Targeting Top-down and Bottom-up Processing in Eating Disorders Using Computerized Training Approaches: A Multimodal Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in eating disorder symptomatology
研究概览
简要总结
This research project aims to explore the effectiveness of combined go/no-go training and implementation intentions in targeting binge eating frequency among people with binge eating disorder and bulimia nervosa.
The full intervention is 4 weeks long and consists of completing the training and food diaries every day and meeting with the researcher twice for EEG recording. Moreover, it involves completing questionnaires at baseline, at intervention completion, and one month after the intervention.
Moreover, healthy control participants will be recruitment to complete baseline questionnaires and take part in one EEG recording session in order to assess baseline differences in brain activation in response to computer tasks.
详细描述
Participants will learn about the study through flyers, e-mail, and social media (i.e. twitter and Facebook) which will describe the interventional nature of the study, the main eligibility criteria, and the researcher's contact information. Interested individuals will be asked to contact the researchers, who will then send an information sheet detailing the study procedure and what participation would involve. After reading the information sheet, interested individuals will be contacted by the researchers in order to confirm all eligibility criteria including diagnostic assessment. If these are met a PDF of the consent form will be sent to the participants, including information about their rights as participants and their ability to withdraw at any time without having to give a reason. Participants who sign the consent form will respond to the email with the attached document. Next, researchers will contact the participant to set an appointment to enter the lab for the first EEG recording. Before entering the lab, participants will be asked to complete a food diary and complete the complete a battery of questionnaires. The questionnaires include: 1) a demographic questionnaire, 2) eating disorders examination questionnaire, 3) food ratings test, 4) self-regulation of eating behaviour questionnaire for adults, 5) The negative urgency scale, 6) the adults eating behaviour questionnaire, 7) GAD-7, and 8) PHQ-9.
Upon participants' arrival to the lab, participants will be asked to complete the food rating task. Next, they will learn to complete the training tasks (i.e. food specific go/no-go and general go/no-go) and perform them during EEG recording. They will be offered the opportunity to ask questions relating to the task or the EEG at any time. Their weight will also be measured.
Participants will be asked to complete the training and complete food diaries every day for four weeks. The successful/ unsuccessful attempts at implementation intentions will be assessed weekly by a mentor. A researcher/clinician will discuss setting the implementation intention goals with the participant over email. At the end of the training, participants will enter the lab to re-complete the four tasks while researchers record brain activation using the EEG. They will also be asked to complete the food rating task again and their weight will be re-assessed. Before leaving, they will be asked to complete a feedback sheet in which they can express their experience with the training, in terms of facilitators and barriers and visual analogue scales that will ask participants to rate the acceptability, usefulness and level of burden experienced with training.
Participants will then be followed up at 1 month post-intervention; they will be asked to complete the battery of questionnaires used at baseline and post-intervention.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of an Eating Disorder (Bulimia Nervosa or Binge Eating Disorder); 2) No severe psychiatric comorbidity (e.g. psychosis); 3) Fluency in English; 4) No visual impairment; 5) No cognitive/neurological impairment; 6) No drugs or alcohol abuse; 7) No use of weight-loss medication; 8 No metabolic disorder; 9) Above 18 years old and below 60 years old.
排除标准
- •No diagnosis of an eating disorder; 2) Severe psychiatric comorbidity; 3) No English language fluency; 4) Visual impairment (not correctable with eye-wear); 5) Cognitive/neurological impairment; 6) Drug or alcohol abuse; 7) Use of weight-loss medication; 8) A metabolic disorder; 9) Below 18 years old and above 60 years old.
研究组 & 干预措施
Food specific inhibitory control training
The stimuli in this task will involve pictures of food.
干预措施: Food specific Inhibitory control training (Behavioral)
Food specific inhibitory control training
The stimuli in this task will involve pictures of food.
干预措施: Implementation intentions (Behavioral)
General inhibitory control training
The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.
干预措施: Implementation intentions (Behavioral)
General inhibitory control training
The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.
干预措施: General inhibitory control training (Behavioral)
Baseline brain activation assessment (healthy controls)
This arm is included to assess brain activation using EEG among healthy controls at baseline in order to compare responses to participants with eating disorders.
结局指标
主要结局
Change in eating disorder symptomatology
时间窗: This will be assessed at baseline, intervention completion, and follow-up (1 month later)
Decrease in binge eating frequency and decrease in compensatory behaviours.
次要结局
- Change in weight/BMI(This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks))
- Changes in Low Calorie Food Valuation(This will be assessed at baseline (Time 0) and post-intervention (4 weeks).)
- Change in inhibitory control(This will be assessed at baseline (Time 0) and intervention completion (4 weeks).)
- Change in anxiety and depression symptoms(This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks))
- Changes in High Calorie Food Valuation(This will be assessed at baseline (Time 0) and post-intervention (4 weeks).)