Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Cognitive Behavioral Couples Therapy for Post-Traumatic Stress Disorder
This study is currently recruiting participants.
Study NCT00669981   Information provided by National Institute of Mental Health (NIMH)
First Received: April 29, 2008   Last Updated: March 10, 2009   History of Changes

April 29, 2008
March 10, 2009
August 2008
June 2010   (final data collection date for primary outcome measure)
Clinician-Administered PTSD Scale [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Clinician-Administered PTSD Scale [ Time Frame: Measured at pretreatment, midtreatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669981 on ClinicalTrials.gov Archive Site
Dyadic Adjustment Scale [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Dyadic Adjustment Scale [ Time Frame: Measured at pretreatment, midtreatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
 
Effectiveness of Cognitive Behavioral Couples Therapy for Post-Traumatic Stress Disorder
Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder

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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study
Post-Traumatic Stress Disorder
Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
  • Experimental: Participants will receive immediate cognitive behavioral couples therapy for PTSD.
  • Active Comparator: Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Steffany J. Fredman, PhD 857-364-5678 Steffany.Fredman@va.gov
United States
 
NCT00669981
Candice M. Monson, PhD, VA Boston Healthcare System
R34 MH076813, DSIR 83-ATAS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Candice M. Monson, PhD VA Boston Healthcare System
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP