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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00669981 |
Purpose
This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorder |
Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder |
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive immediate cognitive behavioral couples therapy for PTSD.
|
Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.
|
|
2: Active Comparator
Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.
|
Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.
|
Post-traumatic stress disorder (PTSD) is a highly prevalent and disabling disorder that affects about 7.7 million adults in the United States. PTSD can develop after someone experiences a particularly distressing event that may involve the threat of or actual physical harm. Common symptoms of PTSD include avoidance of situations or cues that may act as reminders of the event, reoccurring flashbacks of the event, loss of interest in previously enjoyed activities, and numbing of emotions. Additionally, PTSD is often associated with far-reaching and devastating interpersonal relationship problems that can maintain or aggravate other PTSD symptoms. These interpersonal problems can also interfere with successful treatment delivery, so addressing such problems is important for improving treatment compliance, effectiveness, and long-term success. Cognitive behavioral therapy (CBT) is a type of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to PTSD. CBT that is adapted for couples in which one partner has PTSD may be the most effective means of decreasing individual PTSD symptoms and improving the couple's relationship. This study will evaluate the effectiveness of cognitive behavioral couples therapy (CBCT) for PTSD in reducing symptoms of PSTD and in improving relationship functioning for couples in which one partner has PTSD.
Participation in this study will last 8 months. All participants will undergo baseline assessments that will include an interview about exposure to traumatic events, PTSD symptoms, mental health problems, and substance use; self-report questionnaires about mood, social and leisure activities, and relationships; and a brief video-recorded communication session as a couple. Eligible participants will then be assigned randomly to receive immediate CBCT for PTSD or delayed CBCT for PTSD. Participants in the delayed treatment group will receive active treatment after a 3-month waitlist period. CBCT for PTSD will include fifteen 75-minute couples therapy sessions, occurring twice weekly for 3 weeks and weekly for the remaining 9 weeks of treatment.
Sessions will follow manual-based couples therapy and will aim to both decrease individual PTSD symptoms and enhance dyadic functioning. After each session, participants will also complete out-of-session practice assignments that will include completing worksheets and practicing skills taught in therapy sessions.
Participants receiving immediate CBCT for PTSD will undergo subsequent assessments at midtreatment, end of treatment, and 3 months after the end of treatment. Participants receiving delayed treatment will undergo assessments 1 and 3 months into the waitlist period and at the end of treatment.
Assessments will include questions about PTSD and mental health symptoms, alcohol and substance use, intimate relationship functioning, and family and social activities. Participants will repeat the communication session after the end of treatment for the group receiving immediate therapy and at the end of the waitlist period for the delayed treatment group.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Steffany J. Fredman, PhD | 857-364-5678 | Steffany.Fredman@va.gov |
| United States, Massachusetts | |
| VA Boston Healthcare System | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Principal Investigator: | Candice M. Monson, PhD | VA Boston Healthcare System |
More Information
| Responsible Party: | VA Boston Healthcare System ( Candice M. Monson, PhD ) |
| Study ID Numbers: | R34 MH076813, DSIR 83-ATAS |
| Study First Received: | April 29, 2008 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00669981 History of Changes |
| Health Authority: | United States: Federal Government |
|
PTSD Relationship Distress Couple Therapy |
|
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
|
Pathologic Processes Disease Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |