The Concert Therapy Pilot Study for Stress Reduction and Wellbeing (TCT)

February 24, 2026 updated by: BeHnam KhodaRahmi

The Concert Therapy: An Arts-Based Pilot Study on Music, Breathing, and Movement for Stress Reduction and Wellbeing

The Concert Therapy is an arts-based, pilot interventional study designed to explore the effects of live music, guided breathing, and movement on stress reduction and overall wellbeing. Participants take part in one in-person session and one online session integrating musical performance, collective breathing rhythms, and body awareness techniques. The study aims to evaluate pre- and post-intervention changes in perceived stress and emotional wellbeing among adult participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

This pilot study investigates the effects of The Concert Therapy, an arts-based, multi-sensory approach combining music, guided breathing, and mindful movement, on stress reduction and wellbeing.

The intervention includes two formats: one in-person session and one online session delivered via a live, interactive platform. Each session features structured breathing exercises, live musical interaction, and guided movement sequences designed to synchronize rhythm, breath, and body awareness.

A pre-post design is used, with data collected immediately before and after both sessions. Quantitative outcomes include changes in the Perceived Stress Scale (PSS-10), while qualitative data will be gathered through open-ended feedback regarding participants' emotional, physical, and social experiences.

The study aims to generate preliminary evidence on the feasibility and potential benefits of The Concert Therapy as an accessible, arts-based intervention for stress management and wellbeing in both physical and virtual settings.

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 (Actual)

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.
57

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adults aged 18 years and older.

  • Able to understand and provide informed consent.
  • Willing and able to participate in a 60-minute in-person or 33-minute online session of The Concert Therapy.
  • Able to complete brief questionnaires in English before and after the session.

Exclusion Criteria:

  • Self-reported severe mental health conditions requiring medical treatment.
  • Significant hearing impairment that would limit engagement with music.
  • Inability to access the online platform (for online participants).
  • Previous participation in The Concert Therapy study.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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: In-person The Concert Therapy Session
Single-session arts-based intervention delivered in person, combining live music, guided breathing, and gentle movement in a structured three-part format (calming music, breathing & movement, uplifting music).
Behavioral: The Concert Therapy

The Concert Therapy is an arts-based behavioural intervention integrating live music, guided breathing, and gentle movement. Each session follows a three-part structure designed to promote relaxation, body awareness, and emotional well-being through synchronised rhythm and breath.

Participants take part in a single session, delivered either in person (approximately 66 minutes) or online (approximately 33 minutes), depending on their assigned group. Both formats use live, interactive facilitation and follow the same sequence of musical and breathing exercises adapted to the delivery mode.
Experimental: Online The Concert Therapy Session
Single-session arts-based intervention delivered online through a live, interactive platform, featuring the same music, breathing, and movement structure as the in-person session.
Behavioral: The Concert Therapy

The Concert Therapy is an arts-based behavioural intervention integrating live music, guided breathing, and gentle movement. Each session follows a three-part structure designed to promote relaxation, body awareness, and emotional well-being through synchronised rhythm and breath.

Participants take part in a single session, delivered either in person (approximately 66 minutes) or online (approximately 33 minutes), depending on their assigned group. Both formats use live, interactive facilitation and follow the same sequence of musical and breathing exercises adapted to the delivery mode.

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
Change in Perceived Stress Scale (PSS-10) Score
Time Frame: Pre-session to immediately post-session (same day)
Change in participants' perceived stress levels measured by the 10-item Perceived Stress Scale (PSS-10) before and immediately after participation in The Concert Therapy session (in-person or online). Higher scores indicate greater stress.
Pre-session to immediately post-session (same day)

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
Participant Feedback on Emotional and Physical Well-being
Time Frame: Immediately post-session
Qualitative feedback collected after The Concert Therapy session, exploring participants' experiences of calmness, relaxation, enjoyment, and social connectedness. Responses will be analysed thematically.
Immediately post-session

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.
BeHnam KhodaRahmi

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.

Helpful Links

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 (Actual)

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.
November 14, 2025

Primary Completion (Actual)

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.
November 16, 2025

Study Completion (Actual)

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.
November 24, 2025

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).
November 14, 2025

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.
November 14, 2025

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.
November 19, 2025

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.
February 27, 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.
February 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.
February 1, 2026

More Information

Terms related to this study

Keywords

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.
  • TCT-BKH-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared; only aggregated, de-identified results will be published.

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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