TaKeTiNa in the Treatment of Depression: a Pilot Study.

NCT ID: NCT05778643

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-02-15

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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TaKeTiNa

Participants receive TaKeTiNa Music therapy

Group Type EXPERIMENTAL

TaKeTiNa music therapy

Intervention Type BEHAVIORAL

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.

Waiting

Participants receive no additional therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia von Zimmermann, MD

Role: STUDY_CHAIR

UK Erlangen-Nurnberg

Locations

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University Hospital of Erlangen - Psychiatric Clinic

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Claudia von Zimmermann, MD

Role: CONTACT

0049 9131 85 33001

Ali Behzad, MD

Role: CONTACT

0049 9131 85 35000

Facility Contacts

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Johannes Kornhuber, MD

Role: primary

+4991318534166

Other Identifiers

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P066

Identifier Type: -

Identifier Source: org_study_id

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