Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received bariatric surgery 1 year ago
- •Fluent in English
- •Have Internet access to complete online questionnaires.
排除标准
- •Current active suicidal ideation
- •Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire [PHQ-9]61 score > 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder [GAD-7]62 score >15)
- •Current poorly controlled medical illness that would render Tele-CBT very difficult.
结局指标
主要结局
Change in Weight
时间窗: 1.25, 1.5, 2, 3 years post-surgery
Change in weight measured in kg
次要结局
- Changes in obesity-related medical comorbidities - Medication Burden(2 and 3 years post-surgery)
- Changes in obesity-related medical comorbidities - T2DM(2 and 3 years post-surgery)
- Changes in obesity-related medical comorbidities - Medical Treatments(2 and 3 years post-surgery)
- Changes in eating pathology - Depression(1.25, 1.5, 2, and 3 years post-surgery)
- Changes in eating pathology - Quality of Life(1.25, 1.5, 2, and 3 years post-surgery)
- Changes in eating pathology - Binge Eating(1.25, 1.5, 2, and 3 years post-surgery)
- Changes in eating pathology - Loss of Control(1.25, 1.5, 2, and 3 years post-surgery)
- Changes in eating pathology - Emotional Eating(1.25, 1.5, 2, and 3 years post-surgery)
- Changes in eating pathology - Anxiety(1.25, 1.5, 2, and 3 years post-surgery)
研究者
Sanjeev Sockalingam
Deputy Psychiatrist-in-Chief
University Health Network, Toronto