Teaching Adolescents with Type 1 Diabetes Self-compassion

NCT ID: NCT05463874

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2024-04-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindful Self-Compassion Arm

Participants in this arm will participate in an 8-week virtual mindful self-compassion program.

Group Type: EXPERIMENTAL

Mindful Self-Compassion Program

Intervention Type: BEHAVIORAL

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.

Wait-list Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful Self-Compassion Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between 12-17 years of age
• Diagnosed with type 1 diabetes at least 6 months prior to enrollment
• Able to provide informed consent

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Brain Canada

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Marie-Eve Robinson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Eve Robinson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontatrio, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38048480 (View on PubMed)

Other Identifiers

22/08E

Identifier Type: -

Identifier Source: org_study_id