NCT02085343

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5.1 years

First QC Date

January 22, 2014

Last Update Submit

November 12, 2017

Conditions

Keywords

Exposure therapySpecific phobiaFear of heightsAcrophobiaSafety behavior fadingAnti-phobic Actions

Outcome Measures

Primary Outcomes (1)

  • Peak subjective fear (0 - 100) upon exposure to heights in the generalization context.

    Peak subjective fear ratings (0 - 100).

    Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).

Secondary Outcomes (4)

  • Acrophobia Questionnaire - Modified (Cohen, 1977; Wolitzky & Telch, 2009)

    Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).

  • Height estimation task

    Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).

  • Heart rate

    Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).

  • Treatment Process Questionnaire

    Treatment (1 week following pre-treatment assessment)

Study Arms (4)

EXP + SBF + AA

EXPERIMENTAL

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

Behavioral: EXPBehavioral: EXP + SBFBehavioral: EXP + SBF + AA

EXP + SBF

ACTIVE COMPARATOR

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

Behavioral: EXPBehavioral: EXP + SBF

EXP

ACTIVE COMPARATOR

Standard therapist-guided in vivo exposure therapy (EXP)

Behavioral: EXP

Wait-list control

NO INTERVENTION

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

Interventions

EXPBEHAVIORAL

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.

Also known as: Standard Therapist-Guided In Vivo Exposure Therapy (EXP)
EXPEXP + SBFEXP + SBF + AA
EXP + SBFBEHAVIORAL

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.

Also known as: Exposure Therapy with Safety Behavior Fading (EXP + SBF)
EXP + SBFEXP + SBF + AA
EXP + SBF + AABEHAVIORAL

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.

Also known as: Exposure with Safety Behavior Fading and Anti-Phobic Actions
EXP + SBF + AA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65.
  • Fluent in English (written and spoken). This is required because assessment instruments are validated only in English.
  • 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).
  • Report moderate fear or avoidance (i.e., a score of 30 or higher) on a modified version of the Acrophobia Questionnaire (AQ; Cohen, 1977).
  • 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.

You may not qualify if:

  • \. 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Phobia, SpecificAcrophobia

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Adam R. Cobb, MA

    The University of Texas at Austin

    STUDY DIRECTOR
  • Michael J. Telch, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam R. Cobb, MA

CONTACT

Michael J. Telch, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

March 12, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

De-identified data can be shared upon request to the corresponding investigator / author upon project completion. Contact Michael J. Telch, Ph.D at telch@austin.utexas.edu

Locations