Text Message Safety Behavior Fading for Appearance Concerns

Eating Disorders Clinical Trial

Official title:

Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612425
• Other study ID #: STUDY00003637
• Status: Completed
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Body Dysmorphic Disorders
• Eating Disorders
• Feeding and Eating Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.
• Unhealthy Behavior Fading
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.

Locations

Country	Name	City	State
United States	Florida State University, Department of Psychology	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0, Day 28, Day 56
Primary	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.	Day 0, Day 28, Day 56
Primary	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.	Day 0, Day 28, Day 56
Primary	Credibility and Expectancy Questionnaire	Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.	Day 0
Primary	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.	Day 0, Day 28, Day 56
Primary	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.	Day 0, Day 28, Day 56
Primary	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.	Day 0, Day 28, Day 56
Primary	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.	Day 0, Day 28, Day 56
Secondary	Center for Epidemiologic Studies Depression Scale	Self-report measure of depression symptom severity.	Day 0, Day 28, Day 56
Secondary	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.	Day 0, Day 28, Day 56