A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in diabetes distress score using T1-DDS
研究概览
简要总结
The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.
The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.
The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.
The main research questions are:
- Does a group-based psychological intervention reduce diabetes distress?
- Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?
Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).
Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 6 months
- •Age between 18 and 35
- •T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2
- •Treated in a diabetes clinic in the Region of Southern Denmark
- •Proficient in Danish
排除标准
- •Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention
- •Cognitive disorders such as brain injury
- •Complex challenges best suited to individual treatment
- •Current therapeutic treatment for depression, anxiety or stress
- •Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period
结局指标
主要结局
Change in diabetes distress score using T1-DDS
时间窗: from baseline to 3 months
The primary outcome, is a reduction in the degree of diabetes distress measured using the Type 1 Diabetes Distress Scale (T1-DDS). The scale uses a 6 point likert-scale. The combined DDS score is divided by 28 to give a number between 1 and 6. A score between 2,00-2,99 is defined as moderate diabetes distress, and a score above 3,00 is defined as high diabetes distress.
次要结局
- Change in GAD-7 score(from baseline to 3 months)
- Change in the T1-DDAS score(from baseline to 3 months)
- Change in PHQ-9 score(from baseline to 3 months)
- Change in AADQ score(from baseline to 3 months)
- Change in HbA1c(from baseline to 3 months)