Text Message Safety Behavior Fading for Appearance Concerns

May 5, 2024 updated by: Jesse Cougle, Florida State University

Safety Behavior Fading Versus Unhealthy Behavior Fading for Appearance Concerns: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University, Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Safety Behavior Fading
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
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Active Comparator: Unhealthy Behavior Fading
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
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Social Appearance Anxiety Scale
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Day 0
Change in Appearance Behaviors Checklist
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0, Day 28, Day 56
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
Time Frame: Day 0, Day 28, Day 56
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Center for Epidemiologic Studies Depression Scale
Time Frame: Day 0, Day 28, Day 56
Self-report measure of depression symptom severity.
Day 0, Day 28, Day 56
Assessment of ideal self
Time Frame: Day 0, Day 28, Day 56
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.
Day 0, Day 28, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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