Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy
Introduction Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-r...
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e065997.full |
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| author | Marianne Bonnert Maria Lalouni Jennifer Stinson Rikard K Wicksell Laura E Simons Lauren E Harrison Sarah N Webster Amanda R Van Orden Ellison Choate Nicole Jehl Beth D Darnall |
| author_facet | Marianne Bonnert Maria Lalouni Jennifer Stinson Rikard K Wicksell Laura E Simons Lauren E Harrison Sarah N Webster Amanda R Van Orden Ellison Choate Nicole Jehl Beth D Darnall |
| author_sort | Marianne Bonnert |
| collection | DOAJ |
| description | Introduction Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination.Methods and analysis This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage.Ethics and dissemination This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media.Trial registration number NCT05079984. |
| format | Article |
| id | doaj-art-490b00badedb45149e8f8cd055a5c680 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-490b00badedb45149e8f8cd055a5c6802025-08-20T02:14:54ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-065997Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacyMarianne Bonnert0Maria Lalouni1Jennifer Stinson2Rikard K Wicksell3Laura E Simons4Lauren E Harrison5Sarah N Webster6Amanda R Van Orden7Ellison Choate8Nicole Jehl9Beth D Darnall10Region Stockholm, Stockholm, SwedenDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Region Stockholm, SwedenThe Hospital for Sick Children, Toronto, Ontario, CanadaDepartment of Clinical Neuroscience, Karolinska Institute, Stockholm, SwedenDepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USADepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA1 Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California, USAIntroduction Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination.Methods and analysis This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage.Ethics and dissemination This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media.Trial registration number NCT05079984.https://bmjopen.bmj.com/content/12/9/e065997.full |
| spellingShingle | Marianne Bonnert Maria Lalouni Jennifer Stinson Rikard K Wicksell Laura E Simons Lauren E Harrison Sarah N Webster Amanda R Van Orden Ellison Choate Nicole Jehl Beth D Darnall Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy BMJ Open |
| title | Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy |
| title_full | Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy |
| title_fullStr | Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy |
| title_full_unstemmed | Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy |
| title_short | Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy |
| title_sort | agile development of a digital exposure treatment for youth with chronic musculoskeletal pain protocol of a user centred design approach and examination of feasibility and preliminary efficacy |
| url | https://bmjopen.bmj.com/content/12/9/e065997.full |
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