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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Four Week Self-Compassion Course
Sponsored by
Canterbury Christ Church University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Compassion Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waitlist Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).
Please see description above.
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.
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.
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to 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)
Please see description above.
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).
Please see description above.

Full Information

First Posted
February 18, 2023
Last Updated
May 1, 2023
Sponsor
Canterbury Christ Church University
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1. Study Identification

Unique Protocol Identification Number
NCT05749029
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canterbury Christ Church University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes
Keywords
Compassion Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Four Week Self-Compassion Course
Other Intervention Name(s)
Online Self-Compassion Course
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
Description
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.
Time Frame
Post-intervention (week 4)
Secondary Outcome Measure Information:
Title
Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to post-intervention (week 4).
Description
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.
Time Frame
Post-intervention (week 4)
Title
Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to post-intervention (week 4).
Description
The FSCRS is a 22-item scale with statements measuring inadequate self, hated self and reassured self. Scores will range from 0 to 88.
Time Frame
Post-intervention (week 4)
Title
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).
Description
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.
Time Frame
Post-intervention (week 4)
Title
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).
Description
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.
Time Frame
Post-intervention (week 4)
Title
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).
Description
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.
Time Frame
Post-intervention (week 4)
Title
Change in HbA1c from baseline (week 0) to follow-up (week 8).
Description
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.
Time Frame
Follow-up (week 8)
Title
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).
Description
Please see description above.
Time Frame
Follow-up (week 8)
Title
Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to follow-up (week 8).
Description
Please see description above.
Time Frame
Follow-up (week 8)
Title
Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to follow-up (week 8).
Description
Please see description above.
Time Frame
Follow-up (week 8)
Title
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).
Description
Please see description above.
Time Frame
Follow-up (week 8)
Title
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)
Description
Please see description above.
Time Frame
Follow-up (week 8)
Title
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).
Description
Please see description above.
Time Frame
Follow-up (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hetashi Bawa, BSc, MSc
Phone
01227 927070
Email
hb593@canterbury.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Hebben-Wadey, DClinPsy
Phone
01227 927070
Email
alan.hebben-wadey@canterbury.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Hebben-Wadey, DClinPsy
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hetashi Bawa, BSc, MSc
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road
City
Tunbridge Wells
ZIP/Postal Code
TN1 2YG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hetashi Bawa
Phone
01227 927070
Email
hb593@canterbury.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymised data would be made available to researchers on reasonable request after the study findings have been published.

Learn more about this trial

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

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