NCT05873491

Brief Summary

The goal of this observational study is to evaluate the feasibility to develop and implement a music therapy intervention among homeless individuals in French-speaking Switzerland. The main questions it aims to answer are:

  • Are the music therapy sessions acceptable?
  • Are the music therapy sessions feasible?
  • Are the chosen effectiveness primary outcomes appropriate for future larger studies (i.e., health-related quality of life and psychological stress)? Participants will take part in six sub-group (of 6 participants) 2-hours music therapy sessions over 6 weeks. The sessions will be conducted by a certified music therapist and will offer sensory workshops of immersive musical listening, digital and acoustic music creation and shared improvised music. The music therapy sessions aim to create a space for sound and relaxation; promote the emergence of creativity and improvements in social skills and self-esteem through the co-construction of a privileged space for musical interaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

May 4, 2023

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Music therapy acceptability

    Acceptability will be measured based on the recruitment level (#included participants/#invited individuals). Specifically, we will monitor the number of participants invited to participate in the study and the acceptability outcome will be computed by dividing the number of participants who were included in the study by the number of participants who were invited to participate in the study.

    week 1

  • Music therapy feasibility

    Feasibility will be measured based on participants' sessions participation level (#attended session/#total sessions). Specifically, we will monitor music therapy sessions attendance at week 1, 2, 3, 4, 5 and 6 for each included participants and the feasibility outcome will be computed by dividing the number of attended sessions by the total number of offered sessions (i.e., 6).

    week 1, week 2, week 3, week 4, week 5, week 6

Secondary Outcomes (2)

  • Appropriateness of psychological distress outcome for future clinical trials

    week 1 and week 6

  • Appropriateness of quality of life outcome for future clinical trials

    week 1 and week 6

Interventions

The music therapy sessions will offer sensory workshops of immersive musical listening, digital and acoustic music creation and shared improvised music.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include homeless adults in French-speaking Switzerland.

You may qualify if:

  • Being ≥18 ;
  • Being fluent in French;
  • Planning to stay in Lausanne the next 6 weeks;
  • Committing to take part in as many as possible of the music therapy sessions;
  • Agreeing to participate in group session;
  • Being homeless according to the categories 1, 2, 3, or 5 of the ethos-light typology (Baptista \& Marilier, 2019):
  • Living rough (i.e., public spaces); In emergency accommodation (i.e., overnight shelters); Living in accommodation for the homeless (i.e., temporary accommodation); Living in non-conventional dwellings due to lack of housing (i.e., mobile homes; non-conventional buildings);

You may not qualify if:

  • Being unable to provide an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Primary Care and Public Health

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (6)

  • Gaddy MA. Implementation of an integrative medicine treatment program at a Veterans Health Administration residential mental health facility. Psychol Serv. 2018 Nov;15(4):503-509. doi: 10.1037/ser0000189. Epub 2017 Oct 12.

    PMID: 29022737BACKGROUND
  • Maddock, A., D. Hevey, and K. Eidenmuller, Mindfulness training as a clinical intervention with homeless adults: A pilot study. International Journal of Mental Health Addiction, 2017. 15: p. 529-544.

    BACKGROUND
  • Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

    PMID: 15085902BACKGROUND
  • Furukawa TA, Kessler RC, Slade T, Andrews G. The performance of the K6 and K10 screening scales for psychological distress in the Australian National Survey of Mental Health and Well-Being. Psychol Med. 2003 Feb;33(2):357-62. doi: 10.1017/s0033291702006700.

    PMID: 12622315BACKGROUND
  • Baptista, I. and E. Marilier, Fighting homelessness and housing exclusion in Europe: A study of national policies, E.S.P.N. (ESPN), Editor. 2019: Brussels: European Commission.

    BACKGROUND
  • Garland EL, Roberts-Lewis A, Tronnier CD, Graves R, Kelley K. Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial. Behav Res Ther. 2016 Feb;77:7-16. doi: 10.1016/j.brat.2015.11.012. Epub 2015 Nov 27.

    PMID: 26701171BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Véronique S Grazioli, PhD

    Center for Primary Care and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 24, 2023

Study Start

May 22, 2023

Primary Completion

July 9, 2023

Study Completion

August 31, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.

Locations