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

An Online, Compassion Intervention to Improve Shame, Self-criticism, and Physical Wellbeing in Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Four Week Self-Compassion Course

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tunbridge Wells, United Kingdom, TN1 2YG
    • Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Four Week Self-Compassion Course; This is a four-week self-compassion course supplied by Balanced Minds. The owner of Balanced Minds is a Consultant to this study, who will be providing access to participants. 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.; Other Names: Online Self-Compassion Course
No Intervention: Waitlist Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to 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.	Post-intervention (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to 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.	Post-intervention (week 4)
Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to 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.	Post-intervention (week 4)
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to 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.	Post-intervention (week 4)
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and 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.	Post-intervention (week 4)
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and 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.	Post-intervention (week 4)
Change in HbA1c from baseline (week 0) to 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.	Follow-up (week 8)
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).	Please see description above.	Follow-up (week 8)
Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to follow-up (week 8).	Please see description above.	Follow-up (week 8)
Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to follow-up (week 8).	Please see description above.	Follow-up (week 8)
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).	Please see description above.	Follow-up (week 8)
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)	Please see description above.	Follow-up (week 8)
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).	Please see description above.	Follow-up (week 8)

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Investigators: Study Director: Alan Hebben-Wadey, DClinPsy, Canterbury Christ Church University; Principal Investigator: Hetashi Bawa, BSc, MSc, Canterbury Christ Church University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Compassion Intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Hetashi Bawa MRP 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised data would be made available to researchers on reasonable request after the study findings have been published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No