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Sponsored by: |
G.V. (Sonny) Montgomery VA Medical Center |
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Information provided by: | G.V. (Sonny) Montgomery VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00795379 |
To assess the effectiveness of Interoceptive Exposure (IE) as a treatment to reduce negative cognitions and arousal in a veteran sample during an anxiety-inducing situation (i.e., the Trier Social Stressor Task - an analogue to the anxiety of undergoing exposure-based treatment). After completing the initial screening, qualifying participants will complete a pre-intervention assessment at UMC (structured clinical interview, self-report measures, and a treatment-engagement analogue exercise). Half of the participants will be randomized into either supportive counseling or to the treatment protocol at GVSMVAMC consisting of four sessions of Interoceptive Exposure over a four week period targeting interoceptive stimuli. Veterans will be assessed a second time at UMC after treatment (5 to 6 weeks after the first assessment). Participants will include approximately 40 male OEF/OIF veterans with combat-related PTSD recruited from the Trauma Recovery Program (TRP) and Post-deployment Clinic at the G.V. (Sonny) Montgomery VAMC (GVSMVAMC). Following the pre-intervention assessment, veterans will be randomized into one of two groups. Half of the veterans (n = 20) will receive received four weeks of supportive counseling while the other half will receive four weeks of Interoceptive Exposure (IE). The proposed study examines anxiety sensitivity (AS) as a possible barrier to treatment engagement in exposure therapy for PTSD. AS is a dispositional cognitive characteristic defined as the fear of sensations directly related to autonomic arousal that arises from the belief that these sensations have harmful consequences. Interoceptive Exposure (IE) is an intervention that: 1) helps individuals with high AS increase their tolerance to the somatic sensations of arousal; and 2) promotes an adaptive appraisal of fear-related sensations The current study will use a social stressor task to assess the affect of IE on AS and avoidance among veterans who have PTSD, thereby increasing the likelihood that a veteran will enter into, and remain in, treatment for PTSD.
Condition | Intervention |
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Anxiety |
Behavioral: Interoceptive Exposure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IE: Experimental
Participants will complete an at home four-week, intervention targeting their negative cognitions triggered by physical sensations. The goal of IE is to purposefully induce bodily sensations related to autonomic arousal so that participants can learn that those sensations are not harmful. IE and Cognitive restructuring have been found to be superior to progressive muscle relaxation as a way to avoid aversive autonomic sensations.
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Behavioral: Interoceptive Exposure
Exposure to internal stimuli.
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2: No Intervention
waitlist control
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kevin S Del Ben, Ph.D. | 601-984-5807 | kdelben@psychiatry.umsmed.edu |
United States, Mississippi | |
G.V. (Sonny) Montgomery VAMC | Recruiting |
Jackson, Mississippi, United States, 39216 | |
Contact: Kevin S Del Ben, Ph.D. 601-984-5807 kdelben@psychiatry.umsmed.edu |
Responsible Party: | G.V. (Sonny) Montgomery VA Medical Center ( Kevin S. Del Ben, Ph.D. Assistant Professor ) |
Study ID Numbers: | MIRECC 5-1006 |
Study First Received: | November 19, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795379 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Psychotherapy |