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Effectiveness of Cognitive Behavioral Couples Therapy for Post-Traumatic Stress Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), January 2009
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

MedlinePlus related topics: Post-Traumatic Stress Disorder
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyadic Adjustment Scale [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]

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.

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Current diagnosis of PTSD
  • An intimate partner willing to participate in treatment

Exclusion Criteria:

  • Both partners have PTSD
  • Either partner with substance dependence not in remission for at least 3 months before study entry, current uncontrolled bipolar or psychotic disorder, or severe cognitive impairment
  • Couple currently experiencing severe intimate aggression or a desire to separate or end their intimate relationship
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669981

Contacts
Contact: Steffany J. Fredman, PhD 857-364-5678 Steffany.Fredman@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: Candice M. Monson, PhD VA Boston Healthcare System
  More Information

Study website  This link exits the ClinicalTrials.gov site

Publications:
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: January 22, 2009
ClinicalTrials.gov Identifier: NCT00669981  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
PTSD
Relationship Distress
Couple Therapy

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009