A Feasibility Randomised Controlled Trial of Online Self-compassion Training Tailored for Adults Living With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants recruited
研究概览
简要总结
The goal of this clinical trial is to examine the feasibility and acceptability of an online 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 pilot randomised controlled trial seeks to examine the feasibility and acceptability of online compassion training tailored for adults living with Type 1 and Type 2 diabetes. Participants will be randomised to either the compassion training course or a waitlist control group, in which participants will be offered the intervention at the end of the study. Four self-report measures will be administered online at baseline (weeks 0-1) and post-intervention (weeks 9-10). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (diabetes distress). These indices will be compared to progression criteria which determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older.
- •Diagnosed with Type 1 or Type 2 diabetes by a clinician in the NHS more than one year ago.
- •Self-managing theircondition.
- •Identified by their NHS team as needing support with their mental health due to diabetes-related distress.
排除标准
- •Individuals experiencing a current mental health crisis, including severe depression, active suicidal thoughts, or acute psychosis
- •Unable to read/speak English
- •Gestational diabetes, Wolfram, and other rarer conditions
- •Individuals currently experiencing severe substance abuse issues that could interfere with participation in the programme
- •Individuals without reliable access to the internet and a compatible device (computer or smartphone).
结局指标
主要结局
Number of participants recruited
时间窗: 6 months following the start of recruitment
The number of participants recruited over 6-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: \<24.
Proportion of study participants who remain in the study
时间窗: Weeks 0 to 10
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: \<25%.
Estimate of between group effect size of the compassion training course intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9 - 10).
时间窗: Weeks 9 - 10
The estimated between group effect size of the compassion training intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9-10) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: effect size in favour of intervention arm and 95% confidence interval for that effect size contains (or is greater than) the minimal clinically important difference (MCID) found in previous research (0.25 or greater). Amber: effect size is in favour of control, but the minimum clinically important difference is included in the 95% confidence interval; Red: effect size is in favour of control, and the minimum clinically important difference is not included in the 95% confidence interval.
Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions
时间窗: Weeks 2 to 8
The proportion of participants who completed at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: \<25%.
Compassion training course acceptability
时间窗: Weeks 9 to 10
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed.
Completion rate of the outcome measures
时间窗: Weeks 0 to 10
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measure completion: Green: ≥60%; Amber 40-59%; Red: \<40%.
次要结局
- Estimate of the between group effect size of compassion training intervention compared to control on change in the External and Internal Shame Scale (EISS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).(Weeks 9-10)
- Estimate of the between group effect size of compassion training intervention compared to control on change in the Forms of Self-Criticising/ Attacking & Self-Reassuring (FSCRS) Scale from baseline (weeks 0-1) to post-intervention (weeks 9-10).(Weeks 9-10)
- Estimate of the between group effect size of compassion training intervention compared to control on change in the Compassionate Engagement and Action Scale (CEAS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).(Weeks 9-10)