- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589621
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
May 29, 2026 updated by: Jesse Cougle, Florida State University
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions
The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a progressive muscle relaxation intervention for appearance concerns.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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 progressive muscle relaxation condition will be instructed to try and practice it daily for the 28 days.
They will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
Study Type
Interventional
Enrollment (Estimated)
300
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 Contact
- Name: Tapan Patel, Master of Science
- Phone Number: 863-517-2584
- Email: patel@psy.fsu.edu
Study Locations
-
-
Florida
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Tallahassee, Florida, United States, 32308
- Recruiting
- Florida State University
-
Contact:
- Tapan Patel, Master of Science
- Phone Number: 8635172584
- Email: patel@psy.fsu.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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- being between the ages of 18 and 65 years old
- having an internet-capable smart-phone
- scoring at or above the empirical cutoff for appearance concerns measured by the Social Appearance Anxiety Scale (i.e., 52)
Exclusion Criteria:
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
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: Single
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.
Other Names:
|
|
Active Comparator: Progressive Muscle Relaxation
Participants in this condition will be instructed to try and practice progressive muscle relaxation daily for 28 days.
To match safety behavior fading they will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
|
Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
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
|
|
The Social Appearance Anxiety Scale (SAAS)
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
|
|
Appearance Anxiety Inventory (AAI; Veale et al., 2014)
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale that measures of body dysmorphic symptoms.
Scores range from 0 to 40 with higher scores indicating higher levels of body dysmorphic symptoms.
|
Day 0, Day 28, Day 56
|
|
Eating Disorder-15 (ED-15; Tatham et al., 2015).
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
|
|
The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale for measuring body dissatisfaction for use in clinical outcome studies.
Each item is rated on a 0-5 scale with a total score range of 9-54 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction.
|
Day 0, Day 28, Day 56
|
|
Credibility and Expectancy Questionnaire (CEQ; 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Time Frame: Day 0, Day 28, Day 56
|
Self-report measure of anxiety symptom severity.
Each item is rated on a 0 to 3 scale.
Total scores range from 0 to 28 with higher scores indicating greater anxiety severity.
|
Day 0, Day 28, Day 56
|
|
Appearance Preference Task
Time Frame: Day 0, Day 28, Day 56
|
Computerized forced-choice task measuring appearance importance relative to other favorable characteristics.
The APT randomly presents a series of 33 word pairs and asks the participant to select the concept that is more important to them.
Each pair consists of a positive appearance-related adjective and a positive character trait unrelated to appearance (e.g., beautiful-responsible).
Higher scores indicate greater endorsement of appearance words.
|
Day 0, Day 28, Day 56
|
|
Social Interaction Scale (Author Constructed)
Time Frame: Day 0, Day 28, Day 56
|
Single-item self-report scale that the extent to which individuals engage with their social support networks.
This question asks: "what percentage of your time awake did you spend interacting with others this past week (0% =No time at all, 100% =all of the time)?"
|
Day 0, Day 28, Day 56
|
|
Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)
Time Frame: Day 0, Day 28, Day 56
|
Self-report scale that measures cognitions related to body dysmorphic disorder.
Scores range from 0 to 190 with higher scores indicating higher levels of maladaptive cognitions related to body dysmorphic disorder.
|
Day 0, Day 28, Day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 29, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
May 11, 2026
First Submitted That Met QC Criteria
May 11, 2026
First Posted (Actual)
May 15, 2026
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Phobic Disorders
- Anxiety Disorders
- Somatoform Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Phobia, Social
- Feeding and Eating Disorders
- Body Dysmorphic Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Psychotherapy
- Behavioral Disciplines and Activities
- Hypnosis
- Autogenic Training
Other Study ID Numbers
- STUDY00007433
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
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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