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Идёт набор NCT06012045

Enhanced Cue Exposure Therapy for Negative Emotional Eating

Без фазы С лечением Disordered Eating Behaviors Binge Eating

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enhanced Cue Exposure Therapy, Behavioral Lifestyle Intervention.
Кому может быть актуально
Состояния в реестре: Disordered Eating Behaviors, Binge Eating. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Официальное название

A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating

Обзор

The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.

Подробное описание

Participants will be randomly assigned to either the experimental treatment or control BLI group. Participants in the experimental group will receive 6 weeks of E-CET treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. Outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups.

Research question 1:

Is E-CET an efficacious intervention for reducing NEE?

Hypothesis 1:

E-CET will lead to greater reductions in NEE at posttreatment and follow-up compared to BLI.

Research question 2:

Does E-CET work via the violation of the CS-US expectancies?

Hypothesis 2:

Changes in the believability of CS-US expectancies will mediate the treatment effects of E-CET on NEE.

Вмешательства

  • Поведенческое Enhanced Cue Exposure Therapy
    The E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. Session #1 will be used to introduce to the participant the rationale and procedures of E-CET to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. Sessions #2 to #5 will be in vivo exposures. The interventionist will prompt the participant to evaluate the CS-US expectancy t
  • Поведенческое Behavioral Lifestyle Intervention
    The BLI will consist of six weekly sessions of behavioral counselling integrating behavioral strategies for participants to make dietary changes. These behavioral strategies will include education about healthy and balanced diets, goal-setting, problem-solving, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.

Первичные конечные точки

  • Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) [Срок оценки: 14 months (up to 12-month follow-up)]
  • Number of EMA-measured NEE episodes [Срок оценки: 14 months (up to 12-month follow-up)]
Вторичные конечные точки (7)
  • Changes in NEE [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in caloric consumption [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS) [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in body weight [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) [Срок оценки: 14 months (up to 12-month follow-up)]
  • Changes in quality of life measured using the Satisfaction with Life Scale (SWLS) [Срок оценки: 14 months (up to 12-month follow-up)]

Критерии участия

Критерии включения

  • aged 18 or over
  • a score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire lasting for three months or longer
  • confirmed to have, on average, two or more NEE episodes per week using ecological momentary assessments (EMAs)

Критерии исключения

  • active suicidal intent or plan
  • psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with NEE
  • currently receiving psychotherapy, or adjusting to changing psychiatric medication
  • substance abuse
  • any conditions or circumstances that prevent the participant from receiving all treatment sessions

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
Лечение

Центры проведения

Гонконг · 1 центр
  • The University of Hong Kong — Гонконг

Публикации

  • Chan WS, Cheng WY. Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating. Contemp Clin Trials. 2025 Jul;154:107955. doi: 10.1016/j.cct.2025.107955. Epub 2025 May 18. PMID 40393615

Идентификаторы

NCT: NCT06012045 · EA220560

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