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

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749029
• Other study ID #: Hetashi Bawa MRP 2021
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2024
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 12, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Behavioral:
• Four 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: The Foundations of Self-Compassion Developing your Compassionate Self Deepening the Compassionate Relationship with Yourself Self-compassion in Everyday Life.

Locations

Country	Name	City	State
United Kingdom	Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road	Tunbridge Wells

Sponsors (1)

Lead Sponsor	Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).	Please see description above.	Follow-up (week 8)
Secondary	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)
Secondary	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)