NCT07589621

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress9%
May 2026Dec 2026

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 11, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • The Social Appearance Anxiety Scale (SAAS)

    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

  • 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

  • Appearance Anxiety Inventory (AAI; Veale et al., 2014)

    Self-report scale that measures of body dysmorphic symptoms. Scores range from 0 to 40 with higher scores indicating higher levels of body dysmorphic symptoms.

    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

  • Eating Disorder-15 (ED-15; Tatham et al., 2015).

    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

  • The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).

    Self-report scale for measuring body dissatisfaction for use in clinical outcome studies. Each item is rated on a 0-5 scale with a total score range of 9-54 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction.

    Day 0, Day 28, Day 56

  • Credibility and Expectancy Questionnaire (CEQ; 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

Secondary Outcomes (5)

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

    Day 0, Day 28, Day 56

  • Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)

    Day 0, Day 28, Day 56

  • Appearance Preference Task

    Day 0, Day 28, Day 56

  • Social Interaction Scale (Author Constructed)

    Day 0, Day 28, Day 56

  • Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)

    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

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Participants in this condition will be instructed to try and practice progressive muscle relaxation daily for 28 days. To match safety behavior fading they will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.

Behavioral: Progressive Muscle Relaxation

Interventions

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

Also known as: ARSB Fading
Safety Behavior Fading

Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress.

Progressive Muscle Relaxation

Eligibility Criteria

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

You may qualify if:

  • being between the ages of 18 and 65 years old
  • having an internet-capable smart-phone
  • scoring at or above the empirical cutoff for appearance concerns measured by the Social Appearance Anxiety Scale (i.e., 52)

You may not qualify if:

  • changes in psychotropic medication in the last 4 weeks
  • failing attention checks in baseline data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32308, United States

RECRUITING

MeSH Terms

Conditions

Body Dysmorphic DisordersFeeding and Eating DisordersPhobia, Social

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Tapan Patel, Master of Science

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations