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Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Behavioral Conjoint Therapy
CBCT for PTSD - Communication Skills
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, mindfulness meditation, cognitive behavior therapy, relationship function, couple therapy

Eligibility Criteria

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

Inclusion Criteria:

Veteran must:

  • be enrolled in outpatient treatment
  • have a confirmed diagnosis of PTSD
  • have no major change in psychiatric medication for at least 1 month
  • have a partner mutually committed to maintaining the relationship for the duration of the intervention
  • willing to forgo initiating psychotherapy for PTSD or other conditions during the study

Exclusion Criteria:

  • severe physical or sexual relationship aggression in the past year
  • current suicidal/homicidal intent (Veteran or partner)
  • cognitive impairment that precludes understanding session content (either Veteran or partner)
  • current substance dependence of Veteran or partner
  • uncontrolled psychotic or bipolar disorder in Veteran or partner
  • PTSD diagnosis in the partner
  • self-mutilation or self-injury within the previous 6 months by Veteran or partner
  • unwilling to have therapy or CAPS sessions video or audio recorded

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based CBCT

CBCT Communication Skills

Arm Description

Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD

CBCT for PTSD - Communication Skills

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale (CAPS)
The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
October 3, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01035788
Brief Title
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
Official Title
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2010 (Actual)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1) reducing the overall length of treatment from 15 weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as a way to mitigate the short, more condensed treatment. Secondly, this study will examine the effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD symptoms and intimate relationship functioning.
Detailed Description
Between 5 and 15 percent of Veterans return from deployment in Iraq and Afghanistan with PTSD and the symptoms adversely affect many aspects of their lives, including intimate relationships. Although research findings consistently suggest that the degree of intimate relationship dysfunction correlates with the severity of Veteran's PTSD symptoms, few couples interventions have been developed and systematically evaluated. Cognitive Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) is an intervention developed to treat both PTSD and relationship dysfunction that has shown promising preliminary results. However, the literature suggests that OEF-OIF Veterans prefer shorter time-limited treatments and CBCT for PTSD requires as many as 15 sessions. CBCT for PTSD lacks specific interventions that train meta-awareness, such as those taught in mindfulness-based stress reduction (MBSR). Mindfulness practices have an emerging evidence base for improving both PTSD and relationship functioning in several important ways. First, practicing mindfulness promotes the relaxation response which counters hyperarousal and results in a calmer approach to difficulties and challenges. Second, avoidance and numbing are countered by mindfully allowing one's experience to be as it is while suspending judgment, which is associated with increased compassion and empathy. Lastly, mindfulness supports a way of being with all life experiences rather than providing techniques just for coping with specific difficulties, which enables individuals to access inner strengths that are already available to them. Just as many physical conditions require more than one rehabilitation approach, there may be a synergy between CBCT for PTSD and mindfulness interventions. Mindfulness skills may assist individuals in tolerating painful emotional reactions to their experiences which may in turn enhance their awareness of associated feelings and thoughts. With enhanced meta-awareness the beliefs that may maintain PTSD symptoms and relationship dysfunction become more amenable to cognitive restructuring. Therefore, the goal of this study is to examine the effects of a Mindfulness-Based adaptation of CBCT for PTSD. The study involves two phases over the course of four years. In Phase 1, mindfulness interventions will be integrated within the Cognitive Behavioral Conjoint Therapy for PTSD treatment manual and the content of the first 7 sessions of CBCT will be adapted to be delivered during a weekend retreat. The integrated intervention, MB-CBCT for PTSD, will be delivered to 10 OIF-OEF Veterans and each of their intimate partners in order to develop and test procedures to train and monitor therapists. During Phase 2, 40 OEF-OIF Veterans and each of their intimate partners will be consented and a randomized controlled trial with be conducted comparing the MB-CBCT for PTSD with a control condition that teaches communication skills drawn from the first 7 sessions of the CBCT manual. We hypothesize that MB-CBCT for PTSD will lead to greater improvement in: 1) Veterans' PTSD symptoms as measured by the Clinician Administered PTSD Scale (primary outcome) and PTSD Checklist (secondary outcome); 2) Veterans' and partners' relationship functioning (secondary outcome); and 3) anxiety and depression symptoms (secondary outcomes). PTSD constitutes a substantial proportion of the burden of illness among Veterans. The longer term goals of this project are to conduct a fully-powered randomized controlled clinical trial of MB-CBCT to determine its effectiveness and to finalize the treatment manual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, mindfulness meditation, cognitive behavior therapy, relationship function, couple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based CBCT
Arm Type
Experimental
Arm Description
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Arm Title
CBCT Communication Skills
Arm Type
Active Comparator
Arm Description
CBCT for PTSD - Communication Skills
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Behavioral Conjoint Therapy
Intervention Description
This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses.
Intervention Type
Behavioral
Intervention Name(s)
CBCT for PTSD - Communication Skills
Intervention Description
This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Description
The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.
Time Frame
treatment end (approximately 10 weeks after session 1 of the interventions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran must: be enrolled in outpatient treatment have a confirmed diagnosis of PTSD have no major change in psychiatric medication for at least 1 month have a partner mutually committed to maintaining the relationship for the duration of the intervention willing to forgo initiating psychotherapy for PTSD or other conditions during the study Exclusion Criteria: severe physical or sexual relationship aggression in the past year current suicidal/homicidal intent (Veteran or partner) cognitive impairment that precludes understanding session content (either Veteran or partner) current substance dependence of Veteran or partner uncontrolled psychotic or bipolar disorder in Veteran or partner PTSD diagnosis in the partner self-mutilation or self-injury within the previous 6 months by Veteran or partner unwilling to have therapy or CAPS sessions video or audio recorded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louanne Whitman Davis, PsyD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function

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