Clinical trial NCT05463874: Teaching Adolescents with Type 1 Diabetes Self-compassion
Official title: Teaching Adolescents with Type 1 Diabetes Self-compassion to Reduce Diabetes Distress: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Brain Canada
First posted: 2022-07-19
Enrollment: 141
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Diabetes Distress as measured by the Problem Areas in Diabetes - Teen Version (PAID-T)
timeFrame: 3 months
Secondary outcomes:
measure: Anxiety as measured by the Generalized Anxiety 7-item scale (GAD-7)
timeFrame: 3 months, 12 months
measure: Depression as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months, 12 months
measure: Disordered eating as measured by the Diabetes Eating Problem Survey, revised version (DEPS-R)
timeFrame: 3 months, 12 months
measure: Suicidal ideation as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months, 12 months
measure: Diabetes distress as measured by the Problem Areas in Diabetes - Teen version (PAID-T)
timeFrame: 12 months
Other outcomes:
measure: Interaction term of time and diabetes distress
timeFrame: Baseline, 8 weeks, 3 months, 6 months, 12 months
measure: Hemoglobin A1c
timeFrame: Baseline, 12 months
measure: Time in Range
timeFrame: Baseline, 8 weeks, 3 months, 6 months, 12 months
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontatrio
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Marie-Eve Robinson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: