Type 1 DiabetesNCT05749029
An Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).
A study testing Four Week Self-Compassion Course in people with Type 1 Diabetes and Type 2 Diabetes, run by Canterbury Christ Church University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Four Week Self-Compassion Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of Gestational Diabetes or Pre-Diabetes.
- Current severe mental health condition;
- Currently self-harming or suicidal;
- Currently engaging in psychological therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road
Royal Tunbridge Wells, Tunbridge Wells, TN1 2YG
About this study
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)
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.
Read the 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).
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Four Week Self-Compassion Course
- Keywords
- Compassion Intervention
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Week Self-Compassion CourseBehavioural
Also called Online 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Four Week Self-Compassion Course |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (week 4)
Secondary outcomes (12)
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.
Measured: Post-intervention (week 4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up (week 8)
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).
Please see description above.
Measured: 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.
Measured: 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.
Measured: Follow-up (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 May 2023
- Primary completion31 Oct 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hetashi Bawa, Canterbury Christ Church University
- Investigators
- Alan Hebben-Wadey, DClinPsy, Study director, Canterbury Christ Church UniversityHetashi Bawa, BSc, MSc, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749029
- Sponsor's protocol ID
- Hetashi Bawa MRP 2021
- Status last verified
- Oct 2024
- First submitted
- 18 Feb 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data would be made available to researchers on reasonable request after the study findings have been published.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05749029
- Acronym / sponsor ID
- Hetashi Bawa MRP 2021
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Compassion Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Four Week Self-Compassion Course |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Diagnosis of Gestational Diabetes or Pre-Diabetes.
- Current severe mental health condition;
- Currently self-harming or suicidal;
- Currently engaging in psychological therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four Week Self-Compassion CourseAlso: Online Self-Compassion CourseThis 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. | Behavioural | Intervention |
Primary outcome
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).
Time frame: 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.
12 secondary outcomes
Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to post-intervention (week 4).
Time frame: Post-intervention (week 4)
Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to post-intervention (week 4).
Time frame: Post-intervention (week 4)
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).
Time frame: Post-intervention (week 4)
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).
Time frame: Post-intervention (week 4)
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).
Time frame: Post-intervention (week 4)
Change in HbA1c from baseline (week 0) to follow-up (week 8).
Time frame: Follow-up (week 8)
Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).
Time frame: 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).
Time frame: 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).
Time frame: Follow-up (week 8)
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).
Time frame: Follow-up (week 8)
Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)
Time frame: Follow-up (week 8)
Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).
Time frame: Follow-up (week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No. Anonymised data would be made available to researchers on reasonable request after the study findings have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Hebben-Wadey, DClinPsy study director
Canterbury Christ Church University
Hetashi Bawa, BSc, MSc principal investigator
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four Week Self-Compassion Course in people with Type 1 Diabetes and Type 2 Diabetes, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4). (time frame: Post-intervention (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.