Trial Outcomes & Findings for Group Based Exposure Therapy for Combat-Related PTSD (NCT NCT00535223)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

Pre treatment, Post treatment (16 weeks) and One year post treatment

Results posted on

2015-03-26

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	41	40
Overall Study COMPLETED	37	39
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

Group Based Exposure Therapy for Combat-Related PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Based Exposure Therapy n=41 Participants 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 n=40 Participants Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	61.41 years n=5 Participants	61.38 years n=7 Participants	61.40 years n=5 Participants
Sex/Gender, Customized Male	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group Based Exposure Therapy n=41 Participants See below 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 n=40 Participants The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
Clinician Administered PTSD Scale (CAPS) Pre treatment	82.4 units on a scale Standard Deviation 15.09	81.18 units on a scale Standard Deviation 14.31
Clinician Administered PTSD Scale (CAPS) Post treatment[	71.73 units on a scale Standard Deviation 20.55	75.43 units on a scale Standard Deviation 23.01
Clinician Administered PTSD Scale (CAPS) one yr post tx (N= 35 GBET & N=33 PCGT	69.29 units on a scale Standard Deviation 20.71	71.03 units on a scale Standard Deviation 22.80

SECONDARY outcome

Timeframe: Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment

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

Outcome measures

Outcome measures
Measure	Group Based Exposure Therapy n=41 Participants See below 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 n=40 Participants The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
Posttraumatic Cognitions Inventory (PTCI) Pre treatment	145.45 units on a scale Standard Deviation 30.19	135.29 units on a scale Standard Deviation 35.22
Posttraumatic Cognitions Inventory (PTCI) Post treatment	130.07 units on a scale Standard Deviation 34.84	139.58 units on a scale Standard Deviation 40.52
Posttraumatic Cognitions Inventory (PTCI) One yr post tx (N=35 GBET & N= 33 PCGT	127.36 units on a scale Standard Deviation 40.48	140.57 units on a scale Standard Deviation 34.45

Adverse Events

Group Based Exposure Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Present Centered Group Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David J. Ready,Ph.D.

Atlanta VA Medical Center

Phone: (404) 321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place