ClinicalTrials.gg
CompletedNCT06896435Updated Sep 15, 2025

Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns (Open ARSB Study)

An interventional study of Safety Behavior Fading for Appearance Concerns and Relaxing Video in Body Dysmorphic Disorder, Social Anxiety Disorder and Eating Disorders, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
401
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Body Dysmorphic Disorder
  • Social Anxiety Disorder
  • Eating Disorders

Keywords

  • appearance concerns
  • safety behavior
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 401 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Florida State University is the lead sponsor of 249 studies on the registry; 47 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Seeking treatment for appearance concerns

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
401 participants (actual)

Study arms

  • 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.

    Behavioral: Safety Behavior Fading for Appearance Concerns

  • 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.

    Behavioral: Relaxing Video

Interventions

  • BehavioralSafety Behavior Fading for Appearance Concerns

    Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.

  • BehavioralRelaxing Video

    Participants are asked to view weekly videos lasting 15 minutes each to engage in relaxation exercises.

06

What researchers measure

Primary outcomes

  1. The Social Appearance Anxiety Scale (SAAS; Hart et al., 2008)

    Self-report scale that measures appearance anxiety symptoms. Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns.

    Time frame: Day 0, Day 28, Day 56

  2. Social Phobia Inventory (SPIN; Connor et al., 2000)

    Self-report scale that measures social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety.

    Time frame: Day 0, Day 28, Day 56

  3. Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000).

    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.

    Time frame: Day 0

  4. Eating Disorder Inventory (EDI; Garner et al., 1983).

    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.

    Time frame: Day 0, Day 28, Day 56

  5. Appearance Behaviors Checklist past-week version (author constructed)

    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

    Time frame: Day 0, Day 28, Day 56

Secondary outcomes

  1. Distress Intolerance Index (McHugh & Otto, 2012)

    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.

    Time frame: Day 0, Day 28, Day 56

  2. Frost Multidimensional Perfectionism Scale-Concerns over mistakes subscale (Frost et al., 1990)

    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.

    Time frame: Day 0, Day 28, Day 56

  3. Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)

    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.

    Time frame: Day 0, Day 28, Day 56

07

Study locations

1 site
  • Florida State University
    Tallahassee, Florida 32304, United States
08

References and documents

Publications

  • Patel TA, Cougle JR. Who benefits from a digital intervention for appearance concerns? A randomized controlled trial of a large mixed-gender sample. J Consult Clin Psychol. 2026 Apr;94(4):216-227. doi: 10.1037/ccp0001007. PubMed 42080861 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06896435
Responsible party
Jesse Cougle (Principal Investigator, Florida State University) — Principal investigator
First posted
Mar 26, 2025
Start date
Apr 15, 2025
Primary completion
Sep 8, 2025
Completion
Sep 8, 2025
Last update
Sep 15, 2025

Study contacts

Jesse Cougle, Doctor of Philosophy
study director · Florida State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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