Testing the Added Benefit of Acceptance and Commitment Therapy (ACT) in the Treatment of Obesity: a Pilot Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Obesity is an 'epidemic' within the UK. Individuals living with obseity are at risk of developing cancer, heart problems and dieing. Furthermore, obesity impacts on psychological wellbeing via lowered self-efficacy, self-esteem, body image and overall quality of life (QoL). A pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional acceptance and commitment Therapy (ACT) group based-input and their outcomes monitored over time.
详细描述
Overweight and obesity is reported as an 'epidemic' problem within the UK as well as the world. Individuals living with this may be at higher risk of developing co-morbidities, such as cancers, heart problems or diabetes, and higher mortality rates are reported in this group. Furthermore, overweight and obesity can also impact on a person's psychological wellbeing, such as their self-efficacy, self-esteem and body image as well as have a negative effect on their overall quality of life (QoL). Therefore, a pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional Acceptance and Commitment Therapy (ACT) group based-input.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals will be willing and able to give informed consent for participation in the study;
- •Male or Female, aged 18 years or above.
- •Individuals will have a Body Mass Index (BMI) of over 40 (or over 35 if they are from a black or other minority ethic (BME) group or have a co-existing physical health problem);
- •Individuals will be on a waiting list for a weight loss management programme in the UK;
- •Individuals will have English as a written language.
排除标准
- •Individuals who are currently pregnant or breastfeeding;
- •Individuals with current drug or alcohol abuse, such that would prevent them from engaging in a weight management programme;
- •Individuals who are acutely mentally unwell, such that would prevent them from engaging in a weight management programme;
- •Individuals who at time of referral are at significant risk to themselves of others, such that would prevent them from engaging in a weight management programme;
- •Individuals who are acutely physically unwell and/or hospitalised, such that would prevent them from engaging in a weight management programme;
- •Individuals who have a learning disability or cognitive impairment, such that would prevent them from engaging in a weight management programme.
- •Currently in receipt of psychiatric services.
研究组 & 干预措施
Treatment as usual (weight management intervention)
6 session weight management programme (over 12 weeks).
干预措施: Treatment as usual (dietetic intervention) (Behavioral)
Treatment as usual plus acceptance and commitment therapy
6 session weight management programme (over 12 weeks) plus a 4 session acceptance and commitment therapy (ACT) programme. The ACT part will commence straight after the conclusion of the weight management programme.
干预措施: Acceptance and commitment therapy (Behavioral)
Treatment as usual plus acceptance and commitment therapy
6 session weight management programme (over 12 weeks) plus a 4 session acceptance and commitment therapy (ACT) programme. The ACT part will commence straight after the conclusion of the weight management programme.
干预措施: Treatment as usual (dietetic intervention) (Behavioral)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: 7 days
A measure of psychological distress in relation to anxiety and depression symptoms. There is a total of 14 items (7 items relate to anxiety; 7 items relate to depression) with answers scored on a Likert scale of 0-3 (scores from 0-42; higher scores indicating worse symptoms).
次要结局
- Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)(24 hours)
- Action and Acceptance Questionnaire - II (AAQ-II)(24 hours)
- Eating Self-Efficacy Scale (ESES)(24 hours)
研究者
Sarah Wakefield
Trainee Clinical Psychologist
University of Sheffield