Clinical trial NCT05749029: An Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).
Official title: An Online, Compassion Intervention to Improve Shame, Self-criticism, and Physical Wellbeing in Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Compassion Intervention
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
timeFrame: Post-intervention (week 4)
Secondary outcomes:
measure: Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to post-intervention (week 4).
timeFrame: Post-intervention (week 4)
measure: Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to post-intervention (week 4).
timeFrame: Post-intervention (week 4)
measure: Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).
timeFrame: Post-intervention (week 4)
measure: Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).
timeFrame: Post-intervention (week 4)
measure: Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).
timeFrame: Post-intervention (week 4)
measure: Change in HbA1c from baseline (week 0) to follow-up (week 8).
timeFrame: Follow-up (week 8)
measure: Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).
timeFrame: Follow-up (week 8)
measure: Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to follow-up (week 8).
timeFrame: Follow-up (week 8)
measure: Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to follow-up (week 8).
timeFrame: Follow-up (week 8)
measure: Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).
timeFrame: Follow-up (week 8)
measure: Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)
timeFrame: Follow-up (week 8)
measure: Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).
timeFrame: Follow-up (week 8)
Other outcomes:
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road
Study officials:
affiliation: Canterbury Christ Church University
name: Alan Hebben-Wadey, DClinPsy
role: STUDY_DIRECTOR
affiliation: Canterbury Christ Church University
name: Hetashi Bawa, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: