Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

November 12, 2017 updated by: Michael J. Telch, University of Texas at Austin
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • The University of Texas at Austin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: EXP + SBF + AA
Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)
Behavioral: 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.
Other Names:
  • Standard Therapist-Guided In Vivo Exposure Therapy (EXP)
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.
Other Names:
  • Exposure Therapy with Safety Behavior Fading (EXP + SBF)
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.
Other Names:
  • Exposure with Safety Behavior Fading and Anti-Phobic Actions
ACTIVE_COMPARATOR: EXP + SBF
Exposure therapy (EXP) with safety behavior fading (SBF)
Behavioral: 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.
Other Names:
  • Standard Therapist-Guided In Vivo Exposure Therapy (EXP)
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.
Other Names:
  • Exposure Therapy with Safety Behavior Fading (EXP + SBF)
ACTIVE_COMPARATOR: EXP
Standard therapist-guided in vivo exposure therapy (EXP)
Behavioral: 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.
Other Names:
  • Standard Therapist-Guided In Vivo Exposure Therapy (EXP)
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak subjective fear (0 - 100) upon exposure to heights in the generalization context.
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acrophobia Questionnaire - Modified (Cohen, 1977; Wolitzky & Telch, 2009)
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).
20-item Likert-type scale assessing acrophobic symptoms
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
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).
Perceptual task requiring estimation of height from the top of a flight of stairs
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
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).
Heart rate reactivity assessed using a Polar Heart Rate Monitor.
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
Time Frame: Treatment (1 week following pre-treatment assessment)
Self-efficacy, anticipated anxiety, anticipated danger, and utilization of safety behaviors assessed via self-report.
Treatment (1 week following pre-treatment assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adam R. Cobb, MA, The University of Texas at Austin
  • Principal Investigator: Michael J. Telch, PhD, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-02-0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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