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

Overview

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 .

Interventions

• 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
• 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 psy
• 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.
• 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.

Primary outcome measures

• Eating Attitudes Test - 26-item [Time frame: 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]
• Self-report Habit Index [Time frame: 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]
• Beck Hopelessness Scale - 4-item Version [Time frame: 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]
• SSI [Time frame: Baseline though study completion and up to one month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06861608 · HM20030734 · FP00023118

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