Type 1 DiabetesTADSNCT05463874
Teaching Adolescents with Type 1 Diabetes Self-compassion
A study testing Mindful Self-Compassion Program in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The purpose of this study is to see if a mindful self-compassion program given virtually can improve emotional distress for youth with type 1 diabetes, compared to routine care as usual. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Mindful Self-Compassion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2022to 1 Apr 2024
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 12-17 years of age
- Diagnosed with type 1 diabetes at least 6 months prior to enrollment
- Able to provide informed consent
Who cannot join
- Unable or unwilling to provide informed consent
- Do not speak English or French with enough fluency to complete all study related tasks
- Presence of an intellectual disability that would preclude participation in the MSC intervention, as assessed by the treating physician
- Lifetime diagnosis of a serious mental illness given by a clinician (e.g., psychotic or bipolar disorders), as these often involve intensive treatments with psychological and/or pharmacologic implications, which may confound our results.
- Presence of acute suicidality at the time of enrollment (if a patient reports suicidality on the baseline questionnaires, a same-day assessment will be conducted to assess for acute suicidality. If present, the patient will receive immediate clinical attention and will no longer be eligible to participate in the study).
- Active participation in another mental health intervention trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teaching Adolescents with Type 1 Diabetes Self-compassion to Reduce Diabetes Distress: a Randomized Controlled Trial
The purpose of this study is to see if a mindful self-compassion program given virtually can improve emotional distress for youth with type 1 diabetes, compared to routine care as usual.
Read the detailed description
Background: Type 1 diabetes (T1D) is a chronic, life-long condition. Youth with T1D must monitor their blood sugar levels, nutrition, physical activity, and other daily activities. They also need insulin multiple times per day.
Diabetes distress can happen when all the worry, frustration, anger, and burnout make it hard for people with diabetes to take care of themselves and keep up with the daily demands of their condition. Most youth with T1D experience diabetes distress and over one third experience severe diabetes distress.
Self-compassion is a practice that involves acting the same way towards yourself as you would with friends and loved ones, and that you are kind and understanding towards yourself. Since self-compassion is a skill that can be taught, we hypothesize that it could be a strategy to improve mental health issues in youth with T1D, like diabetes distress.
Objectives: The aim of our study is to assess the effectiveness of a mindful self-compassion program on improving the diabetes distress experienced by youth aged 12-17 years with T1D. We will compare if diabetes distress 3 months after enrolment in the study is different among youth that received the mindful self-compassion program versus the ones that did not. We will also assess the effect of the program on anxiety, depression, diabetes-related disordered eating, and suicidal ideation. Finally, we will explore the effect of the program on blood sugar control, and if the effects change over time.
Methods: Our study will be a randomized controlled trial of youth aged 12-17 years, with a diagnosis of T1D. Participants will be recruited from the diabetes clinic at the Children's Hospital of Eastern Ontario (CHEO) and randomized to the mindful self-compassion program or a wait-list control group. The mindful self-compassion program will consist of weekly virtual 1.5-hour sessions/workshops for 8 weeks, led by a trained facilitator. It will cover a variety of self-compassion practices, such as dealing with difficult emotions and developing a kind inner voice. The wait-list group will be offered the mindful self-compassion program once the experimental period of the study is over.
Outcomes in both groups will be assessed at the start of the study, 8-weeks, and at 3-, 6-, and 12- months. Participants showing signs of suicidal ideation or severe depression will be assessed clinically by the study doctor and appropriate follow up actions will be taken.
- Conditions
- Type 1 Diabetes
- Being tested
- Mindful Self-Compassion Program
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-Compassion ProgramBehavioural
The intervention consists of 8 sessions, one per week for 8 weeks, that last 1 hour and 30 minutes each. These sessions will cover a variety of mindfulness and self-compassion practices, such as dealing with difficult emotions and developing a kind inner voice.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion Arm | Experimental | Participants in this arm will participate in an 8-week virtual mindful self-compassion program. Receives: Behavioral: Mindful Self-Compassion Program |
| Wait-list Control Arm | No intervention | Participants in this arm will receive usual clinical care and will have the opportunity to participate in the mindful self-compassion program at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress as measured by the Problem Areas in Diabetes - Teen Version (PAID-T)
Diabetes distress as measured by the PAID-T will be compared in those who complete the MSC program to those in the wait-list control group at 3 months. Scores can range from 26-156, with scores of <70, 70-90, and >90 representing none-to-mild, moderate, and severe diabetes distress, respectively.
