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

ConditionEating Disorder Not Otherwise Specified
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-22
SponsorVirginia Commonwealth University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Screening Questionnaire

    Behavioral

    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.

  • Pre-Intervention Questionnaires (~10 minutes)

    Behavioral

    Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.

  • SSI (Single-session intervention (~30 minutes) Active arm

    Behavioral

    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.

  • SSI (Single-session intervention (~30 minutes) control arm

    Behavioral

    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.

  • End-of-Intervention Questionnaires (~5 minutes)

    Behavioral

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Experimental: psychoeducation experience single-session intervention (SSI)Experimental treatment 4 interventions
Group B: Control: will be matched to the SSI by including both reading and writing exercises.Placebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline though study completion and up to one month follow-up
2

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).

Time frame
Baseline though study completion and up to one month follow-up
3

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.

Time frame
Baseline though study completion and up to one month follow-up
4

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.

Time frame
Baseline though study completion and up to one month follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

National Eating Disorders Association

Collaborator

Source ClinicalTrials.gov
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