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Group Based Exposure Therapy for Combat-Related PTSD

Group Based Exposure Therapy for Combat PTSD: RCT and Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00535223
Enrollment
81
Registered
2007-09-26
Start date
2007-07-31
Completion date
2012-08-31
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Cognitive Behavior Therapy, Group therapy, Posttraumatic Stress Disorder, Randomized Controlled Trial, Treatment outcome, Veterans, War

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALGroup Based Exposure 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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

1. Male veterans diagnosed with war-related PTSD as assessed by the CAPS. Patients must provide a DD214 or other documentation of war exposure. 2. Patients must have the ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments (as evident by the ability to pass informed consent test, to fill out self-report assessment measures and to respond appropriately during the clinical interview). 3. Patients must be either stable on psychotropic medication (defined as no additional psychotropic medications or significant increases in previously prescribed psychotropic medications for a period of at least three months) or not on psychotropic medication. 4. Patients must be currently in treatment within the Mental Health Clinic (MHC) of the Atlanta VA Medical Center for a minimum of four months prior to participation. This would insure adequate psychiatric coverage and case management. If a change in medication were needed during the study, it would be made. Such changes would be tracked for analysis if they occur in a significant number of patients. 5. Patients must have the support of their current Mental Health Clinic Treatment Team to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale (CAPS)Pre treatment, Post treatment (16 weeks) and One year post treatmentThis 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.

Secondary

MeasureTime frameDescription
Posttraumatic Cognitions Inventory (PTCI)Pre-treatment, Post-Treatment (16 weeks) and One year Post TreatmentThis 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

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Participants had been referred to an outpatient PTSD program, were first screened by the staff of that program and if judged to be appropriate for intensive PTSD treatment were informed about the study. They could request to be screened for the study or go directly into one of the treatments provided by the PTSD program.

Participants by arm

ArmCount
Group Based Exposure Therapy
Group Based Exposure 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.
41
Present Centered Group Therapy
Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus.
40
Total81

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject41

Baseline characteristics

CharacteristicGroup Based Exposure TherapyPresent Centered Group TherapyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants3 Participants4 Participants
Age, Categorical
Between 18 and 65 years
40 Participants37 Participants77 Participants
Age, Continuous61.41 years61.38 years61.40 years
Region of Enrollment
United States
41 participants40 participants81 participants
Sex/Gender, Customized
Male
41 participants40 participants81 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 410 / 40
serious
Total, serious adverse events
0 / 410 / 40

Outcome results

Primary

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

Population: Pre-tx Post-tx 1-yr F.U. N M SD Range N M SD Range N M SD Range GBET 41 82.44 15.09 55-107 41 71.73 20.55 34-105 35 69.29 20.71 24-107 PCGT 40 81.18 14.31 52-109 40 75.43 23.01 18-122 33 71.03 22.80 37-121

ArmMeasureGroupValue (MEAN)Dispersion
Group Based Exposure TherapyClinician Administered PTSD Scale (CAPS)Post treatment[71.73 units on a scaleStandard Deviation 20.55
Group Based Exposure TherapyClinician Administered PTSD Scale (CAPS)one yr post tx (N= 35 GBET & N=33 PCGT69.29 units on a scaleStandard Deviation 20.71
Group Based Exposure TherapyClinician Administered PTSD Scale (CAPS)Pre treatment82.4 units on a scaleStandard Deviation 15.09
Present Centered Group TherapyClinician Administered PTSD Scale (CAPS)one yr post tx (N= 35 GBET & N=33 PCGT71.03 units on a scaleStandard Deviation 22.8
Present Centered Group TherapyClinician Administered PTSD Scale (CAPS)Pre treatment81.18 units on a scaleStandard Deviation 14.31
Present Centered Group TherapyClinician Administered PTSD Scale (CAPS)Post treatment[75.43 units on a scaleStandard Deviation 23.01
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Group Based Exposure TherapyPosttraumatic Cognitions Inventory (PTCI)Pre treatment145.45 units on a scaleStandard Deviation 30.19
Group Based Exposure TherapyPosttraumatic Cognitions Inventory (PTCI)Post treatment130.07 units on a scaleStandard Deviation 34.84
Group Based Exposure TherapyPosttraumatic Cognitions Inventory (PTCI)One yr post tx (N=35 GBET & N= 33 PCGT127.36 units on a scaleStandard Deviation 40.48
Present Centered Group TherapyPosttraumatic Cognitions Inventory (PTCI)Pre treatment135.29 units on a scaleStandard Deviation 35.22
Present Centered Group TherapyPosttraumatic Cognitions Inventory (PTCI)Post treatment139.58 units on a scaleStandard Deviation 40.52
Present Centered Group TherapyPosttraumatic Cognitions Inventory (PTCI)One yr post tx (N=35 GBET & N= 33 PCGT140.57 units on a scaleStandard Deviation 34.45

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026