TY - JOUR A1 - Heissel, Andreas A1 - Pietrek, Anou F. A1 - Schwefel, Melanie A1 - Abula, Kahar A1 - Wilbertz, Gregor A1 - Heinzel, Stephan A1 - Rapp, Michael Armin T1 - STEP.De study BT - a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services : study protocol JF - BMJ open N2 - Introduction Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment.
Methods and analysis 480 patients (aged 18-65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2: 1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/ 4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020.
Ethics and dissemination The study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universitat Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public. Y1 - 2020 U6 - https://doi.org/10.1136/bmjopen-2019-036287 SN - 2044-6055 VL - 10 IS - 4 PB - BMJ Publishing Group CY - London ER - TY - JOUR A1 - Heinzel, Stephan A1 - Rapp, Michael Armin A1 - Fydrich, Thomas A1 - Ströhle, Andreas A1 - Teran, Christina A1 - Kallies, Gunnar A1 - Schwefel, Melanie A1 - Heissel, Andreas T1 - Neurobiological mechanisms of exercise and psychotherapy in depression BT - the SPeED studyRationale, design, and methodological issues JF - Clinical Trials N2 - Background/Aims: Even though cognitive behavioral therapy has become a relatively effective treatment for major depressive disorder and cognitive behavioral therapy-related changes of dysfunctional neural activations were shown in recent studies, remission rates still remain at an insufficient level. Therefore, the implementation of effective augmentation strategies is needed. In recent meta-analyses, exercise therapy (especially endurance exercise) was reported to be an effective intervention in major depressive disorder. Despite these findings, underlying mechanisms of the antidepressant effect of exercise especially in combination with cognitive behavioral therapy have rarely been studied to date and an investigation of its neural underpinnings is lacking. A better understanding of the psychological and neural mechanisms of exercise and cognitive behavioral therapy would be important for developing optimal treatment strategies in depression. The SPeED study (Sport/Exercise Therapy and Psychotherapyevaluating treatment Effects in Depressive patients) is a randomized controlled trial to investigate underlying physiological, neurobiological, and psychological mechanisms of the augmentation of cognitive behavioral therapy with endurance exercise. It is investigated if a preceding endurance exercise program will enhance the effect of a subsequent cognitive behavioral therapy. Methods: This study will include 105 patients diagnosed with a mild or moderate depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). The participants are randomized into one of three groups: a high-intensive or a low-intensive endurance exercise group or a waiting list control group. After the exercise program/waiting period, all patients receive an outpatient cognitive behavioral therapy treatment according to a standardized therapy manual. At four measurement points, major depressive disorder symptoms (Beck Depression Inventory, Hamilton Rating Scale for Depression), (neuro)biological measures (neural activations during working memory, monetary incentive delay task, and emotion regulation, as well as cortisol levels and brain-derived neurotrophic factor), neuropsychological test performance, and questionnaires (psychological needs, self-efficacy, and quality of life) are assessed. Results: In this article, we report the design of the SPeED study and refer to important methodological issues such as including both high- and low-intensity endurance exercise groups to allow the investigation of dose-response effects and physiological components of the therapy effects. Conclusion: The main aims of this research project are to study effects of endurance exercise and cognitive behavioral therapy on depressive symptoms and to investigate underlying physiological and neurobiological mechanisms of these effects. Results may provide important implications for the development of effective treatment strategies in major depressive disorder, specifically concerning the augmentation of cognitive behavioral therapy by endurance exercise. KW - Major depressive disorder KW - depression KW - psychotherapy KW - cognitive behavioral therapy KW - endurance exercise KW - training KW - functional magnetic resonance imaging KW - brain-derived neurotrophic factor KW - basic psychological needs KW - cortisol Y1 - 2017 U6 - https://doi.org/10.1177/1740774517729161 SN - 1740-7745 SN - 1740-7753 VL - 15 IS - 1 SP - 53 EP - 64 PB - Sage Publ. CY - London ER - TY - JOUR A1 - Kallies, Gunnar A1 - Rapp, Michael Armin A1 - Fydrich, Thomas A1 - Fehm, Lydia A1 - Tschorn, Mira A1 - Teran, Christina A1 - Schwefel, Melanie A1 - Pietrek, Anou F. A1 - Henze, Romy A1 - Hellweg, Rainer A1 - Ströhle, Andreas A1 - Heinzel, Stephan A1 - Heissel, Andreas T1 - Serum brain-derived neurotrophic factor (BDNF) at rest and after acute aerobic exercise in major depressive disorder JF - Psychoneuroendocrinology N2 - Physiological mechanisms of an anti-depressive effect of physical exercise in major depressive disorder (MDD) seem to involve alterations in brain-derived neurotrophic factor (BDNF) level. However, previous studies which investigated this effect in a single bout of exercise, did not control for confounding peripheral factors that contribute to BDNF-alterations. Therefore, the underlying cause of exercise-induced BDNF-changes remains unclear. The current study aims to investigate serum BDNF (sBDNF)-changes due to a single-bout of graded aerobic exercise in a group of 30 outpatients with MDD, suggesting a more precise analysis method by taking plasma volume shift and number of platelets into account. Results show that exercise-induced increases in sBDNF remain significant (p<.001) when adjusting for plasma volume shift and controlling for number of platelets. The interaction of sBDNF change and number of platelets was also significant (p=.001) indicating larger sBDNF-increase in participants with smaller number of platelets. Thus, findings of this study suggest an involvement of peripheral as well as additional possibly brain-derived mechanisms explaining exercise-related BDNF release in MDD. For future studies in the field of exercise-related BDNF research, the importance of controlling for peripheral parameters is emphasized. KW - Brain-derived neurotrophic factor (BDNF) KW - Platelets KW - Major depressive disorder KW - Physical exercise Y1 - 2018 U6 - https://doi.org/10.1016/j.psyneuen.2018.12.015 SN - 0306-4530 VL - 102 SP - 212 EP - 215 PB - Elsevier CY - Oxford ER -