Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial
Introduction Weight restoration is a primary goal in anorexia nervosa (AN) treatment. Recent studies suggest that addressing physical activity urges in patients with AN is a promising target to facilitate weight restoration. This trial will evaluate the feasibility of a virtual reality (VR)-based in...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e097886.full |
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| author | Nina Timmesfeld Georgios Paslakis Georg Halbeisen |
| author_facet | Nina Timmesfeld Georgios Paslakis Georg Halbeisen |
| author_sort | Nina Timmesfeld |
| collection | DOAJ |
| description | Introduction Weight restoration is a primary goal in anorexia nervosa (AN) treatment. Recent studies suggest that addressing physical activity urges in patients with AN is a promising target to facilitate weight restoration. This trial will evaluate the feasibility of a virtual reality (VR)-based intervention as an add-on treatment to psychotherapy to improve activity urges and, consequently, initial treatment responses on core outcomes as targeted per AN treatment guidelines.Methods and analysis This single-centre feasibility trial adopts the single-blind, two-arm design and outcome measures of an intended full-scale randomised controlled trial (RCT) in order to establish that all necessary trial components work together as intended. It will evaluate feasibility as the primary endpoint and compare changes in ratings of the urge to be active between patients with AN randomly assigned to receiving VR intervention sessions and patients with AN in a control procedure. The feasibility of the full-scale RCT will depend on whether patients (1) will evaluate the experience as acceptable, (2) tolerate VR side effects and (3) will adhere to the intended intervention schedule. We define a set of three-tiered, formal progression criteria and employ a ‘traffic light system’ demarcating go (green), amend (amber) and stop (red) signals for advancing to the full-scale RCT.Ethics and dissemination The study was approved by the ethics committee of the Ruhr University Bochum’s Medical Faculty at Campus East-Westphalia (AZ 2024-1296, 9 December 2024). Patients have to provide written consent before taking part in the study. The findings will be published with open access.Trial registration number DRKS00035681, German Clinical Trials Register. |
| format | Article |
| id | doaj-art-7b72e7ea3f96433bb3b552358e6877ae |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-7b72e7ea3f96433bb3b552358e6877ae2025-02-01T03:30:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-097886Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trialNina Timmesfeld0Georgios Paslakis1Georg Halbeisen2Department of Medical Informatics, Biometry & Epidemiology, Ruhr University Bochum, Bochum, GermanyUniversity Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr University Bochum, Bochum, GermanyUniversity Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr University Bochum, Bochum, GermanyIntroduction Weight restoration is a primary goal in anorexia nervosa (AN) treatment. Recent studies suggest that addressing physical activity urges in patients with AN is a promising target to facilitate weight restoration. This trial will evaluate the feasibility of a virtual reality (VR)-based intervention as an add-on treatment to psychotherapy to improve activity urges and, consequently, initial treatment responses on core outcomes as targeted per AN treatment guidelines.Methods and analysis This single-centre feasibility trial adopts the single-blind, two-arm design and outcome measures of an intended full-scale randomised controlled trial (RCT) in order to establish that all necessary trial components work together as intended. It will evaluate feasibility as the primary endpoint and compare changes in ratings of the urge to be active between patients with AN randomly assigned to receiving VR intervention sessions and patients with AN in a control procedure. The feasibility of the full-scale RCT will depend on whether patients (1) will evaluate the experience as acceptable, (2) tolerate VR side effects and (3) will adhere to the intended intervention schedule. We define a set of three-tiered, formal progression criteria and employ a ‘traffic light system’ demarcating go (green), amend (amber) and stop (red) signals for advancing to the full-scale RCT.Ethics and dissemination The study was approved by the ethics committee of the Ruhr University Bochum’s Medical Faculty at Campus East-Westphalia (AZ 2024-1296, 9 December 2024). Patients have to provide written consent before taking part in the study. The findings will be published with open access.Trial registration number DRKS00035681, German Clinical Trials Register.https://bmjopen.bmj.com/content/15/1/e097886.full |
| spellingShingle | Nina Timmesfeld Georgios Paslakis Georg Halbeisen Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial BMJ Open |
| title | Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial |
| title_full | Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial |
| title_fullStr | Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial |
| title_full_unstemmed | Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial |
| title_short | Reducing the urge to be physically active in patients with anorexia nervosa through virtual reality: protocol for a randomised-controlled feasibility trial |
| title_sort | reducing the urge to be physically active in patients with anorexia nervosa through virtual reality protocol for a randomised controlled feasibility trial |
| url | https://bmjopen.bmj.com/content/15/1/e097886.full |
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