Type 1 Diabetes MellitusNCT07051005
Feasibility of a Tailored Online Self-compassion Intervention
A study testing Feasibility RCT of a tailored online self-compassion intervention in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus (T2DM), run by Canterbury Christ Church University at 2 sites in United Kingdom.
Trial summary
The goal of this clinical trial is to examine the feasibility and acceptability of an online 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Feasibility RCT of a tailored online self-compassion intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older.
- Diagnosed with Type 1 or Type 2 diabetes by a clinician in the NHS more than one year ago.
- Self-managing theircondition.
- Identified by their NHS team as needing support with their mental health due to diabetes-related distress.
Who cannot join
- <18
- Individuals experiencing a current mental health crisis, including severe depression, active suicidal thoughts, or acute psychosis
- Unable to read/speak English
- Gestational diabetes, Wolfram, and other rarer conditions
- Individuals currently experiencing severe substance abuse issues that could interfere with participation in the programme
- Individuals without reliable access to the internet and a compatible device (computer or smartphone).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Betsi Cadwaladr University Health Board (BCUHB)
Bangor, Wales, LL57 2PW
- Not yet recruiting
Barts Health NHS Trust
London, E1 2ES
About this study
Official title: A Feasibility Randomised Controlled Trial of Online Self-compassion Training Tailored for Adults Living With Type 1 and Type 2 Diabetes Mellitus
The goal of this clinical trial is to examine the feasibility and acceptability of an online 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 pilot randomised controlled trial seeks to examine the feasibility and acceptability of online compassion training tailored for adults living with Type 1 and Type 2 diabetes. Participants will be randomised to either the compassion training course or a waitlist control group, in which participants will be offered the intervention at the end of the study. Four self-report measures will be administered online at baseline (weeks 0-1) and post-intervention (weeks 9-10). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (diabetes distress). These indices will be compared to progression criteria which determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.
- Being tested
- Feasibility RCT of a tailored online self-compassion intervention
- Keywords
- Diabetes, Online intervention, Compassion, Feasibility RCT
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility RCT of a tailored online self-compassion interventionBehavioural
This is a four-week online self-compassion course supplied by Balanced Minds. The researches of this study and an Expert by Experience have consulted with the owner of Balanced Minds to tailor this programme to people with diabetes.
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 |
|---|---|---|
| Online Intervention | Experimental | Four Week Online Self-Compassion Course Receives: Behavioral: Feasibility RCT of a tailored online self-compassion intervention |
| 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.
Number of participants recruited
The number of participants recruited over 6-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: <24.
Measured: 6 months following the start of recruitment
Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions
The proportion of participants who completed at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: <25%.
Measured: Weeks 2 to 8
Proportion of study participants who remain in the study
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: <25%.
Measured: Weeks 0 to 10
Compassion training course acceptability
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed.
Measured: Weeks 9 to 10
Completion rate of the outcome measures
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measure completion: Green: ≥60%; Amber 40-59%; Red: <40%.
Measured: Weeks 0 to 10
Estimate of between group effect size of the compassion training course intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9 - 10).
The estimated between group effect size of the compassion training intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9-10) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: effect size in favour of intervention arm and 95% confidence interval for that effect size contains (or is greater than) the minimal clinically important difference (MCID) found in previous research (0.25 or greater). Amber: effect size is in favour of control, but the minimum clinically important difference is included in the 95% confidence interval; Red: effect size is in favour of control, and the minimum clinically important difference is not included in the 95% confidence interval.
Measured: Weeks 9 - 10
Secondary outcomes (3)
Estimate of the between group effect size of compassion training intervention compared to control on change in the Forms of Self-Criticising/ Attacking & Self-Reassuring (FSCRS) Scale from baseline (weeks 0-1) to post-intervention (weeks 9-10).
The FSCRS is a 22-item self-report measure developed to measure self-criticism and the ability to self-reassure. The scale comprises three subscales: Inadequate-Self, which focuses on feelings of personal inadequacy, Hated-Self, measuring the desire to hurt or punish oneself, and Reassured-Self, which is an ability to reassure and support the self.
Measured: Weeks 9-10
Estimate of the between group effect size of compassion training intervention compared to control on change in the External and Internal Shame Scale (EISS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
This is an eight-item scale informed by the evolutionary, biopsychosocial model measuring external and internal dimensions of shame. Research shows that individuals with chronic physical health conditions report higher levels of internal and external shame.
Measured: Weeks 9-10
Estimate of the between group effect size of compassion training intervention compared to control on change in the Compassionate Engagement and Action Scale (CEAS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
The scale has been validated to measure self-compassion through engagement, by assessing engagement with sensitivity, sympathy, non-judgement, empathy, distress tolerance and caring, and self-compassion through action, by balanced reasoning, focusing attention on helpful contexts, actions that alleviate distress and cultivating inner support to alleviate distress. The 13-item sub-scale within the CEAS will be used (compassion to self).
