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ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes
INTRODUCTION: Living with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of th...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9478835/ https://www.ncbi.nlm.nih.gov/pubmed/36109030 http://dx.doi.org/10.1136/bmjopen-2021-059336 |
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author | Bendig, Eileen Schmitt, Andreas Wittenberg, Amelie Kulzer, Bernhard Hermanns, Norbert Moshagen, Morten Baumeister, Harald |
author_facet | Bendig, Eileen Schmitt, Andreas Wittenberg, Amelie Kulzer, Bernhard Hermanns, Norbert Moshagen, Morten Baumeister, Harald |
author_sort | Bendig, Eileen |
collection | PubMed |
description | INTRODUCTION: Living with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) ‘ACTonDiabetes’ in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care. METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2–4 weeks after hospital discharge and takes about 7–10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated. ETHICS AND DISSEMINATION: This clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00016738. |
format | Online Article Text |
id | pubmed-9478835 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-94788352022-09-17 ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes Bendig, Eileen Schmitt, Andreas Wittenberg, Amelie Kulzer, Bernhard Hermanns, Norbert Moshagen, Morten Baumeister, Harald BMJ Open Mental Health INTRODUCTION: Living with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) ‘ACTonDiabetes’ in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care. METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2–4 weeks after hospital discharge and takes about 7–10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated. ETHICS AND DISSEMINATION: This clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00016738. BMJ Publishing Group 2022-09-14 /pmc/articles/PMC9478835/ /pubmed/36109030 http://dx.doi.org/10.1136/bmjopen-2021-059336 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Mental Health Bendig, Eileen Schmitt, Andreas Wittenberg, Amelie Kulzer, Bernhard Hermanns, Norbert Moshagen, Morten Baumeister, Harald ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title | ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title_full | ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title_fullStr | ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title_full_unstemmed | ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title_short | ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
title_sort | actondiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes |
topic | Mental Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9478835/ https://www.ncbi.nlm.nih.gov/pubmed/36109030 http://dx.doi.org/10.1136/bmjopen-2021-059336 |
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