People Experiencing Homelessness and Integrative Medical Care: Implementing Music Therapy, Art Therapy and Mindfulness Meditation Sessions in a Low-Threshold Day-in Center in Lausanne for Greater Health Equity (HoPim)

September 24, 2026 updated by: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

The goal of this study is to evaluate the feasibility and acceptability of implementing group sessions of music therapy, art therapy and mindfulness meditation in real-life setting in a specific context (in a low threshold day-center for people experiencing homelessness in Lausanne "L'Espace"). The second aims consists of exploring participants' experience of these implemented approaches and describe participants' trajectories in terms of health-related QoL, psychological distress, perception of pain, self-esteem and relation to others over time.

The sessions will be implemented sequentially in three blocks:

  • Music therapy: 8 biweekly 2 hours sessions over 4 months (group of 8-12 participants);
  • Art therapy: 8 biweekly 2 hours sessions over 4 months (group of 8 12 participants);
  • Mindfulness meditation: two consecutive 8-week program (weekly 2 hours sessions, group of 8-12 participants).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants who provide informed written consent will complete questionnaires at baseline (T0; inclusion), one month (T1), at the end of the sessions' block (T2) and at 8 months (T3). The questionnaire will assess secondary endpoints outlined above. Questionnaires will be hetero-administrated. A T2, semi-structured interviews will be conducted with participants and practitioners to explore perceived benefits, acceptability and implementation experience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Center for Primary Care and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being ≥18;
  • Being fluent in the languages known by the practitioners (English and French for music therapy and art therapy, Franch for mindfulness meditation);
  • Planning to stay in Lausanne for the next 10 months;
  • Agreeing to participate in group sessions;
  • Being homeless according to the categories 1, 2, 3, or 5 of the ETHOS Light typology.

Exclusion Criteria:

  • Being unable to provide an informed consent.
  • For all interventions: having an unstable mental health issue (actively suicidal depression, active PTSD, decompensated bipolar, acute psychotic episode).
  • For the mindfulness meditation blocks only: being in psychological decompensation (including schizophrenia, bipolar disorder, addictive disorders, and suicidal thoughts); suffering from epilepsy, complex trauma or unstable PTSD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music therapy, Art therapy, Mindfulness Meditation

Participants will sequentially receive three interventions: music therapy, art therapy, and mindfulness meditation. The interventions will be implemented in a low-threshold drop-in center for people experiencing homelessness in Switzerland. Feasibility and acceptability of implementing these interventions in a real-life setting will be evaluated.
Behavioral: Music therapy

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

Behavioral: Art therapy

Art therapy sessions will include activities combining painting, modeling, and movement based on an initial theme.

Behavioral: Mindfulness Meditation

Mindfulness meditation sessions will involve foundational practices designed to enhance participants' ability to focus attention on a chosen object, such as the breath, while observing when the mind wanders and gently bringing attention back to the object of focus.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptance rate
Time Frame: Throughout the recruitment period, up to 1 month

The acceptability (acceptance rate) will be assessed in terms of recruitment rate (#people included/#people invited).
Throughout the recruitment period, up to 1 month
Attendance rate
Time Frame: From enrollment through 4 months for music therapy and art therapy; and from enrollment through 2 months for mindfulness meditation

The feasibility of implementing music therapy, art therapy, and mindfulness meditation in a real-life setting will be assessed in terms of attendance at intervention sessions (number of sessions attended/total number of sessions offered).
From enrollment through 4 months for music therapy and art therapy; and from enrollment through 2 months for mindfulness meditation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation

Health related quality of life will be assessed with a subscale of the World Health Organization Quality of Life - Brief Version, Physical Health Domain (WHOQOL-BREF); range 0-100, with higher scores indicating better health-related quality of life (better outcome).

Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
Relatedness to others
Time Frame: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation

Relatedness to others will be assessed with a subscale of the Basic Psychological Need Satisfaction Scale (BPNSS); range 1-7, with higher scores indicating greater psychological need satisfaction (better outcome).

Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
Psychological distress
Time Frame: Baseline, 1 month, and 4 months for music therapy and art therapy; and baseline, T1 (1 month), T2 (2 months) for mindfulness meditation

Psychological distress will be assessed with the Kessler Psychological Distress Scale (K6); range 0-24, with higher scores indicating greater psychological distress (worse outcome).

Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation
Baseline, 1 month, and 4 months for music therapy and art therapy; and baseline, T1 (1 month), T2 (2 months) for mindfulness meditation
Self-esteem
Time Frame: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation

Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES); range 0-30, with higher scores indicating higher self-esteem (better outcome). Questionnaires will be administered at T0 (baseline), T1 (1 month), and T2 (4 months) for music therapy and art therapy, and at T0 (baseline), T1 (1 month), and T2 (2 months) for mindfulness meditation.
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-00812
  • 6071.19 (Other Grant/Funding Number: Leenaards Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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