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Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

Primary Purpose

Specific Phobia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EXP
EXP + SBF
EXP + SBF + AA
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring Exposure therapy, Specific phobia, Fear of heights, Acrophobia, Safety behavior fading, Anti-phobic Actions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

EXP + SBF + AA

EXP + SBF

EXP

Wait-list control

Arm Description

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

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

Standard therapist-guided in vivo exposure therapy (EXP)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acrophobia Questionnaire - Modified (Cohen, 1977; Wolitzky & Telch, 2009)
20-item Likert-type scale assessing acrophobic symptoms
Height estimation task
Perceptual task requiring estimation of height from the top of a flight of stairs
Heart rate
Heart rate reactivity assessed using a Polar Heart Rate Monitor.
Treatment Process Questionnaire
Self-efficacy, anticipated anxiety, anticipated danger, and utilization of safety behaviors assessed via self-report.

Full Information

First Posted
January 22, 2014
Last Updated
November 12, 2017
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02085343
Brief Title
Anti-phobic and Safety Behaviors in the Treatment of Acrophobia
Official Title
Anti-phobic and Safety Behaviors in the Treatment of Acrophobia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
Exposure therapy, Specific phobia, Fear of heights, Acrophobia, Safety behavior fading, Anti-phobic Actions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXP + SBF + AA
Arm Type
Experimental
Arm Description
Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)
Arm Title
EXP + SBF
Arm Type
Active Comparator
Arm Description
Exposure therapy (EXP) with safety behavior fading (SBF)
Arm Title
EXP
Arm Type
Active Comparator
Arm Description
Standard therapist-guided in vivo exposure therapy (EXP)
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Subjects assigned to this arm will undergo assessments at Weeks 0, Week 1, and Week 5, but will not receive any interventions.
Intervention Type
Behavioral
Intervention Name(s)
EXP
Other Intervention Name(s)
Standard Therapist-Guided In Vivo Exposure Therapy (EXP)
Intervention Description
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
Intervention Name(s)
EXP + SBF
Other Intervention Name(s)
Exposure Therapy with Safety Behavior Fading (EXP + SBF)
Intervention Description
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
Intervention Name(s)
EXP + SBF + AA
Other Intervention Name(s)
Exposure with Safety Behavior Fading and Anti-Phobic Actions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak subjective fear (0 - 100) upon exposure to heights in the generalization context.
Description
Peak subjective fear ratings (0 - 100).
Time Frame
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 Outcome Measure Information:
Title
Acrophobia Questionnaire - Modified (Cohen, 1977; Wolitzky & Telch, 2009)
Description
20-item Likert-type scale assessing acrophobic symptoms
Time Frame
Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).
Title
Height estimation task
Description
Perceptual task requiring estimation of height from the top of a flight of stairs
Time Frame
Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).
Title
Heart rate
Description
Heart rate reactivity assessed using a Polar Heart Rate Monitor.
Time Frame
Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).
Title
Treatment Process Questionnaire
Description
Self-efficacy, anticipated anxiety, anticipated danger, and utilization of safety behaviors assessed via self-report.
Time Frame
Treatment (1 week following pre-treatment assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam R. Cobb, MA
Phone
325-201-4228
Email
adamrcobb@utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J. Telch, PhD
Phone
512-471-3722
Email
telch@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam R. Cobb, MA
Organizational Affiliation
The University of Texas at Austin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael J. Telch, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J. Telch, PhD
Phone
512-404-9188
Email
telch@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

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