Tailored four-week online self-compassion program for adults with diabetes
A Feasibility Randomised Controlled Trial of Online Self-compassion Training Tailored for Adults Living With Type 1 and Type 2 Diabetes Mellitus
This four-week online self-compassion program is being tested to see if it reduces diabetes-related distress and improves wellbeing for adults with Type 1 or Type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Canterbury Christ Church University Academic / other |
| Locations | 2 sites (Bangor, Wales and 1 other locations) |
| Trial ID | NCT07051005 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial will randomize adults with Type 1 or Type 2 diabetes to a tailored four-week online Compassionate Mind Training course or to a waitlist control who receive the course later. Four self-report measures will be completed online at baseline (weeks 0–1) and after the intervention (weeks 9–10). The trial will focus on feasibility and acceptability metrics such as recruitment ease, participant retention in the intervention and study, completion of outcome measures, and acceptability ratings. Investigators will also look for a preliminary signal of efficacy on the primary outcome of diabetes distress to determine whether to progress to a full-scale RCT.
Who should consider this trial
Good fit: Adults aged 18 or older with a clinician-diagnosed Type 1 or Type 2 diabetes for more than one year, who are self-managing their condition, identified by their NHS team as needing support for diabetes-related distress, able to read English, and with reliable internet access are ideal candidates.
Not a fit: People currently in a mental health crisis (including severe depression, active suicidal thoughts, acute psychosis), those with severe substance abuse, gestational or rare forms of diabetes, those unable to read English, or without reliable internet access are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could reduce diabetes-related distress and self-criticism and provide a scalable online option to support mental wellbeing for people living with diabetes.
How similar studies have performed: Prior small trials of self-compassion and Compassionate Mind Training have shown promising improvements in distress and wellbeing, but tailored online CMT specifically for people with diabetes remains relatively novel and untested in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * \<18 * 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).
Where this trial is running
Bangor, Wales and 1 other locations
- Betsi Cadwaladr University Health Board (BCUHB) — Bangor, Wales, United Kingdom (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Jodie Slevin, BSc — Canterbury Christ Church University
- Study coordinator: Jodie Slevin, BSc
- Email: js1624@canterbury.ac.uk
- Phone: +4407539333552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.