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Short-term findings from testing EPIO, a digital self-management program for people living with chronic pain: randomized controlled trial |
Bostrom K, Borosund E, Eide H, Varsi C, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Stavenes Stole H, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L |
Journal of Medical Internet Research 2023;25:e47284 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. OBJECTIVE: This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. METHODS: Patients (n = 266) were randomly assigned to either the EPIO intervention (n = 132) or a care-as-usual control group (n = 134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. RESULTS: The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22 to 78) years and a variety of pain conditions. Analyses (n = 229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (p = 0.84), but significant reductions in the secondary outcomes of depression (mean difference -0.90; p = 0.03) and self-regulatory fatigue (mean difference -2.76; p = 0.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all p > 0.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). CONCLUSIONS: Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.
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