Teaching Adolescents with Type 1 Diabetes Self-compassion

NCT05463874 | Completed

• 1 other identifier: 22/08E
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (5)

• Anxiety as measured by the Generalized Anxiety 7-item scale (GAD-7)

  3 months, 12 months

• Depression as measured by the Patient Health Questionnaire (PHQ-9)

  3 months, 12 months

• Disordered eating as measured by the Diabetes Eating Problem Survey, revised version (DEPS-R)

  3 months, 12 months

• Suicidal ideation as measured by the Patient Health Questionnaire (PHQ-9)

  3 months, 12 months

• Diabetes distress as measured by the Problem Areas in Diabetes - Teen version (PAID-T)

  12 months

Other Outcomes (3)

• Interaction term of time and diabetes distress

  Baseline, 8 weeks, 3 months, 6 months, 12 months

• Hemoglobin A1c

  Baseline, 12 months

• Time in Range

  Baseline, 8 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Mindful Self-Compassion Arm

EXPERIMENTAL

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

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.

Interventions

Mindful Self-Compassion Program 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.

Mindful Self-Compassion Arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Juvenile Diabetes Research Foundation: collaborator
• Brain Canada: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontatrio, K1H8L1, Canada

Location

Related Publications (1)

• 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.

  PMID: 38048480 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marie-Eve Robinson, MD, MSc

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: October 4, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)