Text Message Safety Behavior Fading for Appearance Concerns

• Sponsor: Florida State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05612425
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 17.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Body Dysmorphic Disorders; Social Anxiety Disorder; Eating Disorders	Behavioral: Safety Behavior Fading for Appearance Concerns; Behavioral: Unhealthy Behavior Fading	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are randomized to one of two conditionsParticipants are randomized to one of two conditions
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial
• Anticipated Study Start Date: Jan 17, 2023
• Anticipated Primary Completion Date: Oct 28, 2023
• Anticipated Study Completion Date: Dec 28, 2023

Arms and Interventions

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 decreased and/or eliminated each safety behavior over the previous day.	Behavioral: Safety Behavior Fading for Appearance Concerns; Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Active Comparator: Unhealthy Behavior Fading 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 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.	Behavioral: Unhealthy Behavior Fading; Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.

Outcome Measures

Primary Outcome Measures

1. Change in Social Appearance Anxiety Scale [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.

2. Change in Eating Disorder-15 [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.

3. Change in Social Phobia Inventory [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.

4. Credibility and Expectancy Questionnaire [Day 0]

   Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.

5. Change in Appearance Behaviors Checklist [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.

6. Change in Unhealthy Behaviors Checklist [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.

Secondary Outcome Measures

1. Center for Epidemiologic Studies Depression Scale [Day 0, Day 28, Day 56]

   Self-report measure of depression symptom severity.

2. Assessment of ideal self [Day 0, Day 28, Day 56]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• elevated appearance concerns as defined by a score of 53 or higher on the SAAS

• Being female

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida State University, Department of Psychology	Tallahassee	Florida	United States	32306

Sponsors and Collaborators

• Florida State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jesse Cougle, Principal Investigator, Florida State University
• ClinicalTrials.gov Identifier: NCT05612425
• Other Study ID Numbers: STUDY00003637
• First Posted: Nov 10, 2022
• Last Update Posted: Jan 5, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jesse Cougle, Principal Investigator, Florida State University: safety behaviors; intervention; text message; appearance concerns
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Feeding and Eating Disorders; Phobia, Social; Body Dysmorphic Disorders

Study Results

No Results Posted as of Jan 5, 2023