TaKeTiNa in the Treatment of Depression: a Pilot Study.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: TaKeTiNa music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major depressive disorder Ability to walk, speak, and clap Exclusion Criteria: psychotic symptoms acute suicidality prior intolerance to body therapeutic methods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TaKeTiNa<br>Participants receive TaKeTiNa Music therapy | Behavioral: TaKeTiNa music therapy<br>* 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.<br>|
| No Intervention: Waiting<br>Participants receive no additional therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of depression severity (HAMD 17) | 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) | four month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Depression severity (BDI II) | Differences in Depression severity in the Intervention Group compared to the Control Group , Assessment through BDI II Questionaire | four month | 
| Differences in anxiety (BAI) | Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through BAI Questionaire | four month | 
| Differences in social anxiety | 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) | four month | 
| Differences in enzymes of sphingolipid metabolism | 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) | four month | 
| Differences in Composition of adaptive cellular immunity | 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) | four month | 
| Differences in Adverse events | 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) | four month | 
| Differences in Mindful Attention and Awareness | 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) | four month | 
| Differences in Resilience | 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) | four month | 
| Differences in Physical activity | 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) | four month | 
| Differences in Heart rate variability | 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) | four month | 
| Differences in Cortisol levels | 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) | four month | 
| Differences in serum lipid levels | 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) | four month |