Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy

Anxiety Clinical Trial

Official title:

Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00795379
• Other study ID #: MIRECC 5-1006
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2008
• Last updated: November 20, 2008
• Start date: November 2008

Study information

• Verified date: November 2008
• Source: G.V. (Sonny) Montgomery VA Medical Center
• Contact: Kevin S Del Ben, Ph.D.
• Phone: 601-984-5807
• Email: kdelben[@]psychiatry.umsmed.edu
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Interested OEF/OIF veterans with a reported history of combat-related trauma, probable PTSD diagnosis (score above 44 on the PTSD Checklist), scores above 28 on the Anxiety Sensitivity Index (ASI), and who have been medically cleared will be invited to participate (study personnel will assist the participant in getting clearance from their primary care physician or TRP staff).

Exclusion Criteria:

• Veterans will be excluded if they are judged to have medical conditions that might limit cooperation or compromise the integrity of the self-report or psychophysiological data (e.g., uncontrolled blood pressure, severe asthma, dementia, psychotic disorder, acute mania, current substance abuse, or taking medications that would reduce physiological responding). Veterans who are currently receiving (or who are scheduled to begin) individual exposure-based treatment for PTSD will be excluded from the study. As this project is designed as a pilot study, no exclusions will be made based on previous treatment or previous treatment refusal; however, treatment history data will be collected.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• Interoceptive Exposure
Exposure to internal stimuli.

Locations

Country	Name	City	State
United States	G.V. (Sonny) Montgomery VAMC	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
G.V. (Sonny) Montgomery VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Sensitivity Index-3		2 months	No