Overview

This trial is active, not recruiting.

Condition ptsd
Treatments mindfulness based cognitive behavioral conjoint therapy for ptsd, psychoeducation (control)
Sponsor Department of Veterans Affairs
Start date July 2010
End date June 2014
Trial size 205 participants
Trial identifier NCT01035788, 1001-02B, B7331-R

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
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)
Psychoeducational Intervention
psychoeducation (control)
This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD.

Primary Outcomes

Measure
PTSD symptoms, relationship functioning, anxiety and depression
time frame: All will be measured at 6 months following completion of the intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
Principal investigator Louanne Whitman Davis, PsyD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.