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
- 2
- 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
排除标准
- •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
研究组 & 干预措施
Mindful Self-Compassion
Participants will meet every 2 weeks via zoom application or equivalent online meeting platforms, for 12 weeks. The sessions will be led by a clinical psychologist. The curriculum will follow mindful compassion program by Neff KD
干预措施: Mindful Self-Compassion (Behavioral)
Wait List Control
Wait list control group will not participate in the MSC program during the first 12 weeks of the protocol but will be given an opportunity to participate after 12 weeks, using the same curriculum.
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