A randomized single-blinded prospective study to evaluate the efficacy of an individualized supervised 8-week exercise program in subjects with moderate to severe depressive episodes compared to treatment-as-usual
The purpose of this study is to assess the efficacy of a supervised and indvidualized 8-week exercise program compared to treatment-as-usual in subjects with a moderate or severe depressive episode in the context of unipolar depression or bipolar affective disorders. Numerous previous studies suggest that exercise may help to improve the symptoms of depression. Moreover, exercise was shown to enhance neuroplasticity in adults whereas depression results in decreased neuroplasticity. Here, we aim at elucidating whether a newly developed supervised, Internet-based, individualized exercise program of the Institute of Sports Science and the Department of Psychiatry and Psychotherapy at the University Mainz is more effective in reducing depressive symptoms than treatment-as-usual. Furthermore, this study will clarify if severely depressed subjects are able to adhere to an internet-based exercise therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.
Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
Mainz, Rhineland-Palatinate, Germany
Department of Sports Medicine, Johannes Gutenberg University, Mainz
Mainz, Rhineland-Palatinate, Germany
Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16)
Change of Score on the QIDS C-16 after 8 weeks compared to baseline.
Time frame: 8 weeks
Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - self-report-16 (QIDS SR-16)
Change of Score on the QIDS SR-16 after 8 weeks compared to baseline.
Time frame: 8 weeks
Adherence of internet-based concept
Adherence of internet-based concept using an own questionnaire. Participants respond at the end of every week how they managed their individualized exercise schedule in terms of number of realised training sessions, average heart rate and subjective perceived exertion.
Time frame: 8 weeks
Placebo effect of exercise (QIDS-SR16)
Change of Score on the QIDS-SR16 after one week of training to determine placebo effect of exercise.
Time frame: 8-10 days
Placebo effect of exercise (QIDS-C16)
Change of Score on the QIDS-C16 after one week of training to determine placebo effect of exercise.
Time frame: 8-10 days
Peak oxygen uptake (VO2peak)
Change of VO2peak after 8 weeks compared to baseline. Participants will be subjected to a step-wise treadmill test at baseline and after 8 weeks.
Time frame: 8 weeks
Lactate threshold
Change of lactate threshold using the baseline +1.5 mmol model after 8 weeks compared to baseline.
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Time frame: 8 weeks
Short form 36 (SF36) health survey questionnaire
Change of score on the SF-36 after 8 weeks compared to baseline.
Time frame: 8 weeks
General self efficacy questionnaire (GSE)
Change of score on the GSE after 8 weeks compared to baseline.
Time frame: 8 weeks
Global Clinical Issues (GCI)
Change of score on GCI after 8 weeks compared to baseline.
Time frame: 8 weeks
Circulating, cell-free DNA (cfDNA)
Change of cfDNA concentrations after 8 weeks compared to baseline.
Time frame: 8 weeks