A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Number of EMA-measured NEE episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Number of EMA-measured NEE episodes
时间窗: 14 months (up to 12-month follow-up)
Participants will respond to fixed-interval prompts asking whether they have engaged in NEE in the assessment period. The sum of all the reported episodes during the seven days will be computed to indicate the frequency of NEE per week.
Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
时间窗: 14 months (up to 12-month follow-up)
The subscale consists of 13 items assessing the tendency to eat in response to negative emotions, on a 5-point Likert scale from 1 (never) to 5 (very often). The cutoff point of \>3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity.
次要结局
- Changes in quality of life measured using the Satisfaction with Life Scale (SWLS)(14 months (up to 12-month follow-up))
- Changes in NEE(14 months (up to 12-month follow-up))
- Changes in caloric consumption(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)(14 months (up to 12-month follow-up))
- Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21)(14 months (up to 12-month follow-up))
- Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)(14 months (up to 12-month follow-up))
- Changes in body weight(14 months (up to 12-month follow-up))
研究者
Dr. Chan Wai Sze
Principal Investigator, Assistant Professor
The University of Hong Kong