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Recruiting NCT07589621

Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns

No phase Interventional Body Dysmorphic Disorder Eating Disorders Social Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safety Behavior Fading for Appearance Concerns, Progressive Muscle Relaxation.
Who it may be relevant to
Registry conditions: Body Dysmorphic Disorder, Eating Disorders, Social Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions

Overview

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.

Detailed 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. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today's checklist: \[link to checklist\]." Text messages will be delivered using EZtexting a text messaging platform used for research and marketing. Note that no identifying information will be included in this platform. Each participants phone number will be accompanied with a anonymized ID code. Individuals randomly assigned to the progressive muscle relaxation condition will be instructed to try and practice it daily for the 28 days. 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.

Interventions

  • 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.
  • Behavioral Progressive Muscle Relaxation
    Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress.

Primary outcome measures

  • The Social Appearance Anxiety Scale (SAAS) [Time frame: Day 0, Day 28, Day 56]
  • Appearance Behaviors Checklist past-week version (author constructed) [Time frame: Day 0, Day 28, Day 56]
  • Appearance Anxiety Inventory (AAI; Veale et al., 2014) [Time frame: Day 0, Day 28, Day 56]
  • Social Phobia Inventory (SPIN; Connor et al., 2000) [Time frame: Day 0, Day 28, Day 56]
  • Eating Disorder-15 (ED-15; Tatham et al., 2015). [Time frame: Day 0, Day 28, Day 56]
  • The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983). [Time frame: Day 0, Day 28, Day 56]
  • Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000). [Time frame: Day 0]
Secondary outcome measures (5)
  • Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994) [Time frame: Day 0, Day 28, Day 56]
  • Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) [Time frame: Day 0, Day 28, Day 56]
  • Appearance Preference Task [Time frame: Day 0, Day 28, Day 56]
  • Social Interaction Scale (Author Constructed) [Time frame: Day 0, Day 28, Day 56]
  • Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016) [Time frame: Day 0, Day 28, Day 56]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Florida State University — Tallahassee

Identifiers

NCT: NCT07589621 · STUDY00007433

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