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

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, Relationship Distress, Couple Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Boston Healthcare System
  • Ryerson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive immediate cognitive behavioral couples therapy for PTSD.

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

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale

Secondary Outcome Measures

Dyadic Adjustment Scale

Full Information

First Posted
April 29, 2008
Last Updated
November 22, 2013
Sponsor
Toronto Metropolitan University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00669981
Brief Title
Effectiveness of Cognitive Behavioral Couples Therapy for Post-traumatic Stress Disorder
Official Title
Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
PTSD, Relationship Distress, Couple Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive immediate cognitive behavioral couples therapy for PTSD.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)
Intervention Description
CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale
Time Frame
Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up
Secondary Outcome Measure Information:
Title
Dyadic Adjustment Scale
Time Frame
Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice M. Monson, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15462542
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. doi: 10.1023/B:JOTS.0000038483.69570.5b.
Results Reference
background
PubMed Identifier
18613094
Citation
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.
Results Reference
background
PubMed Identifier
22893167
Citation
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.
Results Reference
derived

Learn more about this trial

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

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