TaKeTiNa in the Treatment of Depression: a Pilot Study.
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TaKeTiNa music therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria: Major depressive disorder Ability to walk, speak, and clap Exclusion Criteria: psychotic symptoms acute suicidality prior intolerance to body therapeutic methods
Sites / Locations
- University Hospital of Erlangen - Psychiatric ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TaKeTiNa
Waiting
Arm Description
Participants receive TaKeTiNa Music therapy
Participants receive no additional therapy
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Differences in Depression severity (BDI II)
Differences in Depression severity in the Intervention Group compared to the Control Group , Assessment through BDI II Questionaire
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT05778643
First Posted
February 21, 2023
Last Updated
March 21, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05778643
Brief Title
TaKeTiNa in the Treatment of Depression: a Pilot Study.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 14, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TaKeTiNa
Arm Type
Experimental
Arm Description
Participants receive TaKeTiNa Music therapy
Arm Title
Waiting
Arm Type
No Intervention
Arm Description
Participants receive no additional therapy
Intervention Type
Behavioral
Intervention Name(s)
TaKeTiNa music therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of depression severity (HAMD 17)
Description
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)
Time Frame
four month
Secondary Outcome Measure Information:
Title
Differences in Depression severity (BDI II)
Description
Differences in Depression severity in the Intervention Group compared to the Control Group , Assessment through BDI II Questionaire
Time Frame
four month
Title
Differences in anxiety (BAI)
Description
Differences in anxiety in the Intervention Group compared to the Control Group and in comparison to pre-intervention , Assessment through BAI Questionaire
Time Frame
four month
Title
Differences in social anxiety
Description
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)
Time Frame
four month
Title
Differences in enzymes of sphingolipid metabolism
Description
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)
Time Frame
four month
Title
Differences in Composition of adaptive cellular immunity
Description
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)
Time Frame
four month
Title
Differences in Adverse events
Description
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)
Time Frame
four month
Title
Differences in Mindful Attention and Awareness
Description
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)
Time Frame
four month
Title
Differences in Resilience
Description
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)
Time Frame
four month
Title
Differences in Physical activity
Description
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)
Time Frame
four month
Title
Differences in Heart rate variability
Description
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)
Time Frame
four month
Title
Differences in Cortisol levels
Description
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)
Time Frame
four month
Title
Differences in serum lipid levels
Description
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)
Time Frame
four month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major depressive disorder Ability to walk, speak, and clap
Exclusion Criteria:
psychotic symptoms
acute suicidality
prior intolerance to body therapeutic methods
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia von Zimmermann, MD
Phone
0049 9131 85 33001
Email
Claudia.von.Zimmermann@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Behzad, MD
Phone
0049 9131 85 35000
Email
Ali.Behzad@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia von Zimmermann, MD
Organizational Affiliation
UK Erlangen-Nurnberg
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Erlangen - Psychiatric Clinic
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Kornhuber, MD
Phone
+4991318534166
Email
direktion-psych@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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TaKeTiNa in the Treatment of Depression: a Pilot Study.
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