The Effects of an Acceptance-based Diabetes Education (ACT-DE) Programme for Adults With Type 2 Diabetes on Diabetes Distress: a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Diabetes Distress Scale
研究概览
简要总结
This study is a pilot RCT to examine the feasibility, acceptability and preliminary effectiveness of a 6-week acceptance-based diabetes education programme (ACT-DE) on diabetes distress, self-care efficacy and behaviours of adults with type 2 diabetes in Hong Kong.
It is hypothesise that the ACT-DE programme will:
- Be acceptable, feasible and beneficial for adults with type 2 diabetes to improve their psychological distress and self-care.
- Significantly reduce participants' diabetes distress (primary outcomes), when compared with the usual care (control) group immediately post-intervention;
- Significantly improve self-care efficacy, self-care behaviour and psychological flexibility (secondary outcomes) than the control group immediately post-intervention.
详细描述
Diabetes distress is an aversive feeling and emotional disturbance specific to diabetes, including the burden of daily self-care, worry and guilty feelings, and low satisfaction level with health care professionals. Around 36% of people with type 2 diabetes worldwide suffered from diabetes distress, which is associated with poor self-care performance, low self-efficacy in diabetes management and higher blood glucose levels. Acceptance and Commitment Therapy, one of the mindfulness and acceptance-based interventions, integrated with diabetes education are found to be potentially effective interventions for reducing diabetes distress.
Participants who agreed to participate in the study were randomly allocated into the intervention (N=24) and the control group (N=24). Participants in the intervention group received a 6-week group-based acceptance and commitment therapy integrated with diabetes education (ACT-DE). There were five sessions in 6 weeks with 120 minutes per session. The group size were 6. While participants in the control group received one session of diabetes education without any information on acceptance and commitment therapy.
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)
盲法说明
The outcome assessor who is responsible for collecting outcome data and data entry has no idea about the group allocation of participants.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community-dwelling adults Hong Kong Chinese residents,
- •aged 18-64,
- •diagnosed with type 2 diabetes for over one year;
- •at least moderate level of diabetes distress as measured with the Chinese Diabetes Distress Scale (CDDS-15; mean score >2 per item);
- •having suboptimal blood glucose control as shown by HbA1c level of ≥ 7% in the laboratory results within the past six months;
- •able to communicate in Cantonese and give written content.
排除标准
- •history of a clinically diagnosed mental illness such as depression and anxiety disorder, and/or an acute/severe medical disease;
- •noticeable cognitive impairment(s) as indicated by the total score (<6 of 10) of the Abbreviated Mental Test;
- •recently received/receiving any psychological therapy such as mindfulness or acceptance-based therapy.
结局指标
主要结局
Change in Diabetes Distress Scale
时间窗: baseline (T0) and immediate post-intervention (T1)
Diabetes distress was measured by the Chinese 15-item Diabetes Distress Scale (CDDS-15). It consists of 15 items rated on a six-point Likert scale from 1 = 'not a problem' to 6 = 'a serious problem'. A mean item score of 2-2.9 and ≥3.0 indicates moderate and severe distress, respectively.
次要结局
- Psychological flexibility(baseline (T0) and immediate post-intervention (T1))
- Diabetes management self-efficacy(baseline (T0) and immediate post intervention (T1))
- Diabetes self-management behaviours(baseline (T0) and immediate post-intervention (T1))
研究者
Anna Ngan
Principle Investigator
Chinese University of Hong Kong