TaKeTiNa in the Treatment of Depression: a Pilot Study.

Major Depressive Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778643
• Other study ID #: P066
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: December 2022
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Claudia von Zimmermann, MD
• Phone: 0049 9131 85 33001
• Email: Claudia.von.Zimmermann[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 15, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Major depressive disorder Ability to walk, speak, and clap

Exclusion Criteria:

• psychotic symptoms

• acute suicidality

• prior intolerance to body therapeutic methods

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital of Erlangen - Psychiatric Clinic	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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