## Protocol Section
### Identification Module
**NCT ID:** NCT00795379

**Brief Title:** Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy

**Official Title:** Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy

#### Organization Study ID Info
**ID:** MIRECC 5-1006
#### Organization
**Class:** FED
**Full Name:** G.V. (Sonny) Montgomery VA Medical Center
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2008-11-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-11-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2009-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-11

**Status Verified Date:** 2008-11

#### Study First Post Date
**Date:** 2008-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-19
**Study First Submit QC Date:** 2008-11-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** G.V. (Sonny) Montgomery VA Medical Center

#### Responsible Party

**Old Name Title:** Kevin S. Del Ben, Ph.D. Assistant Professor

**Old Organization:** G.V. (Sonny) Montgomery VA Medical Center

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anxiety

**Keywords:**

- Psychotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Interoceptive Exposure

**Label:** IE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** waitlist control

**Label:** 2

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IE

**Description:** Exposure to internal stimuli.

**Name:** Interoceptive Exposure

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Anxiety Sensitivity Index-3

**Time Frame:** 2 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kdelben@psychiatry.umsmed.edu

**Name:** Kevin S Del Ben, Ph.D.

**Phone:** 601-984-5807

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jackson

**Contacts:**

***Contact 1:***

- **Email:** kdelben@psychiatry.umsmed.edu

- **Name:** Kevin S Del Ben, Ph.D.

- **Phone:** 601-984-5807

- **Role:** CONTACT

**Country:** United States

**Facility:** G.V. (Sonny) Montgomery VAMC

**State:** Mississippi

**Status:** RECRUITING

**Zip:** 39216

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
