- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05612425
Text Message Safety Behavior Fading for Appearance Concerns
Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Description: Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors.
Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.
Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors. They will also receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tapan Patel, M.S.
- Phone Number: 863-517-2584
- Email: patel@psy.fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Recruiting
- Florida State University, Department of Psychology
-
Contact:
- Jesse R Cougle, Ph.D.
- Phone Number: 850-645-8729
- Email: cougle@psy.fsu.edu
-
Principal Investigator:
- Jesse R Cougle, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- elevated appearance concerns as defined by a score of 53 or higher on the SAAS
- Being female
Exclusion Criteria:
- being male
- Score of 52 or lower on the SAAS
- Currently receiving treatment (therapy, counseling, etc.) for anxiety, depression, eating disorder, or body image/appearance concerns
- If applicable, unstable psychiatric medication usage any time over the past 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Safety Behavior Fading
Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors.
In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.
|
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
|
Active Comparator: Unhealthy Behavior Fading
Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors that are unrelated to appearance.
They will also receive daily reminders via text message to decrease these behaviors, along with a behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each behavior over the previous day.
|
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social Appearance Anxiety Scale
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale that measures appearance anxiety symptoms.
Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns.
|
Day 0, Day 28, Day 56
|
Change in Eating Disorder-15
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale that measures eating disorder symptoms.
Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology.
|
Day 0, Day 28, Day 56
|
Change in Social Phobia Inventory
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale that measures social anxiety symptoms.
Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety.
|
Day 0, Day 28, Day 56
|
Credibility and Expectancy Questionnaire
Time Frame: Day 0
|
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
|
Day 0
|
Change in Appearance Behaviors Checklist
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale used to measure frequency of engaging in appearance related safety behaviors.
This scale will be used as a manipulation check.
|
Day 0, Day 28, Day 56
|
Change in Unhealthy Behaviors Checklist
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale used to measure frequency of engaging in unhealthy behaviors.
This scale will be used as a manipulation check.
|
Day 0, Day 28, Day 56
|
Beliefs About Appearance Scale
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring appearance importance for use in clinical outcome studies.
Each item is rated on a 0-4 scale with a total score range of 0-80 with higher scores indicating greater appearance importance.
|
Day 0, Day 28, Day 56
|
UCLA Loneliness Scale-8
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring loneliness for use in clinical outcome studies.
Total scores range from 0 to 32 with higher scores indicating higher loneliness.
|
Day 0, Day 28, Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiologic Studies Depression Scale
Time Frame: Day 0, Day 28, Day 56
|
Self-report measure of depression symptom severity.
|
Day 0, Day 28, Day 56
|
Assessment of ideal self
Time Frame: Day 0, Day 28, Day 56
|
Self-report measure of appearance importance where individuals must allocate a budget of 100 to 7 different ideals including appearance, creativity, friendliness, work ethic, intelligence, humor, and income.
|
Day 0, Day 28, Day 56
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003637
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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