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临床试验/NCT00564070
NCT00564070已完成不适用

CBT for Adherence and Depression in Diabetes

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2007年6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
87
试验地点
2
主要终点
Glucose Monitoring Adherence at Acute Outcome

研究概览

简要总结

This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.

详细描述

Depression is a serious illness that affects a person's mood, thoughts, and physical being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression is highly comorbid, often occurring in the presence of one or more other disorders. Up to 15% to 20% of the time, people with diabetes are also depressed. Diabetes is a disease that interferes with the body's proper production and use of the hormone insulin, which is needed to convert food into the energy required to perform daily life activities. Self-care is a crucial component of diabetes treatment. However, symptoms of depression can interfere with behaviors necessary to carry out this care. Cognitive behavioral therapy (CBT) has shown success in treating people with depression, but the effect of CBT on self-care behaviors and depression of those with diabetes is not well known. This study will evaluate the effectiveness of CBT for medical adherence and depression (CBT-AD) in people with a depressive mood disorder and type 2 diabetes.

Upon study entry, all participants will complete various assessments, including a psychiatric diagnostic interview, a series of paper questionnaires, neuropsychological testing, blood sample analysis, and blood sugar monitoring. Next, all participants will meet with a nutritionist and a nurse diabetes educator. The nutritionist will help set goals for eating, physical activity, weight, and blood glucose. The nurse diabetes educator will review diabetes medication history and blood glucose self-monitoring equipment.

Participants will then be randomly placed in one of two counseling groups. One group will meet for a single session that will be devoted to diabetes medical adherence. The other group will attend 10 to12 individual CBT sessions for diabetes medical adherence and depression management. The CBT sessions will last 45 to 50 minutes and will require practice of coping skills outside the sessions. Participants receiving CBT will also complete weekly assessments of depression, self-care, and diabetes medical adherence. All participants will be asked to monitor a prescribed medication with a pill cap for the course of the study. At Month 2, participants in both groups will also meet again with the nutritionist to review original goals and adjust them as necessary. Most of the previous study assessments will be repeated at Months 4, 8, and 12. The neuropsychological testing will be repeated only at Month 12.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both
  • Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant
  • If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months

排除标准

  • Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
  • Experiencing suicidal thoughts
  • History of or currently receiving CBT for depression
  • Uses an insulin pump

研究组 & 干预措施

Enhanced treatment as usual

Active Comparator

Enhanced treatment as usual plus single-session life-steps treatment

干预措施: Enhanced treatment as usual plus adherence training (Behavioral)

CBT-AD

Experimental

Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)

干预措施: Enhanced treatment as usual plus CBT-AD (Behavioral)

结局指标

主要结局

Glucose Monitoring Adherence at Acute Outcome

时间窗: Measured at Month 4

Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.

Percent Medication Adherence Via MEMS

时间窗: month 4

This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence

Clinician Rated Depression (MADRS) at the Acute Timepoint

时间窗: month 4

Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.

Depression on the CGI at Acute Outcome

时间窗: Month 4

Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression

次要结局

  • Glucose Control(Month 4)

研究者

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

Steven A. Safren

Director, Behavioral Medicine

Massachusetts General Hospital

研究点 (2)

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