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临床试验/NCT02920112
NCT02920112已完成不适用

Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)

研究概览

简要总结

This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the usual standard of care in bariatric surgery patients. Participants one year post-surgery will receive six sessions of Tele-CBT and complete measures before, during, immediately after, and one year after participation in the study.

详细描述

Obesity is an increasingly prevalent chronic condition (Ogden et al., 2006) which is associated with significant health consequences, including type 2 diabetes, obstructive sleep apnea, hypertension, and hyperlipidemia (Bray, 2004). Bariatric surgery is the most effective treatment for patients with extreme obesity (Colquitt et al., 2005). Unfortunately, it has been estimated that 20 to 50% of patients begin to regain their weight within the first 1 ½ to 2 years, and improvements in medical comorbidities dissipate with weight regain (Hsu et al., 1998; Shah et al., 2006). In light of the high relapse rates following bariatric surgery, research on non-surgical factors that influence the outcome of bariatric surgery, such as psychiatric comorbidity, has become increasingly important (Hsu et al., 1998). Up to 55% of bariatric surgery candidates have an Axis I disorder at the time of the initial assessment, with the most common diagnoses being eating disorders (37%), affective disorders (32%), and anxiety disorders (15%) (Muhlhans et al., 2009). Despite accumulating evidence indicating that psychiatric comorbidity is associated with poorer surgical outcomes, psychological interventions are not routinely offered in Bariatric Surgery programs. It has been suggested that cognitive behavioural therapy (CBT) could be helpful in maintaining weight loss (Kalarchian & Marcus, 2003). We have published a paper on the feasibility of the protocol using a small sample and producing promising eating improvements post-intervention (Cassin et al., 2013). A more recent study (Cassin et al., 2016) of the first phase of this study with Tele-CBT delivered 6 months before surgery indicated significant improvements in binge eating, emotional eating, and depressive symptoms, compared to a control group. These results are similar to other studies employing CBT for bariatric surgery patients (e.g. Gade et al., 2014). We have recently published on the outcomes for Tele-CBT delivered 6 months post-surgery (Sockalingam, Cassin, Wnuk, Du, Jackson, Hawa, & Parikh, 2016) that showed significant reductions in scores of binge eating, emotional eating, depression, and anxiety. The same measures used in the first phase of the study (Cassin et al., 2016; Sockalingam et al., 2016) will be used in this second phase, looking at Tele-CBT delivered to patients at one year after surgery. Comparisons between the efficacy of Tele-CBT based on responses to measures will be made for participants receiving the intervention at 6 months before surgery, 6 months after surgery, and 1 year after surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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 a telephone and a computer with internet connection.
  • Have the capacity to provide informed consent.
  • Patient is at approximately one year post-surgery at the Bariatric Surgery Program at Toronto Western Hospital.

排除标准

  • Active suicidal ideation.
  • Active serious mental illness
  • Active severe depression
  • Active severe anxiety
  • Active symptoms of post-traumatic stress disorder

研究组 & 干预措施

One year post-op Tele-CBT

Experimental

This group will receive Telephone based Cognitive Behavioral Therapy (Tele-CBT) one year after bariatric surgery.

干预措施: Telephone based Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)

时间窗: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

41-item self-report measure that assesses eating disorder psychopathology. Only 3 items regarding binge eating will be used. Will be used to measure changes in eating pathology.

Changes in Eating Pathology: Binge Eating Scale (BES)

时间窗: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

Changes in Eating Pathology: Ontario Bariatric Eating Self-Efficacy Scale (OBESE) - Changes in Eating Pathology

时间窗: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

28-item self-report measure of eating self-efficacy in bariatric patients.

Changes in Eating Pathology: Emotional Eating Scale (EES)

时间窗: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,

25-item self-report measure that assesses tendency to cope with negative affect by eating.

次要结局

  • Changes in Health-Related Quality of Life(Baseline pre-intervention, immediately post-intervention, and 1 year after intervention)
  • Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)(Weekly up to 6 weeks during intervention and immediately post-intervention)
  • Changes in Anxiety Severity(Baseline pre-intervention, immediately post-intervention, and 1 year after intervention)
  • Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)(Weekly up to 6 weeks during intervention and immediately post-intervention)
  • Changes in Depression Severity(Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention)
  • Satisfaction with Therapy: Tele-CBT Client Change Interview(Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjeev Sockalingam

Deputy Psychiatrist-in-Chief

University Health Network, Toronto

研究点 (2)

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