The Concert Therapy for Stress Regulation in a Non-Clinical Adult Population (TCT-RCT)

The Concert Therapy: A Randomised Controlled Trial of a Non-Clinical, Arts-Based Well-being Intervention for Stress Regulation

The Concert Therapy is a non-clinical, art based well-being intervention designed to support stress regulation through a structured, concert like experience. The intervention integrates three sequential phases: calming music, guided breathing with gentle movement, and uplifting music. It is intended for use with adults experiencing everyday stress in non-clinical contexts and does not involve diagnosis or treatment.

This randomised controlled trial will compare The Concert Therapy with an active control condition consisting of relaxing music listening and quiet rest. Adult participants will be randomly assigned to one of the two conditions. The primary outcome is change in self-reported perceived stress measured before and immediately after the session. Secondary outcomes include mood and short term follow-up measures of well-being and stress.

The study aims to examine whether the structured, three phase design of The Concert Therapy leads to greater improvements in perceived stress compared with non-specific relaxation and music listening alone. The trial is designed as a non-clinical well-being study and does not constitute a clinical treatment trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Regulation and Well-being in Non-clinical Contexts
• Intervention / Treatment: Other: The Concert Therapy; Other: Active Control: Relaxing Music and Quiet Rest

Detailed Description

This study is a randomised controlled trial designed to evaluate a non-clinical, arts based well-being intervention known as The Concert Therapy. The study focuses on stress regulation and well-being in adults experiencing everyday stress in non-clinical contexts. The trial does not involve diagnosis, treatment, or clinical decision making and is not intended as a form of therapy or medical intervention.

The Concert Therapy is delivered as a single, structured session presented in a concert like format. The intervention follows a three phase sequence intended to support regulation through musical and embodied experience. The first phase involves calming music designed to support settling and relaxation. The second phase integrates guided breathing with gentle, optional movement to support embodied regulation and sustained presence. The third phase involves uplifting music intended to support gentle re-activation and a sense of closure. The session is facilitated in a group setting and may be delivered in person or online, depending on context.

Participants randomised to the intervention arm will attend one session of The Concert Therapy. Participants randomised to the control arm will attend a session of equivalent duration and setting involving relaxing music listening and quiet rest. The control condition is designed to match time, environment, and exposure to music while omitting the structured three phase sequence, guided breathing, and movement elements of The Concert Therapy.

Participants will complete self-report measures of perceived stress and mood before the session and immediately after the session. A short follow-up assessment will be conducted one week later to explore short term maintenance of effects. Adverse events and safety information will be collected after the session and at follow-up using a simple checklist.

The primary outcome of the study is change in self-reported perceived stress from baseline to immediately after the session. Secondary outcomes include changes in mood and well-being, as well as perceived stress at one week follow-up. Additional exploratory measures may be collected to support a broader understanding of participant experience and feasibility.

The study is designed to examine whether participation in The Concert Therapy is associated with greater improvements in perceived stress compared with an active control condition. All participants retain full autonomy over their level of engagement and may withdraw from the study at any time. The trial follows established ethical principles for research involving human participants.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Behnam Khodarahmi; Phone Number: +44 (0) 7767286336; Email: email@behnamkhodarahmi.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • The Concert Therapy
    • Contact: Behnam Khodarahmi; Phone Number: +44 (0) 7767286336; Email: email@behnamkhodarahmi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 18 to 65 years
• Experiencing self-reported everyday stress in non-clinical contexts
• Able to participate in gentle movement and remain seated or standing for the duration of the session
• Able to understand the study information and provide informed consent

Exclusion Criteria:

• Current treatment for serious cardiovascular or respiratory illness
• Current use of medication that directly affects heart rate or stress response (for example, beta-blockers)
• Pregnancy
• Severe psychiatric illness requiring intensive treatment
• Inability to understand the language used for the intervention and study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Concert Therapy; Participants will attend a single session of The Concert Therapy, a non-clinical, arts based well-being intervention delivered in a concert like format. The session follows a structured three phase sequence consisting of calming music, guided breathing with gentle movement, and uplifting music.	Other: The Concert Therapy; The Concert Therapy is a non-clinical, arts based well-being intervention delivered as a single, structured session in a concert-like format. The session follows a three phase sequence consisting of calming music, guided breathing with gentle movement, and uplifting music. The intervention is designed to support stress regulation and well-being in adults experiencing everyday stress in non-clinical contexts.
Active Comparator: Active Control; Participants will attend a single session of relaxing music listening and quiet rest in a similar setting and for a similar duration as the intervention arm. The session does not include the structured three phase sequence, guided breathing, or movement.	Other: Active Control: Relaxing Music and Quiet Rest; The active control condition consists of a single session of relaxing music listening and quiet rest delivered in a similar setting and for a similar duration as the intervention arm. The session does not include the structured three phase sequence, guided breathing, or movement elements of The Concert Therapy.; Other Names: Active Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS-10)	Self-reported perceived stress measured using the 10 item Perceived Stress Scale (PSS-10)	Baseline (pre-session) to immediately post-session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood Visual Analogue Scales (VAS)	Self-reported mood assessed using visual analogue scales (e.g. calm-tense, low-high energy)	Baseline (pre-session) to immediately post-session
Well-being (WHO-5)	Self-reported well-being measured using the World Health Organization Well-Being Index (WHO-5)	Baseline (pre-session) to 1-week follow-up
Perceived Stress Scale (PSS-10) at Follow-Up	Self-reported perceived stress measured using the 10 item Perceived Stress Scale (PSS-10)	Baseline (pre-session) to 1 week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety and Stress Scale (DASS-21)	Self-reported emotional states measured using the 21 item Depression, Anxiety and Stress Scale (DASS-21) for exploratory, non-diagnostic purposes	Baseline (pre-session) to 1-week follow-up
Heart Rate Variability (HRV)	Physiological measure of heart rate variability recorded at rest for exploratory purposes	Baseline (pre-session) and immediately post-session
Adverse Events and Safety	Self-reported adverse events and safety information collected using a brief checklist	Immediately post-session and at 1 week follow-up

Collaborators and Investigators

• Sponsor: BeHnam KhodaRahmi

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): March 9, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: well-being; randomised controlled trial; stress regulation; The Concert Therapy; arts-based intervention; music-based well-being; non-clinical study
• Other Study ID Numbers: TCT-RCT-01 (Other Identifier: The Concert Therapy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a small, non-clinical study involving sensitive self-reported well-being information. Data will be analysed and reported in aggregate form only to protect participant privacy and confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No