A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders

August 4, 2026 updated by: Virginia Commonwealth University
The purpose of this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).

Study Overview

Status

Status

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

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

The emergence of EDs is bimodal such that there is a period of risk in early adolescence and a period of risk in late adolescence/early adulthood. EDs can lead to significant mental and physical health consequences and have one of the highest mortality rates of any mental illness. Prevention and treatment programs for EDs are fraught with barriers to access, particularly related to seeking care in-person. SSIs have been identified as a pathway to address the gap in care for EDs after showing promise for other psychiatric problems, including depression, anxiety, and suicidality .

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 (Estimated)

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.
160

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
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Courtney Breiner

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • EAT-26 score ≥ 20 ( EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise.)
  • English-language fluency, self-reported3
  • Access to a phone, tablet, or computer

Exclusion Criteria:

  • Failure to correctly complete one of the attention checks in the survey prior to the intervention
  • Failure to correctly complete both anagram tasks in the survey prior to the intervention
  • Completion of the screening survey or pre-intervention surveys in an improbably fast time

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: Prevention
  • 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: Experimental: psychoeducation experience single-session intervention (SSI)
This online randomized controlled trial of a habit training intervention includes one 30-minute session for young adults endorsing high levels of eating pathology. The intervention will occur at one timepoint.
Behavioral: Screening Questionnaire
Individuals will complete an online screening survey through an online study advertisement to determine initial eligibility. The screening survey will ask participants to report their gender and age and complete the Eating Attitudes Test - 26-item (EAT-26). EAT-26 scores equal to or greater than 20 indicate risk for an eating disorder. EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise. If an interested individual is not eligible, they will be notified that they are not currently eligible for the study and provided with resources.
Behavioral: Pre-Intervention Questionnaires (~10 minutes)
Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.
Behavioral: SSI (Single-session intervention (~30 minutes) Active arm
The SSI will consist of four components: 1)psychoeducation, 2) real-life examples, 3) common questions and misconceptions, and 4) providing advice to other young adults. Psychoeducation will focus on the brain bases of habit formation and EDs, as per REACH+ treatment manual. Participants will then be asked to think of a real-life example of an eating habit in which they have been engaged, such as limiting their intake of dessert foods. Participants will then be provided with REACH+ developed psychoeducation regarding changing habits, including information on competing responses, stimulus control, and exposure. Participants will have the opportunity to write out how they could use one of these strategies to tackle the habit that they previously wrote about. They will be provided with a worksheet to help them move through each aspect of changing their habit based on what they learned.
Behavioral: End-of-Intervention Questionnaires (~5 minutes)
Participants will complete additional questionnaires at the end of the intervention, including acceptability ratings and program feedback. Participants will provide an email address at the end of the questionnaires for receipt of four-week follow-up questionnaires.
Placebo Comparator: Control: will be matched to the SSI by including both reading and writing exercises.
The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.
Behavioral: Screening Questionnaire
Individuals will complete an online screening survey through an online study advertisement to determine initial eligibility. The screening survey will ask participants to report their gender and age and complete the Eating Attitudes Test - 26-item (EAT-26). EAT-26 scores equal to or greater than 20 indicate risk for an eating disorder. EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise. If an interested individual is not eligible, they will be notified that they are not currently eligible for the study and provided with resources.
Behavioral: Pre-Intervention Questionnaires (~10 minutes)
Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.
Behavioral: End-of-Intervention Questionnaires (~5 minutes)
Participants will complete additional questionnaires at the end of the intervention, including acceptability ratings and program feedback. Participants will provide an email address at the end of the questionnaires for receipt of four-week follow-up questionnaires.
Behavioral: SSI (Single-session intervention (~30 minutes) control arm
The control condition will be matched to the SSI by including both reading and writing exercises. The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.

