Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778643
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2023-02-21
Brief Title:
TaKeTiNa in the Treatment of Depression a Pilot Study
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical studys to analyse the impact of TaKeTiNa music therapy in depressed patients
The main questions 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 T1T2 group than in the W1W2 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
The main questions 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 T1T2 group than in the W1W2 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None