Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial

Saunya Dover; Alexandra Ahmet; Karen Bluth; Brian M Feldman; Ellen B Goldbloom; Gary S Goldfield; Sarah Hamilton; Omar Imran; Adam Khalif; Karine Khatchadourian; Sarah Lawrence; Andrew Leonard; Kuan Liu; Yongdong Ouyang; Corien Peeters; Jai Shah; Noah Spector; Caroline Zuijdwijk; Marie-Eve Robinson

doi:10.2196/53935

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.

Authors

Saunya Dover¹, Alexandra Ahmet^{1

2

3}, Karen Bluth⁴, Brian M Feldman^{5

6}, Ellen B Goldbloom^{1

2

3}, Gary S Goldfield^{1

3}, Sarah Hamilton¹, Omar Imran¹, Adam Khalif¹, Karine Khatchadourian^{1

2

3}, Sarah Lawrence^{1

2

3}, Andrew Leonard⁷, Kuan Liu⁵, Yongdong Ouyang^{8

9}, Corien Peeters¹⁰, Jai Shah^{11

12}, Noah Spector^{1

3

13}, Caroline Zuijdwijk^{1

2

3}, Marie-Eve Robinson^{1

2

3}

Affiliations

¹ Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.
² Division of Endocrinology & Metabolism, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
³ Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
⁴ Department of Psychiatry, University of North Carolina, Chapel Hill, NC, United States.
⁵ Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
⁶ Division of Rheumatology, Department of Pediatrics, The Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.
⁷ Harvard Extension School, Harvard University, Cambridge, MA, United States.
⁸ Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
⁹ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹⁰ Development & Rehabilitation, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
¹¹ Department of Psychiatry, McGill University, Montreal, QC, Canada.
¹² Douglas Research Centre, Montreal, QC, Canada.
¹³ Eating Disorders Program, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.

PMID: 38048480
PMCID: PMC10777281
DOI: 10.2196/53935

Abstract

Background: Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one's own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught and therefore represents an opportunity for intervention.

Objective: The overall aim of this study is to assess the effectiveness of a web-based mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicidal ideation experienced by youth with T1D (aged between 12 and 17 years) compared with a waitlist control group (standard of care). We will also explore (1) if the effect of the MSC-T intervention changes over time, (2) if the MSC-T intervention has a positive impact on measures of glycemic control, and (3) if the effect of the MSC-T intervention differs based on self-reported gender.

Methods: We will conduct a single-center, parallel-group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the waitlist control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes-Teen (PAID-T) version at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety Disorder 7-item [GAD-7] scale), depression (Patient Health Questionnaire-9 [PHQ-9]), diabetes-related disordered eating (Diabetes Eating Problem Survey-Revised [DEPS-R] version), and suicidal ideation (using 1 question from the PHQ-9).

Results: Study recruitment began in October 2022 and was completed in March 2023, with a total of 141 participants enrolling. Data collection will be ongoing until March 2024. The first results are expected in June 2024.

Conclusions: This study will be the first randomized trial to assess the effectiveness of the web-based MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount.

Trial registration: ClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874.

International registered report identifier (irrid): DERR1-10.2196/53935.

Keywords: anxiety; depression; diabetes distress; disordered eating; mental health; mindful self-compassion; pediatrics; randomized controlled trial; type 1 diabetes.

©Saunya Dover, Alexandra Ahmet, Karen Bluth, Brian M Feldman, Ellen B Goldbloom, Gary S Goldfield, Sarah Hamilton, Omar Imran, Adam Khalif, Karine Khatchadourian, Sarah Lawrence, Andrew Leonard, Kuan Liu, Yongdong Ouyang, Corien Peeters, Jai Shah, Noah Spector, Caroline Zuijdwijk, Marie-Eve Robinson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.12.2023.

Associated data

ClinicalTrials.gov/NCT05463874