跳至主要内容
临床试验/NCT02130596
NCT02130596已完成不适用

A Pilot Study of an Acceptance-Based Behavioral Intervention Versus Nutritional Counseling for Weight Loss in Psychotic Illness

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年2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
16
试验地点
2
主要终点
Weight (kg)

研究概览

简要总结

Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time.

Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 25.0
  • Diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified).

排除标准

  • Inability to provide informed consent
  • Prediabetes or type 2 diabetes mellitus
  • Current enrollment in another formal weight management program
  • Brief Psychiatric Rating Scale (BPRS) ratings of 4 or more on any one of Grandiosity (Item #6), Suspiciousness (Item #7), Hallucinations (Item #8), Unusual Thought Content (Item #9), or Conceptual Disorganization (Item #10), or a BPRS total score of 80 or more.

研究组 & 干预措施

Acceptance-Based Behavioral Intervention

Experimental

干预措施: Acceptance-Based Behavioral Intervention (Behavioral)

Nutritional Counselling

Active Comparator

干预措施: Nutritional Counselling (Other)

结局指标

主要结局

Weight (kg)

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

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

Rohan Ganguli

Senior Scientist, Canada Research Chair

Centre for Addiction and Mental Health

研究点 (2)

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