Measured: Weeks 9-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start18 Jun 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, Betsi Cadwaladr University Health Board
- Responsible party
- Sponsor
- Investigators
- Fergal Jones, PhD, Study chair, Canterbury Christ Church UniversityAlan Hebben-Wadey, DClinPsy, Study director, Canterbury Christ Church UniversityJodie Slevin, BSc, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051005
- Sponsor's protocol ID
- ETH2425-0223
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Banks J, Amspoker AB, Vaughan EM, Woodard L, Naik AD. Ascertainment of Minimal Clinically Important Differences in the Diabetes Distress Scale-17: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342950. doi: 10.1001/jamanetworkopen.2023.42950.
PubMed 37966840
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Trial of Online Self-compassion Training Tailored for Adults Living With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07051005
- Acronym / sponsor ID
- ETH2425-0223
- Keywords
- Diabetes, Online intervention, Compassion, Feasibility RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, Betsi Cadwaladr University Health Board
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 2025 (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 clinical trial is to examine the feasibility and acceptability of an online 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 pilot randomised controlled trial seeks to examine the feasibility and acceptability of online compassion training tailored for adults living with Type 1 and Type 2 diabetes. Participants will be randomised to either the compassion training course or a waitlist control group, in which participants will be offered the intervention at the end of the study. Four self-report measures will be administered online at baseline (weeks 0-1) and post-intervention (weeks 9-10). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (diabetes distress). These indices will be compared to progression criteria which determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Intervention | Experimental | Behavioral: Feasibility RCT of a tailored online self-compassion interventionFour Week Online 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 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older.
- Diagnosed with Type 1 or Type 2 diabetes by a clinician in the NHS more than one year ago.
- Self-managing theircondition.
- Identified by their NHS team as needing support with their mental health due to diabetes-related distress.
Key exclusion criteria (6 listed)
- <18
- Individuals experiencing a current mental health crisis, including severe depression, active suicidal thoughts, or acute psychosis
- Unable to read/speak English
- Gestational diabetes, Wolfram, and other rarer conditions
- Individuals currently experiencing severe substance abuse issues that could interfere with participation in the programme
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 |
|---|---|---|
| Feasibility RCT of a tailored online self-compassion interventionThis is a four-week online self-compassion course supplied by Balanced Minds. The researches of this study and an Expert by Experience have consulted with the owner of Balanced Minds to tailor this programme to people with diabetes. 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. | Behavioural | Online Intervention |
Primary outcome
Number of participants recruited
Time frame: 6 months following the start of recruitment
The number of participants recruited over 6-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: <24.
Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions
Time frame: Weeks 2 to 8
The proportion of participants who completed at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: <25%.
Proportion of study participants who remain in the study
Time frame: Weeks 0 to 10
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: <25%.
Compassion training course acceptability
Time frame: Weeks 9 to 10
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed.
Completion rate of the outcome measures
Time frame: Weeks 0 to 10
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measure completion: Green: ≥60%; Amber 40-59%; Red: <40%.
Estimate of between group effect size of the compassion training course intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9 - 10).
Time frame: Weeks 9 - 10
The estimated between group effect size of the compassion training intervention compared to control on the primary outcome measure of change in Diabetes Distress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 9-10) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: effect size in favour of intervention arm and 95% confidence interval for that effect size contains (or is greater than) the minimal clinically important difference (MCID) found in previous research (0.25 or greater). Amber: effect size is in favour of control, but the minimum clinically important difference is included in the 95% confidence interval; Red: effect size is in favour of control, and the minimum clinically important difference is not included in the 95% confidence interval.
3 secondary outcomes
Estimate of the between group effect size of compassion training intervention compared to control on change in the Forms of Self-Criticising/ Attacking & Self-Reassuring (FSCRS) Scale from baseline (weeks 0-1) to post-intervention (weeks 9-10).
Time frame: Weeks 9-10
Estimate of the between group effect size of compassion training intervention compared to control on change in the External and Internal Shame Scale (EISS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
Time frame: Weeks 9-10
Estimate of the between group effect size of compassion training intervention compared to control on change in the Compassionate Engagement and Action Scale (CEAS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
Time frame: Weeks 9-10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 37966840Banks J, Amspoker AB, Vaughan EM, Woodard L, Naik AD. Ascertainment of Minimal Clinically Important Differences in the Diabetes Distress Scale-17: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342950. doi: 10.1001/jamanetworkopen.2023.42950.
- Diabetes Distress - Screening Scale (DDS17)Link provided by the sponsor.
- The Forms of Self-Criticising/ Attacking \& Self-Reassuring Scale (FSCRS)Link provided by the sponsor.
- Compassionate Engagement and Action Scale (CEAS)Link provided by the sponsor.
- External and Internal Shame Scale (EISS)Link provided by the sponsor.
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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.
Fergal Jones, PhD study chair
Canterbury Christ Church University
Alan Hebben-Wadey, DClinPsy study director
Canterbury Christ Church University
Jodie Slevin, BSc principal investigator
Canterbury Christ Church University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility RCT of a tailored online self-compassion intervention in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus (T2DM), run by Canterbury Christ Church University at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodie Slevin, BSc (+4407539333552, js1624@canterbury.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 6 months following the start of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051005, which also lists 1 linked publication.
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 20 Mar 2026.