{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T01:45:03Z","timestamp":1785548703995,"version":"3.56.0"},"reference-count":31,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Chronic pain affects approximately 12 million individuals in Germany and significantly impairs quality of life. Although multimodal treatment approaches\u2014combining physical, psychological, and behavioral strategies\u2014are considered the gold standard, access to specialized multidisciplinary pain treatment, including physiotherapy and psychological interventions, is often hampered by long waiting times, which highlights the need for scalable, low-threshold treatment options. Digital health interventions, particularly those grounded in established therapeutic models, offer a promising solution to bridge this treatment gap. The German Digital Health Care Act has opened pathways for reimbursable digital applications, such as CHRONIC, which is grounded in acceptance and commitment therapy as a third-wave cognitive behavioral therapy framework and integrates selected cognitive behavioral techniques, mindfulness-based strategies, and physiotherapy into a structured web-based program.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study protocol outlines a randomized controlled trial (RCT) aimed at evaluating the effectiveness of CHRONIC, a 12-week web-based, multimodal self-help program for individuals with chronic pain, with a focus on reducing pain intensity, reducing pain-related interference, and improving quality of life.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This is a monocentric, 3-arm RCT with assessments up to 6 months after baseline. A total of 200 participants with chronic nonmalignant pain will be randomized into one of three groups: (1) intervention with individualized psychological feedback, (2) intervention with standardized computer-generated feedback, and (3) treatment-as-usual waitlist control. Weekly modules in the intervention arms include psychotherapeutic video sessions, interactive acceptance and commitment therapy\u2013based and cognitive behavioral therapy\u2013based exercises, mindfulness practices, and physiotherapeutic training. Outcomes will be assessed via validated self-report instruments: West Haven-Yale Multidimensional Pain Inventory for pain intensity and interference, Assessment of Quality of Life\u20148 Dimensions for quality of life, German version of Chronic Pain Acceptance Questionnaire for pain acceptance, Patient Health Questionnaire-9, German version for depression, and Generalized Anxiety Disorder 7-item Scale for anxiety. Data will be analyzed using mixed models for repeated measures based on the matched ~6-month assessment. Missing data will be addressed using multiple imputation.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Recruitment started in January 2026 and is projected to end in July 2026. As of January 22, 2026, 18 participants had been enrolled. Primary end point data collection is expected to be completed in January 2027, with primary analyses and dissemination planned for 2027.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This study protocol describes an RCT designed to evaluate the clinical utility of CHRONIC as a scalable, low-threshold intervention for chronic pain. CHRONIC aims to address the multifactorial nature of chronic pain by integrating psychotherapeutic, physiotherapeutic, and mindfulness-based strategies into a single digital program. Future studies will be required to determine how this multimodal format compares to unimodal interventions. The findings aim to inform future digital health developments and contribute to the implementation of biopsychosocial care models in routine practice.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/84437","type":"journal-article","created":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T17:20:06Z","timestamp":1775236806000},"page":"e84437-e84437","source":"Crossref","is-referenced-by-count":1,"title":["Development of a Digital Multimodal Pain Intervention (CHRONIC): Protocol for a Randomized Controlled Trial Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7274-0611","authenticated-orcid":false,"given":"Gentian","family":"Bunjaku","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6491-5056","authenticated-orcid":false,"given":"Lena","family":"Fellbaum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0631-4890","authenticated-orcid":false,"given":"Aaron","family":"Laufh\u00fctte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5069-7278","authenticated-orcid":false,"given":"Tanja","family":"Zimmermann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,5,26]]},"reference":[{"key":"R1","unstructured":"Deutsche