NCT02905279

Brief Summary

This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the use of antagonistic or opposite actions during treatment. The goal of the study is to compare the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in extinguishing fear.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

August 23, 2016

Last Update Submit

December 4, 2020

Conditions

Keywords

spider phobiaanimal phobiaexposure therapybiofeedbackrelaxation training

Outcome Measures

Primary Outcomes (1)

  • Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)

    Change in peak subjective fear (0 - 100 scale), behavioral approach (0 - 13 scale), and physiological reactivity (heart rate and skin conductance) to a live spider not used during treatment (generalization context) from pre-treatment to follow-up

    Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

Secondary Outcomes (6)

  • Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-treatment)

    Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)

  • Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)

    Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

  • Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to Post-treatment)

    Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)

  • Change in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)

    Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

  • Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)

    Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

  • +1 more secondary outcomes

Study Arms (4)

Biofeedback

ACTIVE COMPARATOR

Biofeedback Relaxation Training

Behavioral: Biofeedback Relaxation Training

Standard Exposure

ACTIVE COMPARATOR

Exposure Therapy

Behavioral: Exposure Therapy

Exposure with Threat-Relevant OAs.

EXPERIMENTAL

Exposure with Threat-Relevant Opposite Actions

Behavioral: Exposure with Threat-Relevant Opposite Actions

Exposure with Threat-Irrelevant OAs

EXPERIMENTAL

Exposure with Threat-Irrelevant Opposite Actions

Behavioral: Exposure with Threat-Irrelevant Opposite Actions

Interventions

Participants will receive one-session biofeedback relaxation training (24 minutes) for anxiety reduction. Prior to biofeedback, participants will receive education about spiders and the development and maintenance of spider phobia.

Biofeedback

Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. Prior to exposure therapy, participants will receive education about spiders and the development and the development and maintenance of spider phobia.

Standard Exposure

Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. During exposure, participants will engage in actions opposite to the tendencies associated with threat avoidance. Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.

Exposure with Threat-Relevant OAs.

Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. During exposure therapy, participants will engage in actions opposite of the action tendencies associated with the fear, but unrelated to the specific threats associated with spider phobia. Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.

Exposure with Threat-Irrelevant OAs

Eligibility Criteria

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

You may qualify if:

  • At Prescreen:
  • Total score of greater than or equal to 70 on the Fear of Spiders - Questionnaire (with higher scores indicating higher fear levels).
  • Indicates ongoing fear of spiders and inability to complete close approach towards spiders on brief questionnaire.
  • At Screening visit: inability to complete close approach toward spiders as determined by the treatment context and generalization context Behavioral Approach Tests

You may not qualify if:

  • Currently receiving psychotherapy for spider phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Phobia, SpecificArachnophobiaZoophobia

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael J Telch, PhD

    The University of Texas at Austin

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 19, 2016

Study Start

June 1, 2016

Primary Completion

December 3, 2017

Study Completion

December 12, 2017

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations