Group Based Exposure Therapy for Combat-Related PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00535223
First received: September 24, 2007
Last updated: March 23, 2015
Last verified: March 2015
Results First Received: December 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Posttraumatic Stress Disorder
Interventions: Behavioral: Group Based Exposure Therapy
Behavioral: Present Centered Group Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Group Based Exposure Therapy     Present Centered Group Therapy  
STARTED     41 [1]   40 [1]
COMPLETED     37     39  
NOT COMPLETED     4     1  
Withdrawal by Subject                 4                 1  
[1] Patients were randomized in cohorts of ten.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Group Based Exposure Therapy     Present Centered Group Therapy     Total  
Number of Participants  
[units: participants]
  41     40     81  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     37     77  
>=65 years     1     3     4  
Age  
[units: years]
Mean (Full Range)
  61.41  
  (55 to 68)  
  61.38  
  (55 to 69)  
  61.40  
  (55 to 69)  
Gender, Customized  
[units: participants]
     
Male     41     40     81  
Region of Enrollment  
[units: participants]
     
United States     41     40     81  



  Outcome Measures
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1.  Primary:   Clinician Administered PTSD Scale (CAPS)   [ Time Frame: Pre treatment, Post treatment (16 weeks) and One year post treatment ]

2.  Secondary:   Posttraumatic Cognitions Inventory (PTCI)   [ Time Frame: Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David J. Ready,Ph.D.
Organization: Atlanta VA Medical Center
phone: (404) 321-6111 ext 7082
e-mail: David.Ready@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00535223     History of Changes
Other Study ID Numbers: MHBA-010-06F
Study First Received: September 24, 2007
Results First Received: December 22, 2014
Last Updated: March 23, 2015
Health Authority: United States: Federal Government