- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236918
The Concert Therapy Pilot Study for Stress Reduction and Wellbeing (TCT)
The Concert Therapy: An Arts-Based Pilot Study on Music, Breathing, and Movement for Stress Reduction and Wellbeing
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- The Concert Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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.
|
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
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
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
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCT-BKH-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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