NCT05612425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

November 4, 2022

Last Update Submit

May 5, 2024

Conditions

Keywords

safety behaviorsinterventiontext messageappearance concerns

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • Credibility and Expectancy Questionnaire

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

    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.

    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.

    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.

    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.

    Day 0, Day 28, Day 56

Secondary Outcomes (2)

  • Center for Epidemiologic Studies Depression Scale

    Day 0, Day 28, Day 56

  • Assessment of ideal self

    Day 0, Day 28, Day 56

Study Arms (2)

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.

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.

Behavioral: Unhealthy Behavior Fading

Interventions

Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.

Safety Behavior Fading

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

Unhealthy Behavior Fading

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Body Dysmorphic DisordersPhobia, SocialFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersPhobic DisordersAnxiety DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of two conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 10, 2022

Study Start

January 12, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations