NCT05463874

Teaching Adolescents with Type 1 Diabetes Self-compassion

Teaching Adolescents with Type 1 Diabetes Self-compassion to Reduce Diabetes Distress: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Children's Hospital of Eastern Ontario · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2022-10-04
• Primary completion: 2023-03-01
• Completion: 2024-04-01
• First posted: 2022-07-19
• Last updated: 2025-02-18

Locations

1 site across 1 country: Canada