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

Not Applicable

Recruiting

• Conditions: Eating Disorder Not Otherwise Specified

• Registration Number: NCT06861608
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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).

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 Timeline

• Study Start: 2025-01-15
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating Attitudes Test - 26-item	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.
The Brief (Seven-item) Eating Disorder Examination Questionnaire	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).
Self-report Habit Index	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.
State Hope Scale - Agency Subscale	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.
Beck Hopelessness Scale - 4-item Version	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.
Barriers to Seeking Treatment.	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.
SSI	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States