Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Diabetes distress
研究概览
简要总结
This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.
详细描述
This study tests the effects of a 12-week mindful self-compassion (MSC) program in people with type 1 diabetes. Eighty participants will be randomized to the MSC program or be in a wait-list control group. Measures of primary outcome are self-compassion and diabetes- distress. Secondary outcomes are hemoglobin A1C, diabetes self-efficacy, stress and depression symptoms, and sleep quality. Outcomes will be measured at baseline, 12 weeks (end of the program) and 24 weeks (post program).
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes, age 18-30
- •own computer or tablet with access to internet for meetings
- •willingness to complete all 6 sessions
- •Exclusion criteria:
- •history of self-harm or suicide attempt in the pat one year
- •severe diabetic complications such as dialysis or blindness
- •unstable depression, requiring ongoing medication adjustment within the last 3 months
- •A1C > 11%
- •Severe hypoglycemia requiring emergency room visit or hospitalization in the past 6 months
- •History of Diabetic Ketoacidosis requiring hospitalization in the past 3 months
- •pregnant or intend to get pregnant during the study timeframe
排除标准
- 未提供
结局指标
主要结局
Diabetes distress
时间窗: baseline to 24 weeks
Diabetes distress will be evaluated by a questionnaire. Each item is rated on a 6-point Likert scale from 1 (no problem) to 6 (serious problems). Scores range from 17 to 102, which the higher scores indicate the higher diabetes distress levels (A worse outcome).
Self-compassion
时间窗: baseline to 24 weeks
Self-compassion will be evaluated by a questionnaire. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores range from 26 to 130, which the higher scores indicate the higher self-compassion levels (A better outcome). This outcome is reported in the mean difference of self-compassion score between two groups.
次要结局
- Stress and depressive symptoms(baseline to 24 weeks)
- Diabetes Self-efficacy(baseline to 24 weeks)
- Hemoglobin A1C(baseline and 12 weeks)
- Sleep quality(baseline to 24 weeks)
研究者
Ratanaporn Jerawatana
Principal Investigator
Mahidol University