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Immunological Mechanisms in the Treatment of Depression and Their Significance in TaKeTiNa Music Therapy as a New Psychotherapeutic Method. A Waitlist-controlled Randomized Group Pilot Study.
The goal of this clinical study's to analyse the impact of TaKeTiNa music therapy in depressed patients. The main question\[s\] it aims to answer are: . Can TaKeTiNa result in a significant pre-to-post intervention decline of depression severity 2. Can TaKeTiNa result in a significantly lower post-intervention depression severity in the T1/T2 group than in the W1/W2 group. Participants will * be randomly assigned to the two groups, intervention vs. waitlist * receive either an eight week TaKeTiNa music therapy or waitlist * be analysed using questionaires, blood taking, cortisol saliva analysis, measured heart rate variability Researchers will compare a waitlist to see if TakeTiNa is superior to waitlist
One third of the depressed patients do not respond adequately to conventional treatment. This seems to be associated with increased production of proinflammatory cytokines such as TNF-a and IL-1, as well as dysregulation of cortisol levels. This project aims to investigate Investigate the effectiveness of TaKeTiNa music therapy in the treatment of patients with clinical diagnosis of moderate to severe depression Investigate the physiological and pathophysiological effects of TaKeTiNa using novel blood based biomarkers of depression, especially LDL cholesterol as well as on immune system function in order to establish immune system based biomarkers for better diagnosis and therapy monitoring of major depressive disorder.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University Hospital of Erlangen - Psychiatric Clinic
Erlangen, Bavaria, Germany
Start Date
March 1, 2023
Primary Completion Date
February 14, 2024
Completion Date
February 15, 2024
Last Updated
March 22, 2023
120
ESTIMATED participants
TaKeTiNa music therapy
BEHAVIORAL
Lead Sponsor
University of Erlangen-Nürnberg Medical School
NCT07115329
NCT06793397
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07025720