Homeless People in French-speaking Switzerland and Integrative Medicine: A Pilot Intervention in Music Therapy

Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05873491
Collaborator
(none)
12
1
3.3
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music therapy

Detailed Description

Study procedures:

The research team will recruit homeless service users within low-threshold institutions for homeless people in Lausanne and conduct the informed consent process. Participants agreeing to participate and providing written informed consent will complete a hetero-administrated paper-pencil questionnaire before receiving the first intervention session (T0). Parts of the dimensions assessed with this questionnaires (i.e., outcomes) will be reassessed after receiving the 6 music therapy sessions (T1).

At T0, the questionnaire will measure participants' demographics, health-related quality of life (QoL), psychological stress levels and self-esteem. Questionnaire completion will last between around 30 minutes each, depending on the support needed by the participants.

At T1, participants will complete a second questionnaire (T1). This questionnaire will assess the same dimensions than the ones at T0 except demographics and will also evaluate participants' satisfaction regarding the intervention sessions.

Quantitative assessment will be completed by qualitative evaluation through field observation during the 6 music therapy sessions by the research team. At T1, trained research staff will conduct one-on-one semi-structured interviews with the participants as well as with the music therapist. This qualitative assessment will aim at exploring therapist and participants' experience of the music therapy sessions. The semi-structured interview will last 30-60 minutes.

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Homeless People in French-speaking Switzerland and Integrative Medicine: A Pilot Intervention in Music Therapy
Anticipated Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
Jul 9, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Music therapy acceptability [week 1]

    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.

  2. Music therapy feasibility [week 1, week 2, week 3, week 4, week 5, week 6]

    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).

Secondary Outcome Measures

  1. Appropriateness of psychological distress outcome for future clinical trials [week 1 and week 6]

    In line with similar past pilot research among homeless individuals (Gaddy, 2018; Garland et al., 2016; Maddock et al., 2017), this questionnaire will evaluate psychological distress with the Kessler Psychological Distress Scale (K6) (Furukawa et al., 2003).

  2. Appropriateness of quality of life outcome for future clinical trials [week 1 and week 6]

    Perceived QoL using the World Health Organization Quality of Life-BREF (Skevington et al., 2004).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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);

Exclusion Criteria:
  • Being unable to provide an informed consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Primary Care and Public Health Lausanne Vaud Switzerland 1011

Sponsors and Collaborators

  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Investigators

  • Principal Investigator: Véronique S Grazioli, PhD, Center for Primary Care and Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier:
NCT05873491
Other Study ID Numbers:
  • 2023-00514
First Posted:
May 24, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 26, 2023