Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial
BackgroundAdolescents 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...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2023-12-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e53935 |
| _version_ | 1827398047561154560 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Saunya Dover |
| collection | DOAJ |
| description |
BackgroundAdolescents 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.
ObjectiveThe 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.
MethodsWe 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).
ResultsStudy 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.
ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874
International Registered Report Identifier (IRRID)DERR1-10.2196/53935 |
| first_indexed | 2024-03-08T19:23:54Z |
| format | Article |
| id | doaj.art-d71856b0bab740d88da4fbc12e97ef16 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-08T19:23:54Z |
| publishDate | 2023-12-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-d71856b0bab740d88da4fbc12e97ef162023-12-26T13:45:33ZengJMIR PublicationsJMIR Research Protocols1929-07482023-12-0112e5393510.2196/53935Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled TrialSaunya Doverhttps://orcid.org/0000-0001-5935-8101Alexandra Ahmethttps://orcid.org/0000-0002-3226-8322Karen Bluthhttps://orcid.org/0000-0001-7535-6405Brian M Feldmanhttps://orcid.org/0000-0002-7813-9665Ellen B Goldbloomhttps://orcid.org/0000-0002-6582-2924Gary S Goldfieldhttps://orcid.org/0000-0001-6216-7824Sarah Hamiltonhttps://orcid.org/0009-0003-7454-6399Omar Imranhttps://orcid.org/0009-0004-2791-5435Adam Khalifhttps://orcid.org/0009-0003-4327-2989Karine Khatchadourianhttps://orcid.org/0000-0001-6330-8772Sarah Lawrencehttps://orcid.org/0000-0002-7103-158XAndrew Leonardhttps://orcid.org/0009-0009-8293-9487Kuan Liuhttps://orcid.org/0000-0002-5017-1276Yongdong Ouyanghttps://orcid.org/0000-0002-8692-2991Corien Peetershttps://orcid.org/0009-0001-1862-0094Jai Shahhttps://orcid.org/0000-0002-7549-6990Noah Spectorhttps://orcid.org/0000-0001-8729-1354Caroline Zuijdwijkhttps://orcid.org/0000-0003-0369-5103Marie-Eve Robinsonhttps://orcid.org/0000-0002-2539-227X BackgroundAdolescents 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. ObjectiveThe 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. MethodsWe 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). ResultsStudy 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874 International Registered Report Identifier (IRRID)DERR1-10.2196/53935https://www.researchprotocols.org/2023/1/e53935 |
| spellingShingle | 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 Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial |
| title_full | Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial |
| title_fullStr | Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial |
| title_short | Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial |
| title_sort | teaching adolescents with type 1 diabetes self compassion tads to reduce diabetes distress protocol for a randomized controlled trial |
| url | https://www.researchprotocols.org/2023/1/e53935 |
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