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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Four Week Self-Compassion Course


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Four Week Self-Compassion Course<br>* 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.<br>* Other names: Online Self-Compassion Course;|
| No Intervention: Waitlist Control<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compassion Intervention