Effectiveness of Mindfulness-informed Intervention for Diabetes-related Outcomes Among Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diabetes Distress Assessment Scale
研究概览
简要总结
The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT), a mindfulness-based psychological approach, can improve health and emotional well-being in adults with type 2 diabetes.
The main questions it aims to answer are:
Can ACT reduce diabetes-related distress?
Can ACT improve self-care behaviors?
Can ACT improve psychological flexibility?
Researchers will compare people who receive ACT to those in a waitlist control group to see if ACT has better effects on diabetes-related outcomes.
Participants will:
Attend ACT sessions tailored for people with type 2 diabetes
Complete questionnaires about their health, mood, and self-care.
详细描述
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder that requires ongoing medical care and self-management to prevent acute complications and reduce the risk of long-term complications. In addition to physical health challenges, many individuals with T2DM experience high levels of diabetes distress (DD), decreased self-efficacy, and difficulties in sustaining recommended lifestyle behaviors. Psychological interventions targeting these factors may enhance both mental and physical health outcomes.
Acceptance and Commitment Therapy (ACT), a third-wave behavioral therapy, emphasizes mindfulness, acceptance of internal experiences, and commitment to value-driven action. ACT aims to increase psychological flexibility - the ability to remain engaged in meaningful activities even when faced with difficult thoughts, emotions, or physical sensations. Although ACT has shown efficacy for various chronic illnesses, there is limited evidence from randomized controlled trials (RCTs) in Pakistan, and none to date for T2DM populations in this setting.
This randomized controlled trial will evaluate the effectiveness of a culturally adapted, group-based ACT program for adults diagnosed with T2DM. The primary objectives are:
To determine whether ACT reduces diabetes distress.
To assess whether ACT improve diabetes self-care behaviors, diabetes distress, diabetes self efficacy, psychological flexibility, self-compassion, coping and perceived social support
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having diagnosis of type 2 diabetes at least since one year and having moderate to high diabetes distress.
排除标准
- •Psychosis, Dementia, Terminal Renal failure or other life threatening condition
结局指标
主要结局
Diabetes Distress Assessment Scale
时间窗: Before intervention and after six weeks of intervention
It is a five point liker scale where "5" means there is a "serious problem" and 1 means "there is a not a problem". high score indicates greater level of diabetes distress.
Summary of Diabetes-Self-care activity
时间窗: Before intervention and after six weeks of intervention
It is 15 item scale to measure diabetes self-care practices. It is based on number of activities being performed the last week. Therefore response scale is from 0 till 7. where "0" means this particular self care activity has not been performed in the last week and "7" means it has been performed every day. Higher the score, higher the number of diabetes self-care practices performed last week. These include diet, blood glucose testing, Exercise, Foot care and Medications.
次要结局
- Brief Coping Inventory(Before intervention and after six weeks of intervention)
研究者
Faiza Batool
Lecturer
National University of Modern Languages