The Concert Therapy for Stress Regulation in a Non-Clinical Adult Population

NCT07430631 | Not Yet Recruiting

• 1 other identifier: TCT-RCT-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Regulation and Well-being in Non-clinical Contexts

Keywords

The Concert Therapