Trial Outcomes & Findings for A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD) (NCT NCT00984698)

Last Updated: 2014-03-31

Results Overview

Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

post-treatment, at 12 weeks

Results posted on

2014-03-31

Participant Flow

Veterans were recruited from the Southern Arizona VA Health Care System, Mental Health Clinic, September 2009 to July 2011.

115 enrolled, 50 eligible, 7 withdrew prior to randomization (3 time commitment, 2 lost contact, 1 changed mind/unknown, 1 travel distance)

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Social Rhythm Group Therapy CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	Present Centered Group Therapy PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Overall Study STARTED	21	22
Overall Study COMPLETED	18	14
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Social Rhythm Group Therapy n=21 Participants CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	Present Centered Group Therapy n=22 Participants PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.	Total n=43 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	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.24 years STANDARD_DEVIATION 13.99 • n=5 Participants	51.46 years STANDARD_DEVIATION 12.60 • n=7 Participants	48.42 years STANDARD_DEVIATION 13.51 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: post-treatment, at 12 weeks

Population: CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Social Rhythm Group Therapy n=20 Participants CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	Present Centered Group Therapy n=17 Participants PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Depression	20.30 units on a scale Standard Deviation 6.51	19.18 units on a scale Standard Deviation 5.79

SECONDARY outcome

Timeframe: post-treatment, at 12 weeks

Population: CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment

Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Social Rhythm Group Therapy n=20 Participants CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	Present Centered Group Therapy n=17 Participants PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
PTSD	67.35 units on a scale Standard Deviation 26.82	62.47 units on a scale Standard Deviation 24.83

Adverse Events

Cognitive Behavioral Social Rhythm Group 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

Dr. Patricia Haynes, Assistant Professor

University of Arizona

Phone: 5206261855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place