NCT05778643

TaKeTiNa in the Treatment of Depression: a Pilot Study.

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	TaKeTiNa music therapy	TaKeTiNa music therapy uses a group to perform music together. Each member of the group is needed for the synchronization of the whole group. The group actively makes Music with hands, feet, and the voice. At the same time, the therapist frequently introduces new elements into the process and challenges the group in this playful manner. Through this, patients consistently report an increase in mindful awareness and an alleviation of many depressive symptoms, although these effects have not been shown in controlled studies yet.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-02-14
• Completion: 2024-02-15
• First posted: 2023-03-21
• Last updated: 2023-03-22

Locations

1 site across 1 country: Germany