An Online, Compassion Intervention to Improve Shame, Self-criticism, and Physical Wellbeing in Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Canterbury Christ Church University
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Hetashi Bawa
Trainee Clinical Psychologist
Canterbury Christ Church University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
Time Frame: 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 Outcomes
- 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))
- Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)(Follow-up (week 8))
- Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).(Post-intervention (week 4))
- Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).(Post-intervention (week 4))
- 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))
- Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- 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))
- Change in HbA1c from baseline (week 0) to follow-up (week 8).(Follow-up (week 8))
- Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).(Post-intervention (week 4))
- Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).(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).(Follow-up (week 8))