Trial record 3 of 342 for:
"Sleep Initiation and Maintenance Disorders"
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Arizona
Collaborators:
Southern Arizona VA Health Care System
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00984698
First received: September 24, 2009
Last updated: August 9, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder Depression Sleep Initiation and Maintenance Disorders (i.e. Insomnia) |
Behavioral: Structured group therapy Behavioral: Unstructured Group Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD) |
Resource links provided by NLM:
Further study details as provided by University of Arizona:
Primary Outcome Measures:
- Insomnia, Nightmares, and Other Mental Health Symptoms [ Time Frame: 12 week group therapy, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 76 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Behavioral: Structured group therapy
One therapy is a highly structured, integrative cognitive behavioral therapy administered in a group format. The group meets once per week for 12 weeks. Each session is 2 hours. Discussion of traumatic events is minimized, but not avoided.
Behavioral: Unstructured Group Therapy
In the unstructured condition, patients discuss current problems, with group process as a primary focus. The group meets once per week for 12 weeks and last for 2 hours. Discussion of past traumatic experiences is minimized, but not avoided.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984698
Locations
| United States, Arizona | |
| Southern Arizona VA Healthcare System (SAVAHCS) | |
| Tucson, Arizona, United States, 85723 | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
Sponsors and Collaborators
University of Arizona
Southern Arizona VA Health Care System
Investigators
| Principal Investigator: | Patricia Haynes, PhD | University of Arizona |
More Information
Additional Information:
No publications provided
| Responsible Party: | Patricia Haynes, PhD (Principal Investigator), Southern Arizona VA Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00984698 History of Changes |
| Other Study ID Numbers: | W81XWH-08-2-0121 |
| Study First Received: | September 24, 2009 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Arizona:
|
Posttraumatic Stress Disorder Depression Sleep Initiation and Maintenance Disorders Insomnia Psychotherapy, Group |
Cognitive Behavioral Therapy Randomized Controlled Trial Veterans Social Rhythms |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Behavioral Symptoms Mood Disorders |
Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Anxiety Disorders |
ClinicalTrials.gov processed this record on May 16, 2013