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Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy (MB-CBCT) on Post-Traumatic Stress Disorder (PTSD) and Relationship Function

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01035788
First received: December 17, 2009
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to develop a treatment intervention which combines mindfulness meditation with cognitive behavioral therapy for PTSD to be taught to veterans diagnosed with PTSD and their partners. This study will examine the effects of this integrated intervention on PTSD symptoms and intimate relationship functioning of Operation Enduring and Iraqi Freedom Veterans.


Condition Intervention
PTSD
Behavioral: Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Behavioral: Psychoeducation (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD symptoms, relationship functioning, anxiety and depression [ Time Frame: All will be measured at 6 months following completion of the intervention ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: October 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Behavioral: Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, 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.
Active Comparator: Arm 2
Psychoeducational Intervention
Behavioral: Psychoeducation (control)
This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD.

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, 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 Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT for PTSD) on PTSD symptoms and intimate relationship functioning of veterans returning from Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF). 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. The integrated intervention, MB-CBCT for PTSD, will be delivered to 10 OIF-OEF veterans and their intimate partners in order to develop and test procedures to train and monitor therapists. During Phase 2, a randomized controlled trial with 40 OEF-OIF veteran couples will be conducted comparing the MB-CBCT for PTSD with a control condition that teaches communication skills. We hypothesize that MB-CBCT for PTSD will lead to greater improvement in: 1) veterans' PTSD symptoms; 2) veterans' and partners' relationship functioning; and 3) anxiety and depression symptoms. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  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: NCT01035788

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Investigators
Principal Investigator: Louanne Whitman Davis, PsyD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01035788     History of Changes
Other Study ID Numbers: B7331-R, 1001-02B
Study First Received: December 17, 2009
Last Updated: November 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
mindfulness meditation
cognitive behavior therapy
couples therapy
relationship function

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

ClinicalTrials.gov processed this record on November 24, 2014