An Online, Compassion Intervention to Improve Shame, Self-criticism, and Physical Wellbeing in Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
研究概览
简要总结
The goal of this research study is to evaluate a programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.
详细描述
This Randomised Controlled Trial (RCT) will compare a CMT intervention for people with Type 1 and Type 2 Diabetes Mellitus with a waitlist control group who will be given access after the study.
The outcome measures will be completed at baseline (week 0), post-intervention (week 4), and at follow-up (week 8).
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
- Single (Outcomes Assessor)
盲法说明
All the outcome measures will be self-report questionnaires that will be completed by an online automated system with no involvement of the research team.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident in the United Kingdom;
- •Clinician diagnosed Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus;
- •Self-managing condition;
- •Diabetes diagnosed over a year ago.
排除标准
- •Diagnosis of Gestational Diabetes or Pre-Diabetes.
- •Current severe mental health condition;
- •Currently self-harming or suicidal;
- •Currently engaging in psychological therapy.
研究组 & 干预措施
Waitlist Control
Control participants will receive no intervention during the study but will be given the option of accessing the online self-compassion intervention after the study is complete.
Intervention
干预措施: Four Week Self-Compassion Course (Behavioral)
结局指标
主要结局
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
时间窗: Post-intervention (week 4)
The DDS is a 17-item measure of problems and hassles related to diabetes. The DDS establishes a total mean score and a mean score for its four sub-scales. Scores will range from 1 to 6. Mean scores of 3 or above is considered distress worthy of clinical attention.
次要结局
- Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to post-intervention (week 4).(Post-intervention (week 4))
- Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)(Follow-up (week 8))
- Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).(Post-intervention (week 4))
- Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).(Post-intervention (week 4))
- Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to post-intervention (week 4).(Post-intervention (week 4))
- Change in HbA1c from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).(Post-intervention (week 4))
- Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).(Follow-up (week 8))
- Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
研究者
Hetashi Bawa
Trainee Clinical Psychologist
Canterbury Christ Church University