Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 19, 2008 | ||||
| Last Updated Date | November 20, 2008 | ||||
| Start Date ICMJE | November 2008 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anxiety Sensitivity Index-3 [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00795379 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy | ||||
| Official Title ICMJE | Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Anxiety | ||||
| Intervention ICMJE | Behavioral: Interoceptive Exposure
Exposure to internal stimuli. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00795379 | ||||
| Other Study ID Numbers ICMJE | MIRECC 5-1006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kevin S. Del Ben, Ph.D. Assistant Professor, G.V. (Sonny) Montgomery VA Medical Center | ||||
| Study Sponsor ICMJE | G.V. (Sonny) Montgomery VA Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | G.V. (Sonny) Montgomery VA Medical Center | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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