Schmerzgesellschaft e.V.. Herausforderung Schmerz [Web page in German]. URL: https:\/\/www.schmerzgesellschaft.de\/patienteninformationen\/herausforderung-schmerz [Accessed 02-09-2025]"},{"issue":"4","key":"R2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.3204","article-title":"Mindfulness vs cognitive behavioral therapy for chronic low back pain treated with opioids: a randomized clinical trial","volume":"8","author":"Zgierska","journal-title":"JAMA Netw Open"},{"issue":"1","key":"R3","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-021-06114-y","article-title":"The burden of waiting to access pain clinic services: perceptions and experiences of patients with rheumatic conditions","volume":"21","author":"Deslauriers","journal-title":"BMC Health Serv Res"},{"issue":"41","key":"R4","doi-asserted-by":"publisher","first-page":"681","DOI":"10.3238\/arztebl.2017.0681","article-title":"An internet-based intervention for chronic pain","volume":"114","author":"Lin","journal-title":"Dtsch Arztebl Int"},{"issue":"1","key":"R5","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1007\/s10865-014-9579-0","article-title":"Internet-based guided self-help intervention for chronic pain based on acceptance and commitment therapy: a randomized controlled trial","volume":"38","author":"Trompetter","journal-title":"J Behav Med"},{"issue":"12","key":"R6","doi-asserted-by":"publisher","first-page":"1491","DOI":"10.1016\/j.jpain.2018.07.005","article-title":"The pain course: 12- and 24-month outcomes from a randomized controlled trial of an internet-delivered pain management program provided with different levels of clinician support","volume":"19","author":"Dear","journal-title":"J Pain"},{"issue":"2","key":"R7","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1037\/a0035514","article-title":"Interdisciplinary chronic pain management: past, present, and future","volume":"69","author":"Gatchel","journal-title":"Am Psychol"},{"issue":"9","key":"R8","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD000963.pub3","article-title":"Multidisciplinary biopsychosocial rehabilitation for chronic low back pain [Article in Spanish]","volume":"2014","author":"Kamper","journal-title":"Cochrane Database Syst Rev"},{"issue":"4","key":"R9","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.9667","article-title":"Effects of a 12-week digital care program for chronic knee pain on pain, mobility, and surgery risk: randomized controlled trial","volume":"20","author":"Mecklenburg","journal-title":"J Med Internet Res"},{"key":"R10","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-019-0109-x","article-title":"App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial","volume":"2","author":"Toelle","journal-title":"NPJ Digit Med"},{"key":"R11","unstructured":"Hayes SC Strosahl KD Wilson KG . Acceptance and Commitment Therapy: An Experiential Approach to Behavior Change. Guilford Publications; 1999. ISBN: 9781572304819"},{"key":"R12","unstructured":"Segal ZV Williams JMG Teasdale JD . Mindfulness-Based Cognitive Therapy for Depression. 2nd ed. Guilford Press; 2013. URL: https:\/\/psycnet.apa.org\/record\/2012-17302-000 [Accessed 05-05-2026]"},{"issue":"1","key":"R13","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1007\/s00296-016-3481-8","article-title":"An overview of treatment approaches for chronic pain management","volume":"37","author":"Hylands-White","journal-title":"Rheumatol Int"},{"key":"R14","doi-asserted-by":"crossref","unstructured":"Skelly AC Chou R Dettori JR et al. Noninvasive nonpharmacological treatment for chronic pain: a systematic review update (comparative effectiveness review no227). Agency for Healthcare Research and Quality; 2020. URL: https:\/\/effectivehealthcare.ahrq.gov\/sites\/default\/files\/related_files\/noninvasive-nonpharm-pain-update.pdf [Accessed 05-05-2026]","DOI":"10.23970\/AHRQEPCCER227"},{"key":"R15","unstructured":"Terminology. International Association for the Study of Pain (IASP). URL: https:\/\/www.iasp-pain.org\/resources\/terminology [Accessed 02-09-2025]"},{"issue":"2","key":"R16","doi-asserted-by":"publisher","first-page":"81","DOI":"10.1016\/j.pneurobio.2008.09.018","article-title":"Towards a theory of chronic pain","volume":"87","author":"Apkarian","journal-title":"Prog