CBT for Adherence and Depression in Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes in glucose monitoring
研究概览
简要总结
This study is a pilot behavioral intervention trial, designed to initially examine cognitive behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression and poorly controlled type 1 diabetes.
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
- 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
- 否
入选标准
- •Diagnosis of type 1 diabetes that is poorly controlled (HbA1C greater than or equal to 8.0%) despite treatment with insulin.
- •Diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
- •If on an antidepressant, stable for two months. Oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).
排除标准
- •Active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
- •Unable or unwilling to provide informed consent.
- •History of or current CBT for depression.
- •Currently on dialysis.
结局指标
主要结局
Changes in glucose monitoring
时间窗: Baseline assessment; 4, 8, and 12 months post-intervention assessments
We used electronic glucometers to measure participants' adherence to prescribed glucose self-monitoring, which record each time glucose was measured and the glucose level of each measurement.
Changes in insulin adherence
时间窗: Baseline assessment; 4, 8, and 12 months post-intervention assessments
We assessed adherence to participants' self-administered insulin through a self-report questionnaire.
Changes in depression severity
时间窗: Baseline assessment; 4, 8, and 12 months post-intervention assessments
Participants' depression severity was measured by clinician-administered measures (Montgomery-Asberg Depression Rating Scale) and self-report measures (Center for Epidemiological Studies Depression Scale). Clinician-delivered measures were administered at baseline and follow-up assessments by assessors blinded to participants' randomization status.
次要结局
- Changes in hemoglobin A1C(Baseline assessment; 4, 8, and 12 months post-intervention assessment)
- Changes in glucose levels(Baseline assessment; 4, 8, and 12 months post-intervention assessment)
研究者
Steven A. Safren
Director, Behavioral Medicine
Massachusetts General Hospital