Body Dysmorphic DisorderNCT06896435
Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns (Open ARSB Study)
A study testing Safety Behavior Fading for Appearance Concerns and Relaxing Video in people with Body Dysmorphic Disorder and Social Anxiety Disorder, run by Florida State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Dysmorphic Disorder, Social Anxiety Disorder, Eating Disorders
- What is being tested?
- Safety Behavior Fading for Appearance Concerns and Relaxing Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 8 Sep 2025
- 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
- Seeking treatment for appearance concerns
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: 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.
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.
- Being tested
- Safety Behavior Fading for Appearance Concerns, Relaxing Video
- Keywords
- appearance concerns, safety behavior
- Medical subject headings
- Body Dysmorphic Disorders, Phobia, Social, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Behavior Fading for Appearance ConcernsBehavioural
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Relaxing VideoBehavioural
Participants are asked to view weekly videos lasting 15 minutes each to engage in relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Safety Behavior Fading | Experimental | 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. Receives: Behavioral: Safety Behavior Fading for Appearance Concerns |
| Relaxing Video | Active comparator | 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. Receives: Behavioral: Relaxing Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, Day 28, Day 56
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.
Measured: Day 0, Day 28, Day 56
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.
Measured: Day 0
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.
Measured: Day 0, Day 28, Day 56
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
Measured: Day 0, Day 28, Day 56
Secondary outcomes (3)
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.
Measured: Day 0, Day 28, Day 56
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.
Measured: Day 0, Day 28, Day 56
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.
Measured: Day 0, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Apr 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies 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
- Model description
- Participants are randomized to one of two conditions
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
- Investigators
- Jesse Cougle, Doctor of Philosophy, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896435
- Sponsor's protocol ID
- STUDY00005977
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns
- ClinicalTrials.gov ID
- NCT06896435
- Acronym / sponsor ID
- STUDY00005977
- Keywords
- appearance concerns, safety behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two conditions
| Arm | Type | Receives |
|---|---|---|
| Safety Behavior Fading | Experimental | Behavioral: Safety Behavior Fading for Appearance ConcernsIndividuals 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. |
| Relaxing Video | Active comparator | Behavioral: Relaxing VideoIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Seeking treatment for appearance concerns
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Safety Behavior Fading for Appearance ConcernsParticipants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress. | Behavioural | Safety Behavior Fading |
| Relaxing VideoParticipants are asked to view weekly videos lasting 15 minutes each to engage in relaxation exercises. | Behavioural | Relaxing Video |
Primary outcome
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.
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.
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.
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.
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
3 secondary outcomes
Distress Intolerance Index (McHugh & Otto, 2012)
Time frame: 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
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Time frame: Day 0, Day 28, Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 42080861Patel 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.
- Individual participant dataSharing planned: No
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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.
Jesse Cougle, Doctor of Philosophy study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Behavior Fading for Appearance Concerns and Relaxing Video in people with Body Dysmorphic Disorder and Social Anxiety Disorder, run by Florida State University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Social Appearance Anxiety Scale (SAAS; Hart et al., 2008) (time frame: Day 0, Day 28, Day 56). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06896435, which also lists 1 linked publication.
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 15 Sep 2025.