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

NCT ID: NCT00669981

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-traumatic Stress Disorder

Keywords

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PTSD Relationship Distress Couple Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive immediate cognitive behavioral couples therapy for PTSD.

Group Type EXPERIMENTAL

Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)

Intervention Type BEHAVIORAL

CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.

2

Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)

Intervention Type BEHAVIORAL

CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Candice Monson

Professor & Director of Clinical Training

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Candice M. Monson, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

Ryerson University

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1023/B:JOTS.0000038483.69570.5b.

Reference Type BACKGROUND
PMID: 15462542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18613094 (View on PubMed)

Monson CM, Fredman SJ, Macdonald A, Pukay-Martin ND, Resick PA, Schnurr PP. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):700-9. doi: 10.1001/jama.2012.9307.

Reference Type DERIVED
PMID: 22893167 (View on PubMed)

Other Identifiers

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R34MH076813

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

R34MH076813

Identifier Type: NIH

Identifier Source: org_study_id

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