跳至主要内容
临床试验/NCT01473017
NCT01473017撤回不适用

Improving Mental Health in Diabetes: A Guided Self-Help Study

University of Edinburgh2 个研究点 分布在 1 个国家开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Anxiety and/or depression in Type 2 Diabetes

研究概览

简要总结

This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.

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

入选标准

  • Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.

排除标准

  • Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.
  • Participants with a known Learning Disability or severe visual impairment.
  • Participants who cannot read or write
  • Participants under 18 years of age or over age 75
  • Long-term hospital inpatients
  • Individuals with a diagnosis of Diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)

结局指标

主要结局

Anxiety and/or depression in Type 2 Diabetes

时间窗: 18 weeks

To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes

次要结局

  • Quality of life(18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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