Neurobiol"},{"issue":"7","key":"R17","doi-asserted-by":"publisher","first-page":"1995","DOI":"10.1097\/j.pain.0000000000002196","article-title":"Comparing the ICD-11 chronic pain classification with ICD-10: how can the new coding system make chronic pain visible? A study in a tertiary care pain clinic setting","volume":"162","author":"Zinboonyahgoon","journal-title":"Pain"},{"issue":"6","key":"R18","doi-asserted-by":"publisher","first-page":"1003","DOI":"10.1097\/j.pain.0000000000000160","article-title":"A classification of chronic pain for ICD-11","volume":"156","author":"Treede","journal-title":"Pain"},{"issue":"2","key":"R19","doi-asserted-by":"publisher","first-page":"244","DOI":"10.1016\/S0034-7094(12)70122-8","article-title":"Topical analgesics [Article in Portuguese]","volume":"62","author":"Flores","journal-title":"Braz J Anesthesiol"},{"issue":"11","key":"R20","doi-asserted-by":"publisher","DOI":"10.3390\/jcm9113557","article-title":"Mobile application-based interventions for chronic pain patients: a systematic review and meta-analysis of effectiveness","volume":"9","author":"Pfeifer","journal-title":"J Clin Med"},{"issue":"4","key":"R21","doi-asserted-by":"publisher","DOI":"10.3389\/fdgth.2022.850601","article-title":"A systematic review and meta-analysis of digital application use in clinical research in pain medicine","volume":"4","author":"Shetty","journal-title":"Front Digit Health"},{"key":"R22","unstructured":"DiGA-verzeichnis [Web page in German]. Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte. URL: https:\/\/diga.bfarm.de\/de [Accessed 02-09-2025]"},{"issue":"2","key":"R23","doi-asserted-by":"publisher","first-page":"82","DOI":"10.1007\/BF02527839","article-title":"Zur Anwendbarkeit des West Haven-Yale Multidimensional Pain Inventory im deutschen Sprachraum [Article in German]","volume":"4","author":"Flor","journal-title":"Schmerz"},{"issue":"12","key":"R24","doi-asserted-by":"publisher","first-page":"3209","DOI":"10.1007\/s11136-016-1337-z","article-title":"Deriving population norms for the AQoL-6D and AQoL-8D multi-attribute utility instruments from web-based data","volume":"25","author":"Maxwell","journal-title":"Qual Life Res"},{"key":"R25","unstructured":"Nilges P K\u00f6ster B Schmidt CO . CPAQ-D - Chronic Pain Acceptance Questionnaire - Deutsche Fassung [Article in German]. Leibniz Institute for Psychology Information (ZPID); 2011. [doi: 10.23668\/psycharchives.379]"},{"issue":"3","key":"R26","doi-asserted-by":"publisher","first-page":"266","DOI":"10.1097\/MLR.0b013e318160d093","article-title":"Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population","volume":"46","author":"L\u00f6we","journal-title":"Med Care"},{"issue":"2","key":"R27","doi-asserted-by":"publisher","first-page":"90","DOI":"10.3233\/ZMP-2003-12_2_08","article-title":"PHQ-D. Gesundheitsfragebogen f\u00fcr Patienten: 2. Auflage, Pfizer GmbH, Karlsruhe, 2002, kostenlos [Article in German]","volume":"12","author":"L\u00f6we","journal-title":"Z Med Psychol"},{"issue":"12","key":"R28","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.8578","article-title":"Clarifying the concept of adherence to eHealth technology: systematic review on when usage becomes adherence","volume":"19","author":"Sieverink","journal-title":"J Med Internet Res"},{"issue":"1","key":"R29","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0442-1","article-title":"When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts","volume":"17","author":"Jakobsen","journal-title":"BMC Med Res Methodol"},{"issue":"11","key":"R30","doi-asserted-by":"publisher","first-page":"7332","DOI":"10.1111\/jan.16716","article-title":"Recent advances in non-invasive digital nursing technologies for chronic pain assessment and management: an integrative review","volume":"81","author":"Lee","journal-title":"J Adv Nurs"},{"key":"R31","unstructured":"Digital health psychosocial interventions for chronic pain. International Association for the Study of Pain (IASP). 2022. URL: https:\/\/www.iasp-pain.org\/resources\/fact-sheets\/digital-health-psychosocial-interventions-for-chronic-pain [Accessed 02-09-2025]"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e84437","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T22:26:01Z","timestamp":1785536761000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e84437"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,26]]},"references-count":31,"URL":"https:\/\/doi.org\/10.2196\/84437","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,26]]},"article-number":"v15i4e84437"}}