Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Compassion Intervention
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).
Interventions
BEHAVIORALFour 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: 1. The Foundations of Self-Compassion 2. Developing your Compassionate Self 3. Deepening the Compassionate Relationship with Yourself 4. Self-compassion in Everyday Life.
Sponsors
Canterbury Christ Church University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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. |
| 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 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 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 Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8). | Follow-up (week 8) | Please see description above. |
Countries
United Kingdom
Outcome results
None listed