Body Dysmorphic DisordersNCT05612425
Text Message Safety Behavior Fading for Appearance Concerns
A study testing Safety Behavior Fading for Appearance Concerns and Unhealthy Behavior Fading in people with Body Dysmorphic Disorders 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 fadinig intervention compared to an unhealthy behavior fading intervention for appearance concerns. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Body Dysmorphic Disorders, Social Anxiety Disorder, Eating Disorders
- What is being tested?
- Safety Behavior Fading for Appearance Concerns and Unhealthy Behavior Fading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 15 Apr 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elevated appearance concerns as defined by a score of 53 or higher on the SAAS
- Being female
Who cannot join
- being male
- Score of 52 or lower on the SAAS
- 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, Department of Psychology
Tallahassee, Florida, 32306
About this study
Official title: Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial
The current study aims to explore the efficacy of a text message based safety behavior fadinig intervention compared to an unhealthy behavior fading 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.
Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors. They will also 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.
- Being tested
- Safety Behavior Fading for Appearance Concerns, Unhealthy Behavior Fading
- Keywords
- safety behaviors, intervention, text message, appearance concerns
- 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.
Unhealthy Behavior FadingBehavioural
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders 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 decreased and/or eliminated each safety behavior over the previous day. Receives: Behavioral: Safety Behavior Fading for Appearance Concerns |
| Unhealthy Behavior Fading | Active comparator | Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors that are unrelated to appearance. They will also receive daily reminders via text message to decrease these behaviors, along with a behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each behavior over the previous day. Receives: Behavioral: Unhealthy Behavior Fading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Appearance Anxiety Scale
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
Change in Eating Disorder-15
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
Change in Social Phobia Inventory
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
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Measured: Day 0
Change in Appearance Behaviors Checklist
Self-report scale used to measure frequency of engaging in appearance related safety behaviors. This scale will be used as a manipulation check.
Measured: Day 0, Day 28, Day 56
Change in Unhealthy Behaviors Checklist
Self-report scale used to measure frequency of engaging in unhealthy behaviors. This scale will be used as a manipulation check.
Measured: Day 0, Day 28, Day 56
Beliefs About Appearance Scale
Self-report scale for measuring appearance importance for use in clinical outcome studies. Each item is rated on a 0-4 scale with a total score range of 0-80 with higher scores indicating greater appearance importance.
Measured: Day 0, Day 28, Day 56
UCLA Loneliness Scale-8
Self-report scale for measuring loneliness for use in clinical outcome studies. Total scores range from 0 to 32 with higher scores indicating higher loneliness.
Measured: Day 0, Day 28, Day 56
Secondary outcomes (2)
Center for Epidemiologic Studies Depression Scale
Self-report measure of depression symptom severity.
Measured: Day 0, Day 28, Day 56
Assessment of ideal self
Self-report measure of appearance importance where individuals must allocate a budget of 100 to 7 different ideals including appearance, creativity, friendliness, work ethic, intelligence, humor, and income.
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 posted10 Nov 2022
- Study start12 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
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 DisordersStudies 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
- 203 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612425
- Sponsor's protocol ID
- STUDY00003637
- Status last verified
- May 2024
- First submitted
- 4 Nov 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel TA, Cougle JR. Safety behavior reduction for appearance concerns: A randomized controlled trial of a smartphone-based intervention. J Consult Clin Psychol. 2024 Dec;92(12):788-799. doi: 10.1037/ccp0000920. Epub 2024 Oct 24.
PubMed 39446647
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05612425
- Acronym / sponsor ID
- STUDY00003637
- Keywords
- safety behaviors, intervention, text message, appearance concerns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 10 Nov 2022 (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 fadinig intervention compared to an unhealthy behavior fading 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.
Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors. They will also 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.
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 decreased and/or eliminated each safety behavior over the previous day. |
| Unhealthy Behavior Fading | Active comparator | Behavioral: Unhealthy Behavior FadingIndividuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors that are unrelated to appearance. They will also receive daily reminders via text message to decrease these behaviors, along with a behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each behavior over the previous day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elevated appearance concerns as defined by a score of 53 or higher on the SAAS
- Being female
Key exclusion criteria (4 listed)
- being male
- Score of 52 or lower on the SAAS
- 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 |
| Unhealthy Behavior FadingParticipants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress. | Behavioural | Unhealthy Behavior Fading |
Primary outcome
Change in Social Appearance Anxiety Scale
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.
Change in Eating Disorder-15
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.
Change in Social Phobia Inventory
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
Time frame: Day 0
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Change in Appearance Behaviors Checklist
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.
Change in Unhealthy Behaviors Checklist
Time frame: Day 0, Day 28, Day 56
Self-report scale used to measure frequency of engaging in unhealthy behaviors. This scale will be used as a manipulation check.
Beliefs About Appearance Scale
Time frame: Day 0, Day 28, Day 56
Self-report scale for measuring appearance importance for use in clinical outcome studies. Each item is rated on a 0-4 scale with a total score range of 0-80 with higher scores indicating greater appearance importance.
UCLA Loneliness Scale-8
Time frame: Day 0, Day 28, Day 56
Self-report scale for measuring loneliness for use in clinical outcome studies. Total scores range from 0 to 32 with higher scores indicating higher loneliness.
2 secondary outcomes
Center for Epidemiologic Studies Depression Scale
Time frame: Day 0, Day 28, Day 56
Assessment of ideal self
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 7 May 2024.
- Derived from this study: PubMed 39446647Patel TA, Cougle JR. Safety behavior reduction for appearance concerns: A randomized controlled trial of a smartphone-based intervention. J Consult Clin Psychol. 2024 Dec;92(12):788-799. doi: 10.1037/ccp0000920. Epub 2024 Oct 24.
- 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.
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 Unhealthy Behavior Fading in people with Body Dysmorphic Disorders 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 2 inclusion and 4 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 7 May 2024. 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?
Change in Social Appearance Anxiety Scale (time frame: Day 0, Day 28, Day 56). The study lists 8 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 NCT05612425, 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 7 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.