Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

NCT ID: NCT02085343

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-05-31

Brief Summary

This study tests whether a single session of exposure therapy may be enhanced by the addition of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100 acrophobic participants will be randomly assigned to receive standard exposure therapy (EXP), exposure therapy with safety behavior fading (EXP + SBF), exposure with safety behavior fading and anti-phobic actions (EXP + SBF + AA), or to a wait-list control group (WL).

Detailed Description

This study tests whether a single session of exposure therapy may be enhanced by the addition of one of two augmentation strategies, including engagement in anti-phobic actions and fading of safety behaviors. Because utilization of safety behaviors is functionally precluded by anti-phobic action, the present study design will both replicate and extend prior research by addressing whether anti-phobic actions enhance exposure therapy beyond the mere fading of safety behaviors. A total of 100 individuals between the ages of 18 and 65 meeting DSM-IV criteria for acrophobia (fear of heights) will be randomly assigned to one of four conditions including (1) standard exposure therapy, (2) exposure therapy with safety behavior fading, (3) exposure therapy with safety behavior fading and anti-phobic actions, and (4) a wait-list control condition. All participants will complete an online prescreen and face-to-face screening assessment to determine eligibility and pre-treatment symptom severity. Participants will also complete assessments at post-treatment and 1-month follow-up assessments. Subjective fear during two behavioral approach tests (in the treatment and generalization context, respectively) conducted at pre-treatment, post-treatment, and 1-month follow-up assessments will serve as the primary measure of treatment outcome. Additionally, a battery of self-report questionnaires will be completed at pre-treatment, during treatment, at post-treatment, and at a 1-month follow-up assessment.

Conditions

Specific Phobia

Keywords

Exposure therapy; Specific phobia; Fear of heights; Acrophobia; Safety behavior fading; Anti-phobic Actions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXP + SBF + AA

Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)

Group Type: EXPERIMENTAL

EXP

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement throughout supporting efforts at exposure. An instructional set will be provided prior to treatment presenting the rationale for exposure as an effective means of reducing pathological fear.

EXP + SBF

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided prior to treatment explaining how safety behaviors serve to maintain fear, and how their elimination may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment.

EXP + SBF + AA

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided explaining the rationale for eliminating safety behaviors, and how engagement in anti-phobic actions may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment, and will instruct participants to enact a series of progressively challenging anti-phobic actions which oppose the prototypical fear response.

EXP + SBF

Exposure therapy (EXP) with safety behavior fading (SBF)

Group Type: ACTIVE_COMPARATOR

EXP

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement throughout supporting efforts at exposure. An instructional set will be provided prior to treatment presenting the rationale for exposure as an effective means of reducing pathological fear.

EXP + SBF

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided prior to treatment explaining how safety behaviors serve to maintain fear, and how their elimination may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment.

EXP

Standard therapist-guided in vivo exposure therapy (EXP)

Group Type: ACTIVE_COMPARATOR

EXP

Intervention Type: BEHAVIORAL

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement throughout supporting efforts at exposure. An instructional set will be provided prior to treatment presenting the rationale for exposure as an effective means of reducing pathological fear.

Wait-list control

Subjects assigned to this arm will undergo assessments at Weeks 0, Week 1, and Week 5, but will not receive any interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EXP

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement throughout supporting efforts at exposure. An instructional set will be provided prior to treatment presenting the rationale for exposure as an effective means of reducing pathological fear.

Intervention Type: BEHAVIORAL

EXP + SBF

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided prior to treatment explaining how safety behaviors serve to maintain fear, and how their elimination may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment.

Intervention Type: BEHAVIORAL

EXP + SBF + AA

Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided explaining the rationale for eliminating safety behaviors, and how engagement in anti-phobic actions may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment, and will instruct participants to enact a series of progressively challenging anti-phobic actions which oppose the prototypical fear response.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard Therapist-Guided In Vivo Exposure Therapy (EXP); Exposure Therapy with Safety Behavior Fading (EXP + SBF); Exposure with Safety Behavior Fading and Anti-Phobic Actions

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 65.

2. Fluent in English (written and spoken). This is required because assessment instruments are validated only in English.

3. Meet DSM-IV criteria for specific phobia, natural environment type, with acrophobic concerns, based on the Composite International Diagnostic Interview (CIDI-Auto; World Health Organization, 1997).

4. Report moderate fear or avoidance (i.e., a score of 30 or higher) on a modified version of the Acrophobia Questionnaire (AQ; Cohen, 1977).

5. Exhibit at least moderate fear (i.e., a fear score of 50 or higher, where 0 = no fear and 100 = extreme fear) during two behavioral approach tests (BATs) consisting of ascending two moderately challenging flights of stairs.

Exclusion Criteria

1. Medical condition(s) which may prevent safely climbing or descending stairs or walking for more than 15 minutes at a time (It will be necessary to walk to different sites for the behavioral approach tests).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Telch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam R. Cobb, MA

Role: STUDY_DIRECTOR

The University of Texas at Austin

Michael J. Telch, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam R. Cobb, MA

Role: CONTACT

Phone: 325-201-4228

Email: adamrcobb@utexas.edu

Michael J. Telch, PhD

Role: CONTACT

Phone: 512-471-3722

Email: telch@austin.utexas.edu

Facility Contacts

Michael J. Telch, PhD

Role: primary

Other Identifiers

2013-02-0023

Identifier Type: -

Identifier Source: org_study_id