Measured: 3 months
Secondary outcomes (5)
Anxiety as measured by the Generalized Anxiety 7-item scale (GAD-7)
Anxiety as measured by the GAD-7 will be compared between those who complete the MSC program and those in the wait-list control group at 3 months and at 12 months. The GAD-7 is scored from 0-21, with 0-4, 5-9, 10-14, and 15-21 indicating minimal, mild, moderate, and severe anxiety symptoms respectively.
Measured: 3 months, 12 months
Depression as measured by the Patient Health Questionnaire (PHQ-9)
Depression as measured by the PHQ-9 in those who complete the MSC program compared to those in the wait-list control group will be assessed at 3 months and at 12 months. PHQ-9 scores range from 0-27, and in adolescents, scores of 0-4, 5-10, 11-14, 15-19, and ≥20 indicate absence of depression, mild depression, moderate depression, moderately severe depression, and severe depression respectively.
Measured: 3 months, 12 months
Disordered eating as measured by the Diabetes Eating Problem Survey, revised version (DEPS-R)
Disordered eating as measured by the DEPS-R will be compared in those who complete the MSC program and those in the wait-list control group at 3 months and at 12 months. The DEPS-R is scored 0-80, with higher scores indicating more disordered eating behaviors and a score of ≥20 considered a positive screen for disordered eating behaviours.
Measured: 3 months, 12 months
Suicidal ideation as measured by the Patient Health Questionnaire (PHQ-9)
Suicidal ideation in those who complete the MSC intervention will be compared to those in the wait-list control group at 3 months and at 12 months. Suicidal ideation will be assessed using one question on the PHQ-9, which asks the respondent if they have had thoughts that they would be better off dead, or of hurting themselves in the previous two weeks. This question is scored on a scale of 0 (not at all) to 3 (nearly every day). In line with previous use of the PHQ-9, we will consider any score of >0 to be indicative that suicidal ideation is present.
Measured: 3 months, 12 months
Diabetes distress as measured by the Problem Areas in Diabetes - Teen version (PAID-T)
Diabetes distress as measured by the PAID-T will be compared in those who complete the MSC program to those in the wait-list control group at 12 months. Scores can range from 26-156, with scores of <70, 70-90, and >90 representing none-to-mild, moderate, and severe diabetes distress, respectively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start4 Oct 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2024
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Brain Canada
- Responsible party
- Principal investigator, Marie-Eve Robinson, Children's Hospital of Eastern Ontario
- Investigators
- Marie-Eve Robinson, MD, MSc, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463874
- Sponsor's protocol ID
- 22/08E
- Acronym
- TADS
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be made available upon reasonable request from other researchers.
Publications
Dover S, Ahmet A, Bluth K, Feldman BM, Goldbloom EB, Goldfield GS, Hamilton S, Imran O, Khalif A, Khatchadourian K, Lawrence S, Leonard A, Liu K, Ouyang Y, Peeters C, Shah J, Spector N, Zuijdwijk C, Robinson ME. Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 26;12:e53935. doi: 10.2196/53935.
PubMed 38048480
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Adolescents with Type 1 Diabetes Self-compassion to Reduce Diabetes Distress: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05463874
- Acronym / sponsor ID
- TADS / 22/08E
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Brain Canada
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 19 Jul 2022 (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 purpose of this study is to see if a mindful self-compassion program given virtually can improve emotional distress for youth with type 1 diabetes, compared to routine care as usual.
Detailed description
Background: Type 1 diabetes (T1D) is a chronic, life-long condition. Youth with T1D must monitor their blood sugar levels, nutrition, physical activity, and other daily activities. They also need insulin multiple times per day.
Diabetes distress can happen when all the worry, frustration, anger, and burnout make it hard for people with diabetes to take care of themselves and keep up with the daily demands of their condition. Most youth with T1D experience diabetes distress and over one third experience severe diabetes distress.
Self-compassion is a practice that involves acting the same way towards yourself as you would with friends and loved ones, and that you are kind and understanding towards yourself. Since self-compassion is a skill that can be taught, we hypothesize that it could be a strategy to improve mental health issues in youth with T1D, like diabetes distress.
