"Diabetes in Balance" - a Randomized Controlled Trial to Evaluate the Effects on Glucose Control, Self-care and Psychosocial Factors?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
For many people living with type 1 diabetes it is a challenge to achieve good glucose control. Barely 20% reaches the goal level and many people experience self-care as complex, demanding and stressful. The purpose of this study is to evaluate the effect of a stress-management program on glucose control, self-care and psychosocial factors. The program is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive behavior therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta hospital will be recruited. Half of them will receive the intervention and the other half will continue with their regular diabetes care. A licensed psychologist specialised in CBT and a diabetes specialist nurse will be leading the intervention that is given in a group format. The program consists of seven 2-hour sessions given over 14 weeks. Glucose control, self care and stress will be measured at inclusion, after session four and seven, at six , 12 and 24 months and finally after 5 years
详细描述
ACT-stress management in type 1 diabetes - a randomized controlled trial to evaluate the effect on glucose control, self-control and psychosocial factors.
Purpose of proposed investigation:
The project hypothesis are that the CBT-intervention will a) improve glucose control, self-care, quality of life and acceptance of diabetes related thoughts and emotions and b) decrease depression, anxiety, general and diabetes related distress and fear of hypoglycemia.
Background information for the project:
The overall goal of diabetes management is to achieve good glycemic control while still maintaining good quality of life and experiencing as few hypoglycemic episodes as possible (the Swedish Social Board of Welfare, 2010). Currently only 19% of people with diabetes reach the goal of 52 mmol/mol for glycemic control (National Diabetes Registry, 2014). Research has proposed difficulties with behavior change (Knight et al., 2006), diabetes related distress (van Bastelar et al., 2010, Fisher et al., 2010) and fear of hypoglycemia (Wild et al., 2007) as important obstacles in achieving the goal. Patient education plays an important role in diabetes care but may not be sufficient in order to reach the recommended treatment goals. The association between knowledge and behavior change is weak and research has suggested that interventions should be more behavior oriented (Knight et al., 2006, Funnell et al., 2008). It is well known that people with chronic disease have an increased risk of developing psychological problems, for instance there are studies showing up to four times higher prevalence of depression in people with type 1 diabetes (Roy & Lloyd, 2012). It is also known that psychological problems are associated with poorer glycemic control, health and quality of life in this group (Chiechanowski et al., 2000; Jacobson, 2004).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Duration of disease >2 years -
- •Hb1c>60 mmol/mol
排除标准
- •Insufficient knowledge to understand and express themselves in Swedish
- •Untreated or severe ongoing psychiatric disease
- •Cortisone treatment
- •Untreated thyroid disease
- •Insulin pump therapy started since <3 months
研究组 & 干预措施
Diabetes in Balance
The intervention consists of the manual-based CBT-group intervention "Diabetes in Balance". It is given in a group format with six to ten participants and consists of 7 sessions. The sessions are given bi-weekly for two hours. Each session has a specific theme such as "Stress and acceptance" "The life-compass; what is important in my life". The participants also conduct assignments related to the themes between the sessions. A licensed psychologist specialised in CBT and a diabetes specialist nurse, both trained in "ACT-stress management" will be leading the intervention group.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Control
The control group receives regular care including regular visits at the out-patient clinic, 3-4 times per year.
结局指标
主要结局
HbA1c
时间窗: 12 months post inclusion
Measure of long term glucose control
次要结局
- Acceptance and action diabetes questionnaire(1-5 years post inclusion)
- The Hypoglycemia Fear Survey emotions, depression, anxiety, fear of hypoglycemia, general and diabetes related distress.(1-5 years post inclusion)
- The Problem Areas in Diabetes (Swe-PAID-20) Scale(1-5 years post inclusion)
- Manchester Short Assessment of Quality of life(1-5 years post inclusion)
- Depression Anxiety stress scales(1-5 years post inclusion)
- The Summary of Self-Care Activities(1-5 years post inclusion)
研究者
Eva Toft
Associate Professor
Karolinska Institutet