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CompletedNCT00535223Updated Mar 26, 2015Results posted

Group Based Exposure Therapy for Combat-Related PTSD

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

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Posttraumatic Stress Disorder

Keywords

  • Cognitive Behavior Therapy
  • Group therapy
  • Posttraumatic Stress Disorder
  • Randomized Controlled Trial
  • Treatment outcome
  • Veterans
  • War
03

In context

Stress Disorders, Traumatic

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 →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts 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.

Exclusion criteria

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.

  1. Patients with current or history of mania or schizophrenia would be excluded because the stress of exposure therapy may precipitate an increase in symptoms of these co-morbid conditions that could interfere with the patient's ability to benefit from treatment.
  2. Patients suffering from current active psychosis, active mania, or sufficient mental impairment, as assessed by a Mini Mental State Exam score below 24, which would prevent the patient from providing valid consent or participating safely or understanding the treatment.
  3. Patients with current, prominent suicidal ideation. All patients would be screened for suicidal ideation and intention by the RC in the initial screening and again by the IA in the initial assessment through a brief clinical interview. A BDI #9 score above 3 would prompt a more in-depth inquiry concerning suicidal thoughts and intentions during the initial assessment.
  4. Patients who currently meet diagnostic criteria for substance abuse or dependence or have met such criteria during the previous three months (as measured by the clinical interview and the Kreek-McHugh-Schluger-Kellogg scale (50)).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Group Based Exposure Therapy

    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

  • Experimental
    Present Centered Group 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

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.

  • BehavioralPresent Centered Group Therapy

    Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Mar 26, 2015

Participant flow

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.

Participant flow — Overall Study
MilestoneGroup Based Exposure TherapyPresent Centered Group Therapy
Started4140
Completed3739
Not completed41
Withdrew: Withdrawal by subject41

Outcome measures

PrimaryClinician 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
Reported as:
Mean · units on a scale
Clinician Administered PTSD Scale (CAPS)
units on a scaleGroup Based Exposure TherapyPresent Centered Group Therapy
Pre treatment82.4 ± 15.0981.18 ± 14.31
Post treatment[71.73 ± 20.5575.43 ± 23.01
one yr post tx (N= 35 GBET & N=33 PCGT69.29 ± 20.7171.03 ± 22.80
SecondaryPosttraumatic 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
Reported as:
Mean · units on a scale
Posttraumatic Cognitions Inventory (PTCI)
units on a scaleGroup Based Exposure TherapyPresent Centered Group Therapy
Pre treatment145.45 ± 30.19135.29 ± 35.22
Post treatment130.07 ± 34.84139.58 ± 40.52
One yr post tx (N=35 GBET & N= 33 PCGT127.36 ± 40.48140.57 ± 34.45

Adverse events

Collected over For the whole four years of the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group Based Exposure Therapy—0/41 (0%)0/41 (0%)
Present Centered Group Therapy—0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group Based Exposure TherapyPresent Centered Group TherapyTotal
<=18 years000
Between 18 and 65 years403777
>=65 years134
Age, Continuous
Age, Continuous(years)Group Based Exposure TherapyPresent Centered Group TherapyTotal
Mean61.41 (55 to 68)61.38 (55 to 69)61.40 (55 to 69)
Sex/Gender, Customized
Sex/Gender, Customized(participants)Group Based Exposure TherapyPresent Centered Group TherapyTotal
Male414081
Region of Enrollment
Region of Enrollment(participants)Group Based Exposure TherapyPresent Centered Group TherapyTotal
United States414081
08

Study locations

1 site
  • VA Medical Center, Decatur
    Decatur, Georgia 30033, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00535223
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Sep 26, 2007
Start date
Jul 2007
Primary completion
Jul 2010
Completion
Aug 2012
Results posted
Mar 26, 2015
Last update
Mar 26, 2015

Study contacts

David Ready, PhD MS
principal investigator · VA Medical Center, Decatur

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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