Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Ehlers et al., 2003 Sex NR, MVA Total (85) ITT CAPS frequency CR (28) 100% (F) and MCc (28)   89% intensity (I) MCd (29)   93% scorese,f Tarrier, et al., Mixed sex, Total (72) NR CAPS 1999h crime CR (37) 89% E (35) 83% Marks et al., 1998i Mixed sex, Total (87) ITT (LOCF) CAPS mixed trauma E (23) 57% CR (19) 63% E+CR (24) 54% CS (21) 67% aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. COPING SKILLS THERAPIES The committee found 10 RCTs of coping skills training compared to minimum care, or compared to another treatment modality and minimum care. Most of the trials had major limitations including high rates of dropout, inadequate handling of missing values, high differential drop- out among arms, and lack of assessor blinding or independence. Only 2 of 10 studies had no noteworthy limitations, but neither found an effect (Carlson et al, 1998; Neuner et al., 2004). Most of the remaining studies (six of eight) (Blanchard et al., 2004; Foa et al., 1999; Hien et al, 2004; McDonagh et al., 2005; Silver et al., 1995; Zlotnick et al., 1997) showed an effect, but had major limitations that severely weakened confidence in the results. Synthesis: The committee judged that the overall body of evidence on cop- ing skills training was low quality to inform a conclusion regarding efficacy. The committee is uncertain about the presence of an effect, and believes

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 119 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes F I per PDSg No major limitations ~32f ~26   20.5   16.5 Yes 85.7%    9.7    7.1 21.4%    7.2    3.5 27.6% Yes   77.76, 71.14 No major limitations –26.94 No 42% –22.9 59% Yes NR NR Dropout from 33% to –30 Yes 75% 46% handled with LOCF –36 Yes 65% –38 Yes 63% –14 55% cSelf-help booklet. dRepeated assessments. eCAPS frequency and intensity scores were reported, but no CAPS total provided. fIn Ehlers et al., 2003, the 3-month follow-up was considered the post-treatment point (p. 1029). gPosttraumatic Diagnostic Scale. hNo control. iCS is the only control. that future well-designed studies will have an important impact on confi- dence in the effect and the size of the effect. Conclusion: The committee concludes that the evidence is inadequate to determine the efficacy of coping skills therapies in the treatment of PTSD. Exclusion Notes The committee excluded one study comparing three different coping skills with no control group (Watson et al., 1997). See Table 4-7 for a sum- mary of included studies. OTHER PSYCHOTHERAPIES The committee identified four individual trials of other psychothera- pies—eclectic psychotherapy, hypnotherapy, psychodynamic therapy, and

120 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-7  Coping Skills Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure McDonagh, 2005 Sex NR, Total (74) ITT (LOCF) CAPS sexual abuse E+CR (29) 59% CS (22) 91% WL (23) 87% Blanchard et al., Mixed sex, Total (98) ITT (reanalysis incl. CAPS 2004 MVA dropouts) E+CR (36) 75.0% CS (37) 72.9% WL (25) 96.0% Hien et al., 2004 Female, Total (107) ITT (LOCF+)e CAPS interpersonal CS (41)c   61% violence CS (34)d   71% MC (32) 100% Neuner et al., Mixed sex, Total (43) Restricted maximum PTSD 2004 war refugees likelihood diagnosis E (17)   94% per PDS CS (14)   86% MC (12) 100% Classen et al., Female, Total (55)g NR TSC-40h 2001 sexual abuse E+CR (14) Unclear CS (7) WL (34) Foa et al., 1999 Female, mixed Total (96) ITT (LOCF) PSS-I assault E (25)   92% CS (26)   73% E+CS (30)   73% WL (15) 100%

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 121 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes   69.9, 67.7, 41% dropout handled   72.0 Yes 27.6% with LOCF; 28% –16.8 Yes 31.8% differential dropout –20.5 17.4%   –6.5 Yes   68.2, 65.0,   65.8, DO 69.2 27.1% dropout rate; 21% Yes 76.2% differential dropout –44.5 Yes 44.4% –24.9 –11.8 No ~72 NR –15.02 39% dropout handled –19.17 Yes with LOCF and mean   –5.88 Yes replacement; 39% differential dropout; no assessor blinding or independence Yes 25.2, 2.0, 19.5 (at 1-year follow-up) No major limitations –6.1 Yesf –2.2 No 71% +1.7 21% 20% NR NR No NR Dropout or completer –8.1 (both Tx numbers not reported; groups) no assessor blinding or –3.8 independence not reported; outcomes reported aggregated for treatment groups Yes ~30 27% dropout handled –17.8 Yes 60% with LOCF; 27% –16.5 Yes 42% differential dropout –16.4 Yes 40%   –6.0 —   0% continued

122 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-7  Continued Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Carlson et al., Male, combat Total (35) NR IES 1998 EMDR (10) 100% CS (13)   92.3% UC (12) 100% Zlotnick, 1997 Female, Total (48)i Completers DTS childhood CS (17) 71% sexual abuse WL (16) 75% Silver et al., 1995 Male, combat Total (83) NR PRF EMDR (13) CS-R (9) CS-B (6) MC (55) Foa et al., 1991 Female, Total (55) NR PTSD sexual assault CS-SIT (17)   82.4% severity E (14)   71.4% rating CS (SC)j (14)   78.6% WL (10) 100% aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cSeeking-safety therapy. dRelapse prevention therapy (a substance abuse treatment was used as a comparator, not as PTSD treatment). brainwave neurofeedback. The usefulness of one of the two trials of eclectic psychotherapy was severely limited by a 42 percent dropout rate handled with LOCF (Lindauer et al., 2005); the other, conducted among police officers (Gersons et al., 2000), had no major limitations and showed a s ­ ignificant difference in loss of PTSD diagnosis (Gersons et al., 2000; Lindauer et al., 2005). The trial of hypnotherapy and psychodynamic therapy had only one major limitation and showed a significant decrease

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 123 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes ~52 (at 3-month No major limitations follow-up) –17.3 No 77.77% (of 9)   –8.4 No 22.22% (of 9) –14.1 No (self-   66.88, 74.69 report) –21.12 Yes 87% 29% dropout rate with   –1.63 41% completers analysis NR No single Yes (on 5 of 8 NR Dropout or completer measure, 8 PRF scales) numbers not reported; symptom scales non-standard, multiple scale PTSD measure and no total reported Yes ~24–25 (Pre-Tx vs. 28.6% dropout; method follow-up)   50% of handling missing data –13.41 Yes   40% not reported; no adequate –10.34 Yes   90% treatment of missing data;   –6.30 No 100% 28.6% differential dropout   –4.93 eThe authors report that they also tested “mean replacement” to address missing data, yield- ing results no different from LOCF. fAnalysis reported for 1-year follow-up only, not reported post-test (change at 1 year: 9.2, –1.1, –4.4). gThe investigators reported that 3 of 58 dropped out before beginning treatment but after randomization. However, these were not included in the actual reported dropout figure. Also, the number of patients in the control arm was calculated by subtracting 14 + 7 from 55. hTrauma Symptom Checklist-40. iFifteen dropped out. jIn this study CS was used as an active control, not as a treatment arm. in change from baseline to post-treatment measures for each treatment arm (Brom et al., 1989). The trial of brainwave neurofeedback in Vietnam vet- erans with chronic PTSD used the Minnesota Multiphasic Personality Inven­ tory (MMPI)-PTSD lacked assessor blinding or independence ­(Peniston and Kulkosky, 1991). Based on this extremely limited body of evidence, the committee believes that it would be inappropriate to reach a conclusion regarding the efficacy of any of these treatments.

124 TREATMENT OF POSTTRAUMATIC STRESS DISORDER Exclusion Notes Several case studies and series, uncontrolled trials, and RCTs have been conducted on various psychotherapies not included in the classes outlined above. Several other studies were excluded, and the reasons are briefly described here. Three trials were excluded because they were not random- ized (or only partially randomized) (Ragsdale et al., 199620) or did not include a comparison or control group (Forbes et al., 2003;21 Zayfert et al., 200522). Many trials included participants not formally diagnosed with PTSD, or only part of the sample was diagnosed so were excluded (Classen et al., 2001; Igreja et al., 2004;23 Krakow et al., 2000, 2001;24 Lange et al., 2001, 2003;25 Solomon et al., 1992;26 Zatzick et al., 200427). In one study, PTSD was not the primary study outcome, and the study did not include an overall PTSD outcome measure (Ouimette et al., 199728). The committee also identified two program reviews that were not included in this review (Hammarberg and Silver, 1994;29 Johnson et al., 199630). See Table 4-8 for a summary of included studies. GROUP THERAPY The committee noted that any psychotherapy can be administered in a group format, and was aware that group formats are commonly used in 20Trial examined short-term specialized inpatient treatment for war-related PTSD (adven- ture-based counseling and psychodrama). 21This was a pilot study using imagery rehearsal as the treatment. 22Assessed rates of exposure therapy (ET) and completed CBT for PTSD in a clinical setting and looked at predictors of completion. Illustrated therapeutic challenges in real-world clinical practice (as opposed to in the context of a study). 23Trial used a testimony method intervention in rural community survivors of war; case and noncase group; “case” group randomly divided into testimony method or control. 24Patients had PTSD symptoms coupled with clear criterion A trauma link(s). Treatment was sleep-imagery rehearsal. 25Patients had mild to severe posttraumatic stress (not PTSD diagnosis). Treatment was Interapy or Internet therapy, vs. a wait-list control condition. 26This was a cohort study where some patients had combat stress reaction, some PTSD. It compared veterans who participated in the Koach program vs. veterans who did not. Koach used behavior therapy (flooding) with a focus on functioning in a military-type setting that exposed veterans to anxiety-provoking stimuli. 27Mixed diagnosis—PTSD symptomatology (but not actual PTSD) and/or depression. Sub- jects were trauma patients receiving medical care immediately after the trauma, and although some were acutely stressed, diagnosis of PTSD was not made until the 3-month follow-up. 28Impact on PTSD symptoms not assessed, and main treatment was for substance abuse (substance abuse and psychosocial outcomes examined 1 year after VA inpatient substance abuse treatment). 29Treatment involved multiple modalities. 30Program evaluation of a three-phase inpatient program.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 125 veteran populations. Ideally there would be evidence regarding the com- parative effectiveness of a given therapy in individual and group formats, with some indication of the population or subpopulation characteristics that would make one or the other more effective. However, only four studies examining group formats, and all using CBT approaches31 met the committee’s inclusion criteria, combining various components of exposure, restructuring, and coping skills training. They are discussed below. In general, studies of exposure (including studies of exposure plus cog- nitive restructuring and exposure plus coping skills training) administered the treatment in individual, rather than group sessions. Exceptions include Schnurr et al. (2003), Falsetti et al. (2001), and Chard et al. (2005), which are discussed in more detail below. The committee also identified a fourth study that employed a group therapy comparing affect management (a type of coping skills training) used as an adjunct to ongoing psychotherapy and pharmacotherapy to wait list (Zlotnick et al., 1997). This study found a benefit to group therapy, but had dropout rates of 25 and 29 percent handled only with completers analysis. The authors further acknowledge that the lack of standardization in concurrent treatment (including drugs administered) limited the validity of the study. Schnurr el al. (2003), Falsetti et al. (2001), and Chard et al. (2005) showed mixed effect of various types of group therapy on PTSD symp- toms. The large and well-conducted Schnurr et al., 2003, study in veter- ans compared group trauma-focused to group present-focused therapy. Although post-treatment assessments of PTSD severity significantly im- proved from baseline, there were no differences between treatment groups for any outcome. The Falsetti et al. (2001) study had a small sample size, was conducted in a population with mixed trauma, and showed an effect but was a preliminary analysis (study was not complete) and included a control-then-treatment group. The medium-size Chard et al. (2005) study did not have major limitations and found an effect, but it alternated individ- ual and group therapy (9 weeks of both, 7 weeks of group therapy, and the final week of individual therapy) in its treatment arm, making it difficult to ascertain which component of the therapeutic approach was efficacious. In addition to the Schnurr et al. (2003) study in a veteran population, the com- mittee made note of another large study (Creamer et al., 2006) in veterans that showed mixed effect on PTSD symptoms, but the Creamer study was a large case-series without a control (so was not included in the committee’s review). Schnurr et al. (2003) found no significant differences in outcome between the two types of group intervention (analysis of patients receiving 31Foa et al. (2000) describe two other types of group therapy for which the committee did not find RCTs: group psychodynamic therapy and supportive group therapy.

126 TREATMENT OF POSTTRAUMATIC STRESS DISORDER TABLE 4-8  Other Psychotherapies Handling of Dropouts PTSD and % Completed Tx Outcome Study Populationa Arm (N) by Arm Measure Lindauer et al., Mixed sex, Total (24) ITT PTSD 2005 mixed trauma OT (BEP)c (12) 58% diagnosis WL (12) 92% per SI-PTSD Gersons et al., Mixed sex, Total (42) NR PTSD 2000 police work OT (BEP) (22) 100% symptomsd WL (20)   95% (SI-PTSD data NR) Peniston and Total (29) MMPI- Kulkosky, 1991 Male, trauma OT (BN)f (15) PTSD type NR UCg (14) 100% Brom et al., 1989 Mixed sex, Total (112) NR IES Total mixed trauma E (31) 90.3% OT (H)h (29) 89.7% OT (P)i (29) 89.7% WL (23) 86.9%+ aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma. bPTSD outcome measure change data were obtained either directly from the study, when provided, or by subtracting data reported at treatment completion (not follow-up data) from baseline data (before treatment began). Average baseline score when reported or when baseline scores for all arms are nearly the same; otherwise, baseline scores listed individually in order of arm. cBrief eclectic psychotherapy, a combination of CBT and psychodynamic approaches includ- ing relationship and work issues. what was considered an adequate dose of 80 percent of treatment sessions). See Table 4-9 for a summary of included studies. Synthesis: The committee judged the overall body of evidence regarding group therapy formats to be low quality to inform a conclusion regarding efficacy because of the lack of well-designed studies comparing group and individual formats and including appropriate controls. The committee is uncertain about the presence of an effect, and believes that future well- designed studies will have an important impact on confidence in the effect and the size of the effect.

EVIDENCE AND CONCLUSIONS: PSYCHOTHERAPY 127 Baselineb and Statistically Assessor Change in Significant? Loss of Blinded? PTSD Measure (versus control) Diagnosis (%) Principal Limitations Yes 100.0% Same as 42% dropout –83.3% Yes baseline and –25.0% change Yes 11.5e No major limitations (but –8 Yes 91% broken –3 50% in 4 Ss) No No relapse No assessor blinding or Yes at 30 months independence   31, 36 –21 80%   –0   0% NR NR Assessor blinding or 19.4 Yes independence not reported 17.1 Yes 13.6 Yes   4.6 dOutcome measure was “recovery proportions,” including no PTSD and fewer than six symptoms (SI-PTSD used to determine both). eData not provided; figures estimated based on visual inspection of a bar graph, with the help of a ruler. fBrainwave neurofeedback. gUsual care. hHypnosis. iPsychodynamic therapy. Conclusion: The committee concludes that the evidence is inadequate to determine the efficacy of group therapy formats in the treatment of PTSD. SUMMATION Based on its assessment of the psychotherapy approaches for which randomized controlled trials were available—exposure, EMDR, cognitive

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Mental disorders, including posttraumatic stress disorder (PTSD), constitute an important health care need of veterans, especially those recently separated from service. Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence takes a systematic look the efficacy of pharmacologic and psychological treatment modalities for PTSD on behalf of the Department of Veterans Affairs. By reviewing existing studies in order to draw conclusions about the strength of evidence on several types of treatment, the Committee on the Treatment of Posttraumatic Stress Disorder found that many of these studies were faulty in design and performance, and that relatively few of these studies have been conducted in populations of veterans, despite suggestions that civilian and veteran populations respond differently to various types of treatment. The committee also notes that the evidence is scarce on the acceptability, efficacy, or generalizability of treatment in ethnic and cultural minorities, as few studies stratified results by ethnic background.

Despite challenges in the consistency, quality, and depth of research, the committee found the evidence sufficient to conclude the efficacy of exposure therapies in treating PTSD. The committee found the evidence inadequate to determine efficacy of different types of pharmacotherapies, of three different psychotherapy modalities, and of psychotherapy delivered in group formats. The committee also made eight critical recommendations, some in response to the VA's questions related to recovery and the length and timing of PTSD treatment, and others addressing research methodology, gaps in evidence and funding issues.

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