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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05612425
Other study ID # STUDY00003637
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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