An interventional study of Group Based Exposure Therapy and Present Centered Group Therapy in Posttraumatic Stress Disorder, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2015-03-26.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
The purpose of this randomized controlled trial is to determine if Group Based Exposure Therapy (GBET) is more effective than treatment as usual in reducing the symptoms of war-related Posttraumatic Stress Disorder (PTSD).
Over 250,000 veterans with war-related PTSD were treated in the VA system in the VA system last year. Although the VA set up over 140 specialized PTSD programs and 206 Vet Centers to treat these veterans, a survey of practice patterns suggests that most VA PTSD treatment is not consistent with published treatment guidelines. This is mainly due to the very rare use of exposure therapy which is surprising considering that there is more empirical support for exposure therapy than for any other PTSD treatment. The failure to utilize evidence-based treatment may explain why studies have generally failed to support the efficacy of VA PTSD treatment. Group Based Exposure Therapy (GBET) is consistent with PTSD treatment guidelines and includes a large amount of exposure therapy. An open trial of 102 war veterans suggests that GBET produces clinically significant and lasting PTSD symptom reductions, as measured by the Clinician Administered PTSD Scale (CAPS), with a large effect size of 1.20 (generalized d). Clinically significant symptoms reductions, defined as a reduction in total CAPS score of 10 or more points, were found in 81 percent of patients. These symptom reductions were maintained on 6-month post-treatment assessments for most patients. Self-report measures of depression, anger, suicidal ideation and PTSD were also significantly reduced when pre-treatment measures were compared to post-treatment scores. This magnitude of symptom change has rarely been reported with VA war-related PTSD patients and there was a low dropout rate (>3%). Caution should be used in interpreting these unusual findings due to the treating clinicians conducting study assessments. Unconscious bias or a desire by patients to please their therapists may have affected outcomes. GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking. Although these findings are encouraging critical questions remain about the generalizability of GBET. The three primary questions are: 1) would similar outcomes be found with the more rigorous test of a randomized controlled trial, 2) can new psychotherapists produce similar outcomes, and 3) can similar outcomes be found at other sites. The proposed study would take the next step by conducting the first controlled trial in which 88 veterans with war-related PTSD will be randomly assigned to either GBET or Treatment as Usual control condition (44 per condition). GBET treatment would be provided by four psychotherapists without prior GBET experience. Independent Assessors blind to treatment condition would assess patients prior to treatment, at post-treatment, 6-months post-treatment and one year post-treatment using CAPS and other standardized measures. If GBET is supported, multi-site study will be proposed to investigate the third primary question.
Potential Impact on Veteran Health Care: GBET was developed within a specialized PTSD program, by VA clinicians working with war veterans and has been a primary mode of treatment within this program for over three years. Most VA PTSD programs have staffing similar to the one the developed GBET and many have more staff. GBET is manualized and could be adopted easily by other VA PTSD programs and Vet Centers. The proposed study would serve as a feasibility study for a multi-site study. If a multi-site study found that GBET produced superior treatment outcomes to those currently in use, it could have a direct impact on the lives of a large number of veterans by leading to better PTSD treatment within the VA.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Exclusion criteria are intended to exclude patients who might be harmed by study participation and to yield as ecologically valid a sample as possible.
Behavioral: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
Behavioral: Group Based Exposure Therapy
Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus. This lasted for 16 weeks.
Behavioral: Present Centered Group Therapy
GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus.
Clinician Administered PTSD Scale (CAPS)
This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.
Time frame: Pre treatment, Post treatment (16 weeks) and One year post treatment
Posttraumatic Cognitions Inventory (PTCI)
This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD
Time frame: Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment
170 male, Vietnam era veterans referred for PTSD treatment were informed about the study, 98 consented to participate, 11 dropped out before randomized, 6 were excluded due to (3)psychosis or manic symptoms and 3 did not have PTSD. 40 were assigned to PSGT and 41 to GBET. One assigned to GBET, dropped out during the first week and was replaced.
| Milestone | Group Based Exposure Therapy | Present Centered Group Therapy |
|---|---|---|
| Started | 41 | 40 |
| Completed | 37 | 39 |
| Not completed | 4 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 |
This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.
| units on a scale | Group Based Exposure Therapy | Present Centered Group Therapy |
|---|---|---|
| Pre treatment | 82.4 ± 15.09 | 81.18 ± 14.31 |
| Post treatment[ | 71.73 ± 20.55 | 75.43 ± 23.01 |
| one yr post tx (N= 35 GBET & N=33 PCGT | 69.29 ± 20.71 | 71.03 ± 22.80 |
This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD
| units on a scale | Group Based Exposure Therapy | Present Centered Group Therapy |
|---|---|---|
| Pre treatment | 145.45 ± 30.19 | 135.29 ± 35.22 |
| Post treatment | 130.07 ± 34.84 | 139.58 ± 40.52 |
| One yr post tx (N=35 GBET & N= 33 PCGT | 127.36 ± 40.48 | 140.57 ± 34.45 |
Collected over For the whole four years of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group Based Exposure Therapy | — | 0/41 (0%) | 0/41 (0%) |
| Present Centered Group Therapy | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Group Based Exposure Therapy | Present Centered Group Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 37 | 77 |
| >=65 years | 1 | 3 | 4 |
| Age, Continuous(years) | Group Based Exposure Therapy | Present Centered Group Therapy | Total |
|---|---|---|---|
| Mean | 61.41 (55 to 68) | 61.38 (55 to 69) | 61.40 (55 to 69) |
| Sex/Gender, Customized(participants) | Group Based Exposure Therapy | Present Centered Group Therapy | Total |
|---|---|---|---|
| Male | 41 | 40 | 81 |
| Region of Enrollment(participants) | Group Based Exposure Therapy | Present Centered Group Therapy | Total |
|---|---|---|---|
| United States | 41 | 40 | 81 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs