Specific PhobiaNCT02905279
Spider Phobia Opposite Action Treatment Study
A study testing Biofeedback Relaxation Training, Exposure Therapy and Exposure with Threat-Relevant Opposite Actions in people with Specific Phobia, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Biofeedback Relaxation Training, Exposure Therapy and Exposure with Threat-Relevant Opposite Actions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 12 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently receiving psychotherapy for spider phobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions
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.
Read the detailed description
This study tests whether exposure therapy for fear of spiders can be enhanced with the use of opposite actions, which are actions opposite to fear-related action tendencies. The investigators will test two sub-types of opposite actions (a) threat-relevant opposite actions, which are actions antagonistic to specific threats associated with spider phobia, and (b) threat-irrelevant opposite actions, which are actions antagonistic to the fear response, but unrelated to specific threats associated with spider phobia. This exposure therapy enhanced with opposite actions will be compared with two control groups: standard exposure therapy and non-specific anxiety treatment (biofeedback relaxation training).
Individuals between the ages of 18-65 with elevated fear of spiders are randomly assigned to one of four treatment conditions (1) biofeedback relaxation training, (2) standard exposure therapy, (3) exposure therapy with threat-relevant opposite actions, and (4) exposure therapy with threat-irrelevant opposite actions. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately two weeks after treatment (follow-up). The pre-treatment assessment occurs on the same day as treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 14-21 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.
- Conditions
- Specific Phobia
- Being tested
- Biofeedback Relaxation Training, Exposure Therapy, Exposure with Threat-Relevant Opposite Actions, Exposure with Threat-Irrelevant Opposite Actions
- Keywords
- spider phobia, animal phobia, exposure therapy, biofeedback, relaxation training
- Medical subject headings
- Phobia, Specific, Arachnophobia, Zoophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback Relaxation TrainingBehavioural
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.
Exposure TherapyBehavioural
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.
Exposure with Threat-Relevant Opposite ActionsBehavioural
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-Irrelevant Opposite ActionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Active comparator | Biofeedback Relaxation Training Receives: Behavioral: Biofeedback Relaxation Training |
| Standard Exposure | Active comparator | Exposure Therapy Receives: Behavioral: Exposure Therapy |
| Exposure with Threat-Relevant OAs. | Experimental | Exposure with Threat-Relevant Opposite Actions Receives: Behavioral: Exposure with Threat-Relevant Opposite Actions |
| Exposure with Threat-Irrelevant OAs | Experimental | Exposure with Threat-Irrelevant Opposite Actions Receives: Behavioral: Exposure with Threat-Irrelevant Opposite Actions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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 post-treatment.
Measured: 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 in peak subjective fear (0 - 100), behavioral approach (0 - 10), and physiological reactivity (heart rate and skin conductance) to a live spider used during treatment (treatment context) from pre-treatment to follow-up
Measured: 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 in peak subjective fear (0 - 100), behavioral approach (0 - 10), and physiological reactivity (heart rate and skin conductance) to a live spider used during treatment (treatment context) from pre-treatment to post-treatment.
Measured: 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 in psychometrically validated questionnaire assessing spider phobia severity from pre-treatment to follow-up.
Measured: 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 in psychometrically validated questionnaire assessing severity of disgust response related to spider phobia from pre-treatment to follow-up.
Measured: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)
Change in psychometrically validated questionnaire assessing cognitions related to spider phobia from pre-treatment to follow-up.
Measured: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Jun 2016
- Primary completion3 Dec 2017
- Study completion12 Dec 2017
Why it stopped: Doctoral student running the study left for internship and did not finish the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, PhD, Study director, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905279
- Sponsor's protocol ID
- 2015-07-0020
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2016
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions
- ClinicalTrials.gov ID
- NCT02905279
- Acronym / sponsor ID
- 2015-07-0020
- Conditions
- Specific Phobia
- Keywords
- spider phobia, animal phobia, exposure therapy, biofeedback, relaxation training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Doctoral student running the study left for internship and did not finish the study
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study tests whether exposure therapy for fear of spiders can be enhanced with the use of opposite actions, which are actions opposite to fear-related action tendencies. The investigators will test two sub-types of opposite actions (a) threat-relevant opposite actions, which are actions antagonistic to specific threats associated with spider phobia, and (b) threat-irrelevant opposite actions, which are actions antagonistic to the fear response, but unrelated to specific threats associated with spider phobia. This exposure therapy enhanced with opposite actions will be compared with two control groups: standard exposure therapy and non-specific anxiety treatment (biofeedback relaxation training).
Individuals between the ages of 18-65 with elevated fear of spiders are randomly assigned to one of four treatment conditions (1) biofeedback relaxation training, (2) standard exposure therapy, (3) exposure therapy with threat-relevant opposite actions, and (4) exposure therapy with threat-irrelevant opposite actions. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately two weeks after treatment (follow-up). The pre-treatment assessment occurs on the same day as treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 14-21 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Active comparator | Behavioral: Biofeedback Relaxation TrainingBiofeedback Relaxation Training |
| Standard Exposure | Active comparator | Behavioral: Exposure TherapyExposure Therapy |
| Exposure with Threat-Relevant OAs. | Experimental | Behavioral: Exposure with Threat-Relevant Opposite ActionsExposure with Threat-Relevant Opposite Actions |
| Exposure with Threat-Irrelevant OAs | Experimental | Behavioral: Exposure with Threat-Irrelevant Opposite ActionsExposure with Threat-Irrelevant Opposite Actions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At Prescreen:
- At Screening visit: inability to complete close approach toward spiders as determined by the treatment context and generalization context Behavioral Approach Tests
Key exclusion criteria (1 listed)
- Currently receiving psychotherapy for spider phobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback Relaxation TrainingParticipants 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. | Behavioural | Biofeedback |
| Exposure TherapyParticipants 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. | Behavioural | Standard Exposure |
| Exposure with Threat-Relevant Opposite ActionsParticipants 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. | Behavioural | Exposure with Threat-Relevant OAs. |
| Exposure with Threat-Irrelevant Opposite ActionsParticipants 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. | Behavioural | Exposure with Threat-Irrelevant OAs |
Primary outcome
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)
Time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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
6 secondary outcomes
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-treatment)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)
Time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Results and safety
The study was stopped early (reason given: Doctoral student running the study left for internship and did not finish the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Specific Phobia
Not yet recruiting
Facing Fears From Home: Development, Feasibility and Maximization of FobiApp
Specific Phobia
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Recruiting
Efficacy of Expectancy Focused Exposure Therapy for Anxiety Disorders
Anxiety Disorders, Panic Disorder
Active, not recruiting
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
Not yet recruiting
A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
Specific Phobia, Animal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Telch, PhD study director
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Relaxation Training, Exposure Therapy and Exposure with Threat-Relevant Opposite Actions in people with Specific Phobia, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Doctoral student running the study left for internship and did not finish the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up) (time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.