- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896435
Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns (Open ARSB Study) (Open ARSB RCT)
September 12, 2025 updated by: Jesse Cougle, Florida State University
Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns
The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a relaxing video intervention for appearance concerns.
Study Overview
Status
Completed
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.
The daily reminder will include the following language: "Hi!
This is a friendly reminder to avoid using your checklist behaviors.
Please tap the link below to access today's checklist: [link to checklist]."
Text messages will be delivered using EZtexting a text messaging platform used for research and marketing.
Note that no identifying information will be included in this platform.
Each participants phone number will be accompanied with a anonymized ID code.
Individuals randomly assigned to the relaxing video condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to close their eyes and focus their attention on the present moment while listening to relaxing piano music and songbirds.
Study Type
Interventional
Enrollment (Actual)
401
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
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Seeking treatment for appearance concerns
Exclusion Criteria:
- 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
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: 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 engaged in 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: Relaxing Video
Individuals randomly assigned to the relaxing video condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to close their eyes and focus their attention on the present moment while listening to relaxing piano music and songbirds.
|
Participants are asked to view weekly videos lasting 15 minutes each to engage in relaxation exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Social Appearance Anxiety Scale (SAAS; Hart et al., 2008)
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
|
|
Social Phobia Inventory (SPIN; Connor et al., 2000)
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
|
|
Eating Disorder Inventory (EDI; Garner et al., 1983).
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring drive for thinness, bulimia, and body dissatisfaction for use in clinical outcome studies.
Each item is rated on a 0-5 scale with a total score range of 0-125 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction.
|
Day 0, Day 28, Day 56
|
|
Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000).
Time Frame: Day 0
|
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Three items are rated on a 0-10 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility.
|
Day 0
|
|
Appearance Behaviors Checklist past-week version (author constructed)
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.
Each item is rated on a 0 to 10 scale.
Total scores range from 0 to 130 with higher scores indicating greater engagement in appearance-related safety behaviors
|
Day 0, Day 28, Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distress Intolerance Index (McHugh & Otto, 2012)
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring tolerance to distress for use in clinical outcome studies.
Each item is rated on a 0-4 scale with a total score range of 0-40 with higher scores indicating greater intolerance of distress.
|
Day 0, Day 28, Day 56
|
|
Frost Multidimensional Perfectionism Scale-Concerns over mistakes subscale (Frost et al., 1990)
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring concerns for making mistakes for use in clinical outcome studies.
Each item is rated on a 0-4 scale with a total score range of 0-36 with higher scores indicating greater concerns for making mistakes.
|
Day 0, Day 28, Day 56
|
|
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Time Frame: Day 0, Day 28, Day 56
|
Self-report measure of depression symptom severity.
Each item is rated on a 0 to 3 scale.
Total scores range from 0 to 30 with higher scores indicating greater depression severity.
|
Day 0, Day 28, Day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jesse Cougle, Doctor of Philosophy, Florida State University
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 (Actual)
April 15, 2025
Primary Completion (Actual)
September 8, 2025
Study Completion (Actual)
September 8, 2025
Study Registration Dates
First Submitted
March 20, 2025
First Submitted That Met QC Criteria
March 20, 2025
First Posted (Actual)
March 26, 2025
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 12, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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