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Effectiveness of Cognitive Behavioral Couples Therapy for Post-traumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00669981
First received: April 29, 2008
Last updated: June 12, 2012
Last verified: November 2010
History of Changes

April 29, 2008
June 12, 2012
August 2008
June 2012   (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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Post-traumatic Stress Disorder
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.
  • Experimental: 1
    Participants will receive immediate cognitive behavioral couples therapy for PTSD.
    Intervention: Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
  • Active Comparator: 2
    Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.
    Intervention: Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2012
June 2012   (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 information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00669981
R34 MH076813, DSIR 83-ATAS
No
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
 
Principal Investigator: Candice M. Monson, PhD Ryerson University
National Institute of Mental Health (NIMH)
November 2010

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