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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Four Week Self-Compassion Course | Behavioral | 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:
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Hebben-Wadey, DClinPsy | Canterbury Christ Church University | Study Director |
| Hetashi Bawa, BSc, MSc | Canterbury Christ Church University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road | Royal Tunbridge Wells | Tunbridge Wells | TN1 2YG | United Kingdom |
Anonymised data would be made available to researchers on reasonable request after the study findings have been published.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| 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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |