The Effects of Acceptance-based Diabetes Education on Diabetes Distress and Glycaemic Control in Adults With Type 2 Diabetes: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change from baseline Diabetes Distress Scale at 3 months post intervention
研究概览
简要总结
This study will evaluate the effectiveness of a structured acceptance-based diabetes education programme for adults with type 2 diabetes compared with those who received diabetes education. The programme mainly comprises acceptance and commitment therapy (ACT) as a psychological component and a diabetes education (DE) component. The short form of the programme is named 'ACT-DE'. This programme aims to decrease the diabetes distress level in participants with type 2 diabetes and improve their blood glucose level. The objectives are:
- To develop an ACT-based intervention protocol as a guide for promoting healthy coping in people with type 2 diabetes who are psychologically distressed.
- To examine the effects of 'ACT-DE' on diabetes distress and HbA1c (primary outcomes) over a three-month follow-up, when compared with diabetes education only.
- To examine the effects of 'ACT-DE' on diabetes self-management behaviours, self-efficacy in diabetes care, and psychological flexibility (secondary outcomes) over the three-month follow-up, when compared with diabetes education; and
- To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants
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.
A pilot study has been conducted earlier (NCT05563987) and showed that a six-week ACT-DE programme (5 sessions) was preliminary effective compared to attending only one session of diabetes education. It was also a feasible and acceptable intervention.
In this main study, a convenience sampling method will be adopted from three out-patient clinics of public hospitals in Hong Kong. A total of 176 eligible participants will be randomly allocated into the intervention (N=88) and the control group (N=88). Participants in the intervention group will receive 6-week ACT-DE programme (5 sessions) composing acceptance and commitment therapy and diabetes education. Each session last for 120 minutes in a group of 8-10 participants. Participants in the control group will receive one session of diabetes education.
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 or 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 consent
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.
研究组 & 干预措施
Acceptance and commitment therapy integrated in diabetes education (ACT-DE)
The proposed intervention is a six-week acceptance-based diabetes education programme (ACT-DE) comprising acceptance and commitment therapy and diabetes education.
Session 1: Diabetes education and introduction of ACT-DE programme Session 2: Mindfulness cultivation Session 3: Value clarification Session 4: Integrating ACT into diabetes self-management Session 5: Booster session Session length: 120 minutes Group-based (6-8 participants) and face-to-face mode of delivery
干预措施: ACT-DE (Behavioral)
Diabetes education
One session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.
干预措施: ACT-DE (Behavioral)
结局指标
主要结局
Change from baseline Diabetes Distress Scale at 3 months post intervention
时间窗: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Diabetes distress will be 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.
Change from baseline HbA1c at 3 months post-intervention
时间窗: Baseline (T0), and 3-month post-intervention (T2)
Blood glucose level of participants will be evaluated with an HbA1c level, which measures the average blood glucose level during the past three months. An HbA1c level over 7% is considered suboptimal glycaemic control, indicating a high risk of diabetes complications.2 HbA1c values obtained every 3-4 months will be collected from the patient electronic information system.
次要结局
- Diabetes self-management behaviours(Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2))
- Diabetes management self-efficacy(Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2))
- Psychological flexibility(Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2))
研究者
Anna Ngan
Principle Investigator
Chinese University of Hong Kong