TaKeTiNa in the Treatment of Depression: a Pilot Study.

NCT05778643 | Unknown

• 1 other identifier: P066
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Differences in Depression severity (BDI II)

  four month

• Differences in anxiety (BAI)

  four month

• Differences in social anxiety

  four month

• Differences in enzymes of sphingolipid metabolism

  four month

• Differences in Composition of adaptive cellular immunity

  four month

Study Arms (2)

TaKeTiNa

EXPERIMENTAL

Participants receive TaKeTiNa Music therapy

Behavioral: TaKeTiNa music therapy

Waiting

NO INTERVENTION

Participants receive no additional therapy

Interventions

TaKeTiNa music therapy 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.

TaKeTiNa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depressive disorder Ability to walk, speak, and clap

You may not qualify if:

• psychotic symptoms
• acute suicidality
• prior intolerance to body therapeutic methods

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital of Erlangen - Psychiatric Clinic

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Claudia von Zimmermann, MD

  UK Erlangen-Nurnberg

  STUDY CHAIR

Central Study Contacts

Claudia von Zimmermann, MD

CONTACT

0049 9131 85 33001; Claudia.von.Zimmermann@uk-erlangen.de

Ali Behzad, MD

CONTACT

0049 9131 85 35000; Ali.Behzad@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 21, 2023
• Study Start: March 1, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 15, 2024
• Last Updated: March 22, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)