Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents

NCT04454736 | Unknown

• 1 other identifier: Grebosz-Haring SingingStudy
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase), immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood, social contacts, emotional and social competence, self-esteem, and quality of life) responses in mentally ill and healthy children and adolescents (N=135, age range 10 -18). Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three hour creative workshops every two weeks.

Conditions

Stress

Keywords

Mental health; Youth; Singing; Music; Stress; Cortisol; Alpha Amylase; Immunoglobulin A

Outcome Measures

Primary Outcomes (4)

• Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months

  Biological Stress Marker: Salivary Cortisol

  every two weeks pre- and post singing sessions for six months

• Change Short-Term Immune Function from pre- to post singing session over six months

  Biological Marker: Salivary Immunoglobulin A

  every two weeks pre- and post singing sessions for six months

• Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months

  Biological Stress Marker: Hair Cortisol

  at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months

• Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months

  Salivary Alpha-Amylase

  every two weeks pre- and post singing sessions for six months

Secondary Outcomes (16)

• Psychological Stress

  at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months

• Mood

  every week pre- and post singing sessions for six months

• Emotional Skills

  at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months

• Self-Esteem

  at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months

• Life Quality

  once a month for six months

Study Arms (3)

SBGmentdis

EXPERIMENTAL

Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria

Behavioral: "Amateur" Group Singing

SBGhealthy

EXPERIMENTAL

Healthy children and adolescents from schools in Salzburg, Austria

Behavioral: "Amateur" Group Singing

VIEhealthy

EXPERIMENTAL

Members from the Vienna Boys Choir, Austria

Behavioral: "Professional" Group Singing

Interventions

"Amateur" Group Singing BEHAVIORAL

45-minute singing session led by a professional choirmaster without a therapeutic background once a week

SBGhealthy; SBGmentdis

"Professional" Group Singing BEHAVIORAL

120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.

VIEhealthy

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Written consent to study participation;
• Gender: male, female, different;
• Age: children and adolescents aged ≥ 10 and ≤ 18 years;
• Diagnosis of a psychiatric disorder according to ICD-10;
• Patients are admitted regardless of medication status and are allowed to the medication will continue to be used during the study;
• Musical skills or a certain musical background are not required
• Written consent to study participation;
• Gender: male, female, different;
• Age: children and adolescents aged ≥ 10 and ≤ 18 years;
• Musical skills or a certain musical background are not required

You may not qualify if:

• Age: children and adolescents aged \<10 years and \> 18 years;
• Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize;
• Patients with acute externalizing behavior or self-harm/suicidality;
• Existing alcohol addiction or abuse of illegal drugs;
• Age: children and adolescents aged \<10 years and \> 18 years
• Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize

Sponsors & Collaborators

• University of Salzburg: lead
• Universität Mozartuem Salzburg: collaborator
• Salzburger Landeskliniken: collaborator
• Paracelsus Medical University: collaborator
• University of Vienna: collaborator

Study Sites (3)

Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie

Salzburg, 5020, Austria

RECRUITING

University Mozarteum Salzburg/University of Salzburg

Salzburg, 5020, Austria

RECRUITING

University of Vienna

Vienna, 1010, Austria

RECRUITING

Related Publications (4)

• Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.

  PMID: 30582039 BACKGROUND

• Grebosz-Haring, K., Thun-Hohenstein, L. (2020). Singing for Health and Wellbeing in Children and Adolescents with Mental Disorders. In R. Heydon, D. Fancourt, A. Cohen (Eds.), The Routledge Companion to Interdisciplinary Studies in Singing: Vol 3 Wellbeing. London: Routledge.

  BACKGROUND

• Linnemann, A., Schnersch, A., Nater, U. M. (2017). Testing the beneficial effects of singing in a choir on mood and stress in a longitudinal study: The role of social contacts. Musicae Scientiae, 21(2), 195-212.

  BACKGROUND

• Ali N, Nater UM. Salivary Alpha-Amylase as a Biomarker of Stress in Behavioral Medicine. Int J Behav Med. 2020 Jun;27(3):337-342. doi: 10.1007/s12529-019-09843-x.

  PMID: 31900867 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Katarzyna Grebosz-Haring, Dr.

  University Mozarteum Salzburg, University of Salzburg

  PRINCIPAL INVESTIGATOR

• Leonhard Thun-Hohenstein, Prof. Dr.

  Salzburger Landeskliniken Betriebsges.m.b.H.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Grebosz-Haring, Dr.

CONTACT

+43 - 662 - 8044 - 2370; katarzyna.grebosz-haring@sbg.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: July 1, 2020
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: July 2020-until the end of the study

Locations

AU (3)