A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
研究概览
简要总结
This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Specifically, the study will assess whether MT+ active tDCS, as opposed to MT+ sham tDCS or waiting list control, reduces high calorie food craving and consumption. Findings will inform the development of a future large-scale randomised controlled trial. The trial will be conducted in the UK.
详细描述
A randomised controlled feasibility trial with three parallel arms: [MT + real tDCS] vs [MT + sham tDCS] vs [Waiting list control group].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 w
- •Overweight or obese (BMI ≥25 kg/ m2) according to World Health Organisation (WHO) criteria.
- •Use and understand English as a language for everyday conversation.
- •Have access to a laptop or desktop computer with webcam and to able to attend baseline, post intervention and follow up assessments in the Institute of Psychiatry, Psychology and Neuroscience (KCL).
排除标准
- •Insufficient written and spoken English
- •All known contraindications to tDCS (Brunoni et al., 2012)
- •Pregnancy; history of neurological disease and/or seizure
- •Having any metallic implants in the head or body
- •History of head or eye injury
- •Significant health problems in the previous six months
- •A lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder; any other primary psychiatric disorder requiring treatment in its own right
- •Taking psychotropic medication
- •Taking medication for weight loss Regular, current or past, mindfulness meditation or yoga practice (defined as > 20 minutes, twice or more per week during the past 2 months)
- •Consuming more than 14 units of alcohol per week who are unwilling to reduce their alcohol intake for the duration of the treatment
- •Current illicit drug use
- •Learning difficulties that would preclude safe tDCS self-administration and/or completion of questionnaire measures and neurocognitive tasks (e.g.; working memory and inhibitory control)
- •Current atypical anorexia nervosa or purging once a week or more.
结局指标
主要结局
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
时间窗: post treatment assessment (assessed at week 3 post start of treatment)
By assessing the tDCS session completed and the number of the MT sessions completed will be tracked through the app across the full 8 weeks
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate
时间窗: post treatment assessment (assessed at week 3 post start of treatment)
Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame.
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates
时间窗: post treatment assessment (assessed at week 3 post start of treatment) and at follow up (assessed at week 8 post start of treatment)
determine retention rates from randomization through intervention completion
Participant views about treatment acceptability
时间窗: post treatment assessment (assessed at week 3 post start of treatment)
Treatment Acceptability Questionnaire: asking participants to indicate if MT with self-administered tDCS is an acceptable approach to treatment and whether they would recommend MT + tDCS to a friend if they were struggling with their weight.
次要结局
- Change mindful eating-related outcomes(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in food cravings using the Power of Food Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in Body composition(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mood using Positive and Negative Affect Schedule(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using Barrett Impulsiveness Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using Delayed Gratification Inventory(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mindfulness outcomes(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Eating Disorder Symptoms(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in high calorie food intake in the lab(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in food cravings(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in weight loss using the bioelectrical impedance machine(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in emotion regulation using Emotion Regulation Questionnaire(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mood using the The Depression, Anxiety and Stress-Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in working memory(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using the Go no Go Task(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in high calorie food intake in the lab(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in food cravings(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in weight loss using the bioelectrical impedance machine(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in emotion regulation using Emotion Regulation Questionnaire(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mood using the The Depression, Anxiety and Stress-Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in working memory(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using the Go no Go Task(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change mindful eating-related outcomes(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in food cravings using the Power of Food Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in Body composition(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mood using Positive and Negative Affect Schedule(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using Barrett Impulsiveness Scale(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in inhibitory control using Delayed Gratification Inventory(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Change in mindfulness outcomes(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))
- Eating Disorder Symptoms(Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment))