An Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Type 1 Diabetes
• Interventions: Behavioral: Four Week Self-Compassion Course

• Registration Number: NCT05749029
• Lead Sponsor: Canterbury Christ Church University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-01
• Study Start: 2023-05-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• 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.

Exclusion Criteria

• Diagnosis of Gestational Diabetes or Pre-Diabetes.
• Current severe mental health condition;
• Currently self-harming or suicidal;
• Currently engaging in psychological therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Four Week Self-Compassion Course	-

Primary Outcome Measures

Name	Time	Method
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).	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.

Secondary Outcome Measures

Name	Time	Method
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)	The FSCRS is a 22-item scale with statements measuring inadequate self, hated self and reassured self.; Scores will range from 0 to 88.
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)	Follow-up (week 8)	Please see description above.
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).	Post-intervention (week 4)	The FCS is a 15-item measure of fear of compassion towards self.; Scores will range from 0 to 60. Higher scores indicate greater fear of compassion.
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).	Post-intervention (week 4)	The CEAS is a 13-item measure of compassionate engagement and action.; The engagement sub-scale will establish a score between 6 and 60.; The action sub-scale will establish a score between 4 and 40.
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)	Please see description above.
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).	Follow-up (week 8)	Please see description above.
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).	Follow-up (week 8)	Please see description above.
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)	The EISS is an eight-item scale measuring external and internal dimensions of shame.; Higher scores indicate higher levels of shame and a total score varies between 8 and 40.
Change in HbA1c from baseline (week 0) to follow-up (week 8).	Follow-up (week 8)	Participants will be asked to self-report a blood glucose (HbA1c) level taken by a healthcare provider in the past three to six months at baseline and at one-month post-intervention.; Higher HbA1c levels indicate poorer diabetes control.
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).	Post-intervention (week 4)	14-item measure assessing mental wellbeing in the non-clinical sample. Scores on the WEMWBS will range from 14 to 70. Higher scores indicate greater positive mental wellbeing.
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).	Follow-up (week 8)	Please see description above.
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)	Please see description above.

Trial Locations

Locations (1)

Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road; 🇬🇧 Tunbridge Wells, United Kingdom