{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T13:26:30Z","timestamp":1787750790422,"version":"build-2784847793"},"reference-count":145,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"unspecified","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Open Access Publishing Fund of Leipzig University","award":["Project DEAL"],"award-info":[{"award-number":["Project DEAL"]}]},{"name":"German Federal Ministry for Education and Research","award":["01GY2108"],"award-info":[{"award-number":["01GY2108"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,10,9]]},"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Patients with chronic somatic diseases such as obesity often develop comorbid depressive symptoms. E-mental health interventions are an innovative and effective treatment option within a stepped care approach. Studies have shown that acceptance and adherence are higher when they are tailored to the specific needs of the target group. This study protocol describes a randomised controlled trial (RCT) of an internet-based self-help intervention, Fit4Mood, to improve mental health in the high-risk group of adults with obesity. The objective of the @ktivPLUS research project is to evaluate the effectiveness, acceptability and cost-effectiveness of the intervention in comparison to an online bibliotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Eligible individuals will be randomly allocated to an intervention group (access to an internet-based intervention) or to an active control group (access to an online bibliotherapy). Assessments will be conducted before the start of the intervention (baseline (BL)) and 4\u2009months after BL (follow-up (FU)). The primary outcome is the reduction in depressive symptoms (Beck Depression Inventory-II) in n=190 participants. Secondary outcomes are anxiety, quality of life, activity, self-efficacy, resilience, mental and digital health literacy, stress, sleep quality, weight loss, weight management activities and readiness to lose weight, weight self-stigma, uptake, adherence and satisfaction with the intervention, workability and cost-effectiveness at follow-up. Additionally, sociodemographics, health, comorbidities and disabilities, as well as internet-specific information, will be assessed at BL. Intention-to-treat analysis using generalised linear mixed models will be applied.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      Approval for this study has been granted by the ethics committee of the\n                      <jats:italic>University of Leipzig<\/jats:italic>\n                      (ID: 140\/25-ek). All participants will provide informed consent prior to participation in the study. Results will be disseminated in peer-reviewed journals and presented at national and international conferences. In the case of a successful evaluation, the internet-based self-help intervention Fit4Mood will be provided as freeware, which will be easily accessible and free of charge.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      The current RCT study has been registered at the German Clinical Trials Register (Identifier: DRKS00036178, Registered 24 June 2025;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.drks.de\/search\/de\/trial\/DRKS00036178\">https:\/\/www.drks.de\/search\/de\/trial\/DRKS00036178<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  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