Objectives: The aim of our study is to assess the effectiveness of a mindful self-compassion program on improving the diabetes distress experienced by youth aged 12-17 years with T1D. We will compare if diabetes distress 3 months after enrolment in the study is different among youth that received the mindful self-compassion program versus the ones that did not. We will also assess the effect of the program on anxiety, depression, diabetes-related disordered eating, and suicidal ideation. Finally, we will explore the effect of the program on blood sugar control, and if the effects change over time.
Methods: Our study will be a randomized controlled trial of youth aged 12-17 years, with a diagnosis of T1D. Participants will be recruited from the diabetes clinic at the Children's Hospital of Eastern Ontario (CHEO) and randomized to the mindful self-compassion program or a wait-list control group. The mindful self-compassion program will consist of weekly virtual 1.5-hour sessions/workshops for 8 weeks, led by a trained facilitator. It will cover a variety of self-compassion practices, such as dealing with difficult emotions and developing a kind inner voice. The wait-list group will be offered the mindful self-compassion program once the experimental period of the study is over.
Outcomes in both groups will be assessed at the start of the study, 8-weeks, and at 3-, 6-, and 12- months. Participants showing signs of suicidal ideation or severe depression will be assessed clinically by the study doctor and appropriate follow up actions will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion Arm | Experimental | Behavioral: Mindful Self-Compassion ProgramParticipants in this arm will participate in an 8-week virtual mindful self-compassion program. |
| Wait-list Control Arm | No intervention | –Participants in this arm will receive usual clinical care and will have the opportunity to participate in the mindful self-compassion program at the end of the study. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 12-17 years of age
- Diagnosed with type 1 diabetes at least 6 months prior to enrollment
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Unable or unwilling to provide informed consent
- Do not speak English or French with enough fluency to complete all study related tasks
- Presence of an intellectual disability that would preclude participation in the MSC intervention, as assessed by the treating physician
- Lifetime diagnosis of a serious mental illness given by a clinician (e.g., psychotic or bipolar disorders), as these often involve intensive treatments with psychological and/or pharmacologic implications, which may confound our results.
- Presence of acute suicidality at the time of enrollment (if a patient reports suicidality on the baseline questionnaires, a same-day assessment will be conducted to assess for acute suicidality. If present, the patient will receive immediate clinical attention and will no longer be eligible to participate in the study).
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 |
|---|---|---|
| Mindful Self-Compassion ProgramThe intervention consists of 8 sessions, one per week for 8 weeks, that last 1 hour and 30 minutes each. These sessions will cover a variety of mindfulness and self-compassion practices, such as dealing with difficult emotions and developing a kind inner voice. | Behavioural | Mindful Self-Compassion Arm |
Primary outcome
Diabetes Distress as measured by the Problem Areas in Diabetes - Teen Version (PAID-T)
Time frame: 3 months
Diabetes distress as measured by the PAID-T will be compared in those who complete the MSC program to those in the wait-list control group at 3 months. Scores can range from 26-156, with scores of <70, 70-90, and >90 representing none-to-mild, moderate, and severe diabetes distress, respectively.
5 secondary outcomes
Anxiety as measured by the Generalized Anxiety 7-item scale (GAD-7)
Time frame: 3 months, 12 months
Depression as measured by the Patient Health Questionnaire (PHQ-9)
Time frame: 3 months, 12 months
Disordered eating as measured by the Diabetes Eating Problem Survey, revised version (DEPS-R)
Time frame: 3 months, 12 months
Suicidal ideation as measured by the Patient Health Questionnaire (PHQ-9)
Time frame: 3 months, 12 months
Diabetes distress as measured by the Problem Areas in Diabetes - Teen version (PAID-T)
Time frame: 12 months
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 18 Feb 2025.
- Derived from this study: PubMed 38048480Dover S, Ahmet A, Bluth K, Feldman BM, Goldbloom EB, Goldfield GS, Hamilton S, Imran O, Khalif A, Khatchadourian K, Lawrence S, Leonard A, Liu K, Ouyang Y, Peeters C, Shah J, Spector N, Zuijdwijk C, Robinson ME. Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 26;12:e53935. doi: 10.2196/53935.
- Individual participant dataSharing planned: No. IPD will be made available upon reasonable request from other researchers.
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
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.
Marie-Eve Robinson, MD, MSc principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion Program in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 18 Feb 2025. 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 Canada. 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?
Diabetes Distress as measured by the Problem Areas in Diabetes - Teen Version (PAID-T) (time frame: 3 months). 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 NCT05463874, 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 18 Feb 2025.