NCT06896435

Brief Summary

The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a relaxing video intervention for appearance concerns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

March 20, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

appearance concernssafety behavior

Outcome Measures

Primary Outcomes (5)

  • The Social Appearance Anxiety Scale (SAAS; Hart et al., 2008)

    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

  • Social Phobia Inventory (SPIN; Connor et al., 2000)

    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 (Devilly & Borkovec, 2000).

    Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Three items are rated on a 0-10 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility.

    Day 0

  • Eating Disorder Inventory (EDI; Garner et al., 1983).

    Self-report scale for measuring drive for thinness, bulimia, and body dissatisfaction for use in clinical outcome studies. Each item is rated on a 0-5 scale with a total score range of 0-125 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction.

    Day 0, Day 28, Day 56

  • Appearance Behaviors Checklist past-week version (author constructed)

    Self-report scale used to measure frequency of engaging in appearance-related safety behaviors. This scale will be used as a manipulation check. Each item is rated on a 0 to 10 scale. Total scores range from 0 to 130 with higher scores indicating greater engagement in appearance-related safety behaviors

    Day 0, Day 28, Day 56

Secondary Outcomes (3)

  • Distress Intolerance Index (McHugh & Otto, 2012)

    Day 0, Day 28, Day 56

  • Frost Multidimensional Perfectionism Scale-Concerns over mistakes subscale (Frost et al., 1990)

    Day 0, Day 28, Day 56

  • Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)

    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 engaged in each safety behavior over the previous day.

Behavioral: Safety Behavior Fading for Appearance Concerns

Relaxing Video

ACTIVE COMPARATOR

Individuals randomly assigned to the relaxing video condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to close their eyes and focus their attention on the present moment while listening to relaxing piano music and songbirds.

Behavioral: Relaxing Video

Interventions

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

Safety Behavior Fading
Relaxing VideoBEHAVIORAL

Participants are asked to view weekly videos lasting 15 minutes each to engage in relaxation exercises.

Relaxing Video

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking treatment for appearance concerns

You may not qualify if:

  • 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

Tallahassee, Florida, 32304, United States

Location

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 Officials

  • Jesse Cougle, Doctor of Philosophy

    Florida State University

    STUDY DIRECTOR

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

March 20, 2025

First Posted

March 26, 2025

Study Start

April 15, 2025

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations