Feasibility of a Tailored Online Self-compassion Intervention

Official title

A Feasibility Randomised Controlled Trial of Online Self-compassion Training Tailored for Adults Living With Type 1 and Type 2 Diabetes Mellitus

Overview

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.

Detailed description

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.

Interventions

• Behavioral Feasibility RCT of a tailored online self-compassion intervention
  This is a four-week online self-compassion course supplied by Balanced Minds. The researches of this study and an Expert by Experience have consulted with the owner of Balanced Minds to tailor this programme to people with diabetes. The self-help, self-compassion course is based on Compassionate Mind Training. This provides participants with opportunities to develop skills and attributes of compassion through a weekly 30-minute video on a specified topic, a 10-minute compassionate exercise that

Primary outcome measures

• Number of participants recruited [Time frame: 6 months following the start of recruitment]
• Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions [Time frame: Weeks 2 to 8]
• Proportion of study participants who remain in the study [Time frame: Weeks 0 to 10]
• Compassion training course acceptability [Time frame: Weeks 9 to 10]
• Completion rate of the outcome measures [Time frame: Weeks 0 to 10]
• 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). [Time frame: Weeks 9 - 10]

Secondary outcome measures (3)

• 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). [Time frame: Weeks 9-10]
• 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). [Time frame: 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). [Time frame: Weeks 9-10]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United Kingdom · 2 centers

• Betsi Cadwaladr University Health Board (BCUHB) — Bangor
• Barts Health NHS Trust — London

Publications

• Banks J, Amspoker AB, Vaughan EM, Woodard L, Naik AD. Ascertainment of Minimal Clinically Important Differences in the Diabetes Distress Scale-17: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342950. doi: 10.1001/jamanetworkopen.2023.42950. PMID 37966840

Identifiers

NCT: NCT07051005 · ETH2425-0223

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