Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005 | Recruiting

• 1 other identifier: ETH2425-0223
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes; Online intervention; Compassion; Feasibility RCT

Outcome Measures

Primary Outcomes (6)

• Number of participants recruited

  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.

  6 months following the start of recruitment

• Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions

  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%.

  Weeks 2 to 8

• Proportion of study participants who remain in the study

  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%.

  Weeks 0 to 10

• Compassion training course acceptability

  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.

  Weeks 9 to 10

• Completion rate of the outcome measures

  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%.

  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).

  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.

  Weeks 9 - 10

Secondary Outcomes (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).

  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).

  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

Study Arms (2)

Online Intervention

EXPERIMENTAL

Four Week Online Self-Compassion Course

Behavioral: Feasibility RCT of a tailored online self-compassion intervention

Waitlist Control

NO INTERVENTION

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.

Interventions

Feasibility RCT of a tailored online self-compassion intervention BEHAVIORAL

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 participants are encouraged to engage in daily for the week and a brief summary of the compassionate topic. The topics of the course are: The Foundations of Self-Compassion Developing your Compassionate Self Deepening the Compassionate Relationship with Yourself Self-compassion in Everyday Life.

Online Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Canterbury Christ Church University: lead
• Barts & The London NHS Trust: collaborator
• Betsi Cadwaladr University Health Board: collaborator

Study Sites (2)

Betsi Cadwaladr University Health Board (BCUHB)

Bangor, Wales, LL57 2PW, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 2ES, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• 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 RESULT

Related Links

• Diabetes Distress - Screening Scale (DDS17)
• The Forms of Self-Criticising/ Attacking \& Self-Reassuring Scale (FSCRS)
• Compassionate Engagement and Action Scale (CEAS)
• External and Internal Shame Scale (EISS)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fergal Jones, PhD

  Canterbury Christ Church University

  STUDY CHAIR

• Alan Hebben-Wadey, DClinPsy

  Canterbury Christ Church University

  STUDY DIRECTOR

• Jodie Slevin, BSc

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodie Slevin, BSc

CONTACT

+4407539333552; js1624@canterbury.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 3, 2025
• Study Start: June 18, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-06

Locations

GB (2)