Body Dysmorphic DisorderNCT07589621
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
A study testing Safety Behavior Fading for Appearance Concerns and Progressive Muscle Relaxation in people with Body Dysmorphic Disorder and Eating Disorders, 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 progressive muscle relaxation intervention for appearance concerns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Dysmorphic Disorder, Eating Disorders, Social Anxiety Disorder
- What is being tested?
- Safety Behavior Fading for Appearance Concerns and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32308
About this study
Official title: 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.
Read the 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.
- Being tested
- Safety Behavior Fading for Appearance Concerns, Progressive Muscle Relaxation
- Medical subject headings
- Body Dysmorphic Disorders, Feeding and Eating Disorders, Phobia, Social
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
Also called ARSB Fading
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Progressive Muscle RelaxationBehavioural
Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress.
| 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 |
| Progressive Muscle Relaxation | Active comparator | 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. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Social Appearance Anxiety Scale (SAAS)
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
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
Appearance Anxiety Inventory (AAI; Veale et al., 2014)
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.
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
Eating Disorder-15 (ED-15; Tatham et al., 2015).
Self-report scale that measures eating disorder symptoms. Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology.
Measured: Day 0, Day 28, Day 56
The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).
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.
Measured: Day 0, Day 28, Day 56
Credibility and Expectancy Questionnaire (CEQ; 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
Secondary outcomes (5)
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
Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
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.
Measured: Day 0, Day 28, Day 56
Appearance Preference Task
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.
Measured: Day 0, Day 28, Day 56
Social Interaction Scale (Author Constructed)
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)?"
Measured: Day 0, Day 28, Day 56
Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)
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.
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 posted15 May 2026
- Study start29 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589621
- Sponsor's protocol ID
- STUDY00007433
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions
- ClinicalTrials.gov ID
- NCT07589621
- Acronym / sponsor ID
- STUDY00007433
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 May 2026 (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 progressive muscle relaxation intervention for appearance concerns.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| 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. |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
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 ConcernsAlso: ARSB FadingParticipants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress. | Behavioural | Safety Behavior Fading |
| Progressive Muscle RelaxationParticipants are asked to practice relaxation daily via text message reminder and checklists to monitor progress. | Behavioural | Progressive Muscle Relaxation |
Primary outcome
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.
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
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.
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.
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.
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.
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.
5 secondary outcomes
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Time frame: Day 0, Day 28, Day 56
Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Time frame: Day 0, Day 28, Day 56
Appearance Preference Task
Time frame: Day 0, Day 28, Day 56
Social Interaction Scale (Author Constructed)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Body Dysmorphic Disorder
Not yet recruitingObservational study
Social Media Use and Motherhood
Postpartum Period
Not yet recruiting
Overvaluation of Weight and Shape Intervention vs The Body Project
Body Image, Mental Health Outcomes
RecruitingPhase 2
Study of Dextromethorphan in OCD and Related Disorders
Obsessive-Compulsive Disorder, Illness Anxiety Disorder
Recruiting
Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder
Body Dysmorphic Disorders
Active, not recruitingObservational study
A Multi-Dimensional Model of cAre and transItion for Patients With cOmplex RAre Diseases
Rare Diseases, Mitochondrial Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Progressive Muscle Relaxation in people with Body Dysmorphic Disorder and Eating Disorders, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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) (time frame: Day 0, Day 28, Day 56). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.