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

Обзор

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).

Подробное описание

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 .

Вмешательства

• Поведенческое 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
• Поведенческое Pre-Intervention Questionnaires (~10 minutes)
  Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.
• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Eating Attitudes Test - 26-item [Срок оценки: Baseline though study completion and up to one month follow-up]
• The Brief (Seven-item) Eating Disorder Examination Questionnaire [Срок оценки: Baseline though study completion and up to one month follow-up]
• Self-report Habit Index [Срок оценки: Baseline though study completion and up to one month follow-up]
• State Hope Scale - Agency Subscale [Срок оценки: Baseline though study completion and up to one month follow-up]
• Beck Hopelessness Scale - 4-item Version [Срок оценки: Baseline though study completion and up to one month follow-up]
• Barriers to Seeking Treatment. [Срок оценки: Baseline though study completion and up to one month follow-up]
• SSI [Срок оценки: Baseline though study completion and up to one month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06861608 · HM20030734 · FP00023118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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