TaKeTiNa in the Treatment of Depression: a Pilot Study.
- Conditions
- Major Depressive Disorder
- Interventions
- Behavioral: TaKeTiNa music therapy
- Registration Number
- NCT05778643
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Major depressive disorder Ability to walk, speak, and clap
- psychotic symptoms
- acute suicidality
- prior intolerance to body therapeutic methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TaKeTiNa TaKeTiNa music therapy Participants receive TaKeTiNa Music therapy
- Primary Outcome Measures
Name Time Method Comparison of depression severity (HAMD 17) four month Comparison of depression severity (HAMD 17) in the intervention group from beginning of Therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
- Secondary Outcome Measures
Name Time Method Differences in Depression severity (BDI II) four month Differences in Depression severity in the Intervention Group compared to the Control Group , Assessment through BDI II Questionaire
Differences in anxiety (BAI) four month Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through BAI Questionaire
Differences in Cortisol levels four month Differences in Cortisol levels in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Resilience four month Differences in RS-25 in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Composition of adaptive cellular immunity four month Differences in Composition of adaptive cellular immunity in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Adverse events four month Differences in Adverse events in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Mindful Attention and Awareness four month Differences in MAAS in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Heart rate variability four month Differences in Heart rate variability in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in serum lipid levels four month Differences in serum lipid levels in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in social anxiety four month Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through social phobia intentory (SPIN), social interaction anxiety scale (SIAS), social phobia scale (SPS)
Differences in enzymes of sphingolipid metabolism four month Differences in enzymes of sphingolipid metabolism in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Differences in Physical activity four month Differences in Physical activity measured by pedometer in the Intervention Group from beginning of therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
Trial Locations
- Locations (1)
University Hospital of Erlangen - Psychiatric Clinic
🇩🇪Erlangen, Bavaria, Germany