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
Eating Attitudes Test - 26-item
Time Frame: Baseline though study completion and up to one month follow-up
This 26-item measure will be used to assess eating disorder, including bingeing, purging, and exercise behaviors. According to this methodology, individuals who score 20 or more on the test should be interviewed by a qualified professional to determine if they meet the diagnostic criteria for an eating disorder. If you have a low score on the EAT-26 (below 20), you still could have a serious eating problem, so do not let the results deter you from seeking help. For example, some individuals with Binge Eating Disorder (BED) score low on the EAT-26 but may have a serious eating disorder.
Baseline though study completion and up to one month follow-up
The Brief (Seven-item) Eating Disorder Examination Questionnaire
Time Frame: Baseline though study completion and up to one month follow-up
This measure will be used to assess eating behaviors over the past month. The seven-item version consists of seven items derived from the original Eating Disorder Examination Questionnaire and assesses for dietary restraint, shape/weight overvaluation, and body dissatisfaction. It consists of three subscales: dietary restraint (items 1, 3 and 4), shape/weight overvaluation (items 22 and 23) and body dissatisfaction (items 25 and 26).
Baseline though study completion and up to one month follow-up
Self-report Habit Index
Time Frame: Baseline though study completion and up to one month follow-up
The self-report habit index measures habit strength, which is the underlying mechanism being targeted in the current intervention. 7-point Likert scale from "strongly disagree" to "strongly agree." Higher scores indicate a stronger habit, suggesting the behavior is more automatic and less consciously controlled.
Baseline though study completion and up to one month follow-up
State Hope Scale - Agency Subscale
Time Frame: Baseline though study completion and up to one month follow-up
The 3-item agency subscale of the State Hope Scale measures belief in one's capacity to initiate and sustain actions. Research has shown that high agency is predictive of goal-related activities and utilization of coping skills. Higher scores on the agency subscale generally indicate a stronger sense of personal agency and belief in one's ability to take control and actively pursue goals.
Baseline though study completion and up to one month follow-up
Beck Hopelessness Scale - 4-item Version
Time Frame: Baseline though study completion and up to one month follow-up
This 4-item measure assesses hopelessness about the future with excellent psychometric properties and good internal consistency. typically calculated by summing up the responses to the four selected items, with a potential range from 0 to 4, where higher scores indicate greater levels of hopelessness.
Baseline though study completion and up to one month follow-up
Barriers to Seeking Treatment.
Time Frame: Baseline though study completion and up to one month follow-up
Help-seeking barriers will be assessed using this 26-item measure that was created in alignment with results of a systematic review of barriers and facilitators to help-seeking in eating disorders. A high score on a barrier-to-treatment scale suggests that the individual perceives that particular factor as a significant obstacle to seeking professional help.
Baseline though study completion and up to one month follow-up
SSI
Time Frame: Baseline though study completion and up to one month follow-up
The SSI will consist of four components: 1)psychoeducation, 2) real-life examples, 3) common questions and misconceptions, and 4) providing advice to other young adults based on what participants learned throughout the intervention. Psychoeducation will focus on the brain bases of habit formation and EDs, as per REACH+ treatment manual. Participants will then be asked to think of a real-life example of an eating habit in which they have been engaged, such as limiting their intake of dessert foods. Participants will then be provided with REACH+ developed psychoeducation regarding changing habits, including information on competing responses, stimulus control, and exposure. Participants will have the opportunity to write out how they could use one of these strategies to tackle the habit that they previously wrote about. They will be provided with a worksheet to help them move through through each aspect of changing their habit based on what they learned.
Baseline though study completion and up to one month follow-up

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.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eating Disorders Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Courtney Breiner, Virginia Commonwealth 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 15, 2025

Primary Completion (Estimated)

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.
December 31, 2026

Study Completion (Estimated)

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.
December 31, 2026

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).
January 27, 2025

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.
February 28, 2025

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.
March 6, 2025

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.
August 5, 2026

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.
August 4, 2026

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.
August 1, 2026

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.
  • HM20030734
  • FP00023118 (Other Grant/Funding Number: National Eating Disorder Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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