- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02085343
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- 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 Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Recruiting
- The University of Texas at Austin
-
Contact:
- Michael J. Telch, PhD
- Phone Number: 512-404-9188
- Email: telch@austin.utexas.edu
-
-
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
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: EXP + SBF + AA
Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (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 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:
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:
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:
|
|
ACTIVE_COMPARATOR: EXP + SBF
Exposure therapy (EXP) with safety behavior fading (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 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:
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:
|
|
ACTIVE_COMPARATOR: EXP
Standard therapist-guided in vivo exposure therapy (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:
|
|
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
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
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
Investigators
- 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
February 1, 2013
Primary Completion (ANTICIPATED)
March 1, 2018
Study Completion (ANTICIPATED)
May 1, 2018
Study Registration Dates
First Submitted
January 22, 2014
First Submitted That Met QC Criteria
March 10, 2014
First Posted (ESTIMATE)
March 12, 2014
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 12, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Specific Phobia
-
Johns Hopkins UniversityCompletedSpecific Phobia | Specific Phobia, Animal | Specific Phobia, Situational | Specific Phobia, Natural Environment | Childhood Anxiety DisorderUnited States
-
University of South FloridaNational Institute of Mental Health (NIMH)Not yet recruitingSpecific Phobia, AnimalUnited States
-
Columbia UniversityWithdrawn
-
Ruhr University of BochumCompletedFear of Heights | Specific Phobia, SituationalGermany
-
University of Nevada, RenoCompletedSpecific Phobia | Arachnophobia | Spider PhobiaUnited States
-
University of CyprusYouth Board of CyprusCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalWithdrawnSpecific Phobia
-
University of GroningenZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Universitat Jaume IRecruitingSpecific Phobia, AnimalSpain
-
University of OtagooVRcomeCompleted
Clinical Trials on EXP
-
University of North Carolina, Chapel HillCompleted
-
University of North Carolina, Chapel HillAmerican Psychological Association (APA); Association for Behavioral and Cognitive...Completed
-
Superior UniversityActive, not recruiting
-
Superior UniversityActive, not recruiting
-
Lithuanian University of Health SciencesCompleted
-
Superior UniversityActive, not recruiting
-
Milton S. Hershey Medical CenterRecruitingAnorexia Nervosa | Binge-Eating Disorder | Bulimia Nervosa | Eating DisordersUnited States
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Karolinska InstitutetRecruiting
-
VA Office of Research and DevelopmentActive, not recruitingLower-Limb AmputationUnited States