Exercise enhances: study protocol of a randomized controlled trial on aerobic exercise as depression treatment augmentat
- PDF / 1,043,702 Bytes
- 11 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 206 Views
STUDY PROTOCOL
Open Access
Exercise enhances: study protocol of a randomized controlled trial on aerobic exercise as depression treatment augmentation Michèle Schmitter1,2* , Jan Spijker1,2, Filip Smit3,4, Indira Tendolkar5, Anne-Marie Derksen6, Peter Oostelbos7, Ben F. M. Wijnen3,8, Tessa J. van Doesum3, Jasper A. J. Smits9 and Janna N. Vrijsen1,5
Abstract Background: Major depressive disorder (MDD) is a considerable public health concern. In spite of evidence-based treatments for MDD, many patients do not improve and relapse is common. Therefore, improving treatment outcomes is much needed and adjunct exercise treatment may have great potential. Exercise was shown to be effective as monotherapy for depression and as augmentation strategy, with evidence for increasing neuroplasticity. Data on the cost-effectiveness and the long-term effects of adjunct exercise treatment are missing. Similarly, the cognitive pathways toward remission are not well understood. Methods: The present study is designed as a multicenter randomized superiority trial in two parallel groups with follow-up assessments up to 15 months. Currently depressed outpatients (N = 120) are randomized to guideline concordant Standard Care (gcSC) alone or gcSC with adjunct exercise treatment for 12 weeks. Randomization is stratified by gender and setting, using a four, six, and eight block design. Exercise treatment is offered in accordance with the NICE guidelines and empirical evidence, consisting of one supervised and two at-home exercise sessions per week at moderate intensity. We expect that gcSC with adjunct exercise treatment is more (cost-)effective in decreasing depressive symptoms compared to gcSC alone. Moreover, we will investigate the effect of adjunct exercise treatment on other health-related outcomes (i.e. functioning, fitness, physical activity, health-related quality of life, and motivation and energy). In addition, the mechanisms of change will be studied by exploring any change in rumination, self-esteem, and memory bias as possible mediators between exercise treatment and depression outcomes. (Continued on next page)
* Correspondence: [email protected] 1 Depression Expertise Centre, Pro Persona Mental Health Care, Nijmegen, The Netherlands 2 Behavioural Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your int
Data Loading...
