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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Candice Monson, Ryerson University
ClinicalTrials.gov Identifier:
NCT00669981
First received: April 29, 2008
Last updated: November 22, 2013
Last verified: November 2013
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Ryerson University:

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 ]

Enrollment: 80
Study Start Date: August 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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 mid-treatment, end of treatment, and 3 months after the end of treatment. Participants receiving delayed treatment will undergo assessments 1 and 3 months into the wait-list 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 wait-list 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669981

Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Canada, Ontario
Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
Investigators
Principal Investigator: Candice M. Monson, PhD Ryerson University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Candice Monson, Professor & Director of Clinical Training, Ryerson University
ClinicalTrials.gov Identifier: NCT00669981     History of Changes
Other Study ID Numbers: R34 MH076813, R34MH076813, DSIR 83-ATAS
Study First Received: April 29, 2008
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Ryerson University:
PTSD
Relationship Distress
Couple Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014