Back to resultsA Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Posttraumatic Stress Disorder, Depression, Insomnia Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Social Rhythm Group Therapy
Present Centered Group Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Depression, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans, Social Rhythms
Eligibility Criteria
Inclusion Criteria:
- Veteran or active duty military personnel
- Current posttraumatic stress disorder (PTSD), at least moderate severity
- Criterion A exposure to trauma occurring after the age of 18
- Major depressive disorder (MDD), at least moderate severity
- Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine
Exclusion Criteria:
- Current or past bipolar disorder
- Current psychotic disorder
- Substance abuse/dependence in last 30 days
- Uncontrolled serious medical condition or neurological disorder
- Currently working an overnight shift
- Primary untreated sleep apnea, restless legs syndrome
Sites / Locations
- Southern Arizona VA Healthcare System (SAVAHCS)
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Structured Therapy
Unstructured Therapy
Arm Description
Cognitive Behavioral Social Rhythm Group Therapy 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 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.
Outcomes
Primary Outcome Measures
Depression
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).
Secondary Outcome Measures
PTSD
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).
Full Information
NCT ID
NCT00984698
First Posted
September 24, 2009
Last Updated
February 14, 2014
Sponsor
University of Arizona
Collaborators
United States Department of Defense, Southern Arizona VA Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT00984698
Brief Title
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
Official Title
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
United States Department of Defense, Southern Arizona VA Health Care System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.
Detailed Description
The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression, Insomnia Disorder
Keywords
Posttraumatic Stress Disorder, Depression, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans, Social Rhythms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured Therapy
Arm Type
Experimental
Arm Description
Cognitive Behavioral Social Rhythm Group Therapy 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.
Arm Title
Unstructured Therapy
Arm Type
Active Comparator
Arm Description
Present Centered Group Therapy 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Rhythm Group Therapy
Intervention Description
12 weeks, 2h structured group therapy
Intervention Type
Behavioral
Intervention Name(s)
Present Centered Group Therapy
Intervention Description
12 weeks, 2h relatively unstructured group therapy
Primary Outcome Measure Information:
Title
Depression
Description
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).
Time Frame
post-treatment, at 12 weeks
Secondary Outcome Measure Information:
Title
PTSD
Description
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).
Time Frame
post-treatment, at 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran or active duty military personnel
Current posttraumatic stress disorder (PTSD), at least moderate severity
Criterion A exposure to trauma occurring after the age of 18
Major depressive disorder (MDD), at least moderate severity
Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine
Exclusion Criteria:
Current or past bipolar disorder
Current psychotic disorder
Substance abuse/dependence in last 30 days
Uncontrolled serious medical condition or neurological disorder
Currently working an overnight shift
Primary untreated sleep apnea, restless legs syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Haynes, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Healthcare System (SAVAHCS)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33065820
Citation
Haynes PL, Burger SB, Kelly M, Emert S, Perkins S, Shea MT. Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial. J Affect Disord. 2020 Dec 1;277:800-809. doi: 10.1016/j.jad.2020.09.009. Epub 2020 Sep 7.
Results Reference
derived
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A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
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