跳至主要内容
临床试验/NCT01508585
NCT01508585已完成不适用

Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study

University Health Network, Toronto0 个研究点目标入组 47 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
主要终点
Changes in Depression severity

研究概览

简要总结

Bariatric surgery is the most effective treatment for patients with extreme obesity. Psychological interventions are not routinely offered in Bariatric Surgery Programs. Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in reducing binge eating and improving surgical outcomes. The current study will examine whether the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more effective than the usual standard of care alone, and whether it is more effective when delivered prior to or following bariatric surgery.

详细描述

Preliminary research suggests that CBT might be effective in reducing eating pathology and improving surgical outcomes.

However, previous studies have examined group-based CBT delivered in person, and most patients cannot feasibly attend weekly therapy appointments at the hospital. Telephone-based CBT offers greater convenience because the service can be delivered during the evening and weekends, and eliminates the need to leave work and travel to hospital appointments. No published studies have examined the effectiveness or feasibility of telephone-based CBT for bariatric surgery patients. This study will examine the effectiveness of Tele-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.

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

入选标准

  • Fluent in English
  • Have access to telephone and computer with internet access
  • Have the capacity to provide informed consent

排除标准

  • Active suicidal ideation
  • Serious mental illness
  • Active severe depression
  • Active severe anxiety
  • Active post traumatic stress disorder

结局指标

主要结局

Changes in Depression severity

时间窗: Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery

Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity

Changes in Anxiety severity

时间窗: Baseline, post-intervention, 6 months, and one year after bariatric surgery

Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity

Changes in Health-related quality of life

时间窗: Baseline, post-intervention, 6 months, and one year after bariatric surgery

Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.

Changes in eating pathology

时间窗: Baseline, post-intervention, 6 months, and 1 year after bariatric surgery

Measured by the "Binge Eating Scale" (BES) and "Emotional Eating Scale" (EES). The BES is a 16-item self-report measure designed specifically for use with obese individuals that assesses binge eating behaviors as well as associated cognitions and emotions. The EES is a 25-item self-report measure that assesses the tendency to cope with negative affect by eating.

次要结局

  • Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery(One year follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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