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Text Message Safety Behavior Fading for Appearance Concerns

Primary Purpose

Body Dysmorphic Disorders, Social Anxiety Disorder, Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Behavior Fading for Appearance Concerns
Unhealthy Behavior Fading
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorders focused on measuring safety behaviors, intervention, text message, appearance concerns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Safety Behavior Fading

Unhealthy Behavior Fading

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Credibility and Expectancy Questionnaire
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
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.
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.
Beliefs About Appearance Scale
Self-report scale for measuring appearance importance for use in clinical outcome studies.
UCLA Loneliness Scale-8
Self-report scale for measuring loneliness for use in clinical outcome studies.

Secondary Outcome Measures

Center for Epidemiologic Studies Depression Scale
Self-report measure of depression symptom severity.
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.

Full Information

First Posted
November 4, 2022
Last Updated
September 29, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05612425
Brief Title
Text Message Safety Behavior Fading for Appearance Concerns
Official Title
Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 21, 2023 (Anticipated)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders, Social Anxiety Disorder, Eating Disorders
Keywords
safety behaviors, intervention, text message, appearance concerns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two conditions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Behavior Fading
Arm Type
Experimental
Arm Description
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.
Arm Title
Unhealthy Behavior Fading
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Safety Behavior Fading for Appearance Concerns
Intervention Description
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Intervention Type
Behavioral
Intervention Name(s)
Unhealthy Behavior Fading
Intervention Description
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.
Primary Outcome Measure Information:
Title
Change in Social Appearance Anxiety Scale
Description
Self-report scale that measures appearance anxiety symptoms. Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns.
Time Frame
Day 0, Day 28, Day 56
Title
Change in Eating Disorder-15
Description
Self-report scale that measures eating disorder symptoms. Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology.
Time Frame
Day 0, Day 28, Day 56
Title
Change in Social Phobia Inventory
Description
Self-report scale that measures social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety.
Time Frame
Day 0, Day 28, Day 56
Title
Credibility and Expectancy Questionnaire
Description
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Time Frame
Day 0
Title
Change in Appearance Behaviors Checklist
Description
Self-report scale used to measure frequency of engaging in appearance related safety behaviors. This scale will be used as a manipulation check.
Time Frame
Day 0, Day 28, Day 56
Title
Change in Unhealthy Behaviors Checklist
Description
Self-report scale used to measure frequency of engaging in unhealthy behaviors. This scale will be used as a manipulation check.
Time Frame
Day 0, Day 28, Day 56
Title
Beliefs About Appearance Scale
Description
Self-report scale for measuring appearance importance for use in clinical outcome studies.
Time Frame
Day 0, Day 28, Day 56
Title
UCLA Loneliness Scale-8
Description
Self-report scale for measuring loneliness for use in clinical outcome studies.
Time Frame
Day 0, Day 28, Day 56
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale
Description
Self-report measure of depression symptom severity.
Time Frame
Day 0, Day 28, Day 56
Title
Assessment of ideal self
Description
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.
Time Frame
Day 0, Day 28, Day 56

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tapan Patel, M.S.
Phone
863-517-2584
Email
patel@psy.fsu.edu
Facility Information:
Facility Name
Florida State University, Department of Psychology
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Text Message Safety Behavior Fading for Appearance Concerns

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