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

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: Recruiting
• Conditions: Eating Disorder Not Otherwise Specified
• Intervention / Treatment: Behavioral: Screening Questionnaire; Behavioral: Pre-Intervention Questionnaires (~10 minutes); Behavioral: SSI (Single-session intervention (~30 minutes) Active arm; Behavioral: End-of-Intervention Questionnaires (~5 minutes); Behavioral: SSI (Single-session intervention (~30 minutes) control arm

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: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney Breiner; Phone Number: 518-376-2543; Email: breinerc@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Courtney Breiner; Phone Number: 518-376-2543; Email: breinerc@vcu.edu
      • Principal Investigator: Courtney Breiner

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Eating Attitudes Test - 26-item	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	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	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	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	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.	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	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

• Sponsor: Virginia Commonwealth University
• Collaborators: National Eating Disorders Association
• Investigators: Principal Investigator: Courtney Breiner, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: prevention of eating disorders
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID 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