Mindfulness-based Cognitive Therapy (MBCT) for Type II Diabetes Mellitus (DM) Patients With High Diabetes Distress and Suboptimal DM Control: a Pilot Qusai-experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of recruitment
研究概览
简要总结
Background: Diabetes-related distress (DRD) is very common among people with type II diabetes mellitus (DM). DRD led to poorer DM control and may led to adverse prognosis. Yet, there is no widely accepted or recommended DRD treatment.
Mindfulness was shown to relieve psychological distress in various physical and mental conditions.
Aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (MBCT), which is one of the widely used mindfulness program, is feasible and acceptable and may improve DRD in our Chinese population.
Method: 20 Chinese participants with suboptimally controlled DM and high DRD will be recruited to a 8- week MBCT group. Pre-group and post-group (immediate and 2-month post-group) data including DRD score, quality-of life measures will be compared.
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
- 否
入选标准
- •received a clinical diagnosis of type II DM
- •aged >=18
- •can provide valid consent
- •can speak Cantonese
- •can read and write simple Chinese
- •HbA1c >7%
- •have CDDS score >=3
排除标准
- •diagnosed active mental illness
- •have severe hearing loss
- •non-Chinese
- •have active suicidal ideation as screened by Q9 of PHQ-9
- •unwilling to join at least 6 out of 8 session of MBCT
- •received mindfulness training in the past year or having regular mindfulness practice
- •received psychotherapy last year
- •severe physical illness limiting them from coming repeatedly to the group
研究组 & 干预措施
MBCT arm
8-week MBCT program
干预措施: Mindfulness-based cognitive therapy MBCT (Behavioral)
结局指标
主要结局
Rate of recruitment
时间窗: From recruitment (1 April) till 20 patients are recruited (within 1 month)
As a pilot study, we like to determine if it is feasible to recruit the target patients and measure the relevant outcomes. The number of patient approached and the number of patient recruited will be recorded
Dropout rate
时间窗: Week 1 (start of MBCT, intervention) till week 8
The proportion of patients attending at least 6 out of 8 classes
次要结局
- Chinese Version of Diabetes Distress Scale (CDDS-15)(At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16))
- The Audit of Diabetes-Dependent Quality of Life (ADDQOL)(At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16))
- 9-item patient Health Questionnaire (PHQ-9)(At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16))
研究者
Lee Kam Pui
Clinical assistant professor
Chinese University of Hong Kong