View Clinical Trial (Medical Research Study)
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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PTSD |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01035788 |
| Primary Contact: |
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Principal Investigator
Louanne Whitman Davis, PsyD
Richard Roudebush VA Medical Center, Indianapolis
Louanne W Davis, PsyD
Phone: (317) 988-4523
Email: Louanne.davis@va.gov
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| Backup Contact: |
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Email: Amanda.Eicher@va.gov
Amanda C Eicher, BS
Phone: (317) 988-2164
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| Location Contact: |
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Indianapolis, Indiana 46202
United States
Louanne W Davis, PsyD
Phone: (317) 988-4523
Email: Louanne.davis@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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