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

Post-traumatic Stress Disorder Clinical Trial

Official title:

Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669981
• Other study ID #: R34MH076813
• Secondary ID: R34MH076813DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 29, 2008
• Last updated: November 22, 2013
• Start date: August 2008
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Ryerson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Ryerson University	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Monson CM, Fredman SJ, Adair KC. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: application to operation enduring and Iraqi Freedom veterans. J Clin Psychol. 2008 Aug;64(8):958-71. doi: 10.1002/jclp.20511. — View Citation

Monson CM, Schnurr PP, Stevens SP, Guthrie KA. Cognitive-Behavioral Couple's Treatment for posttraumatic stress disorder: initial findings. J Trauma Stress. 2004 Aug;17(4):341-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale		Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up	No
Secondary	Dyadic Adjustment Scale		Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up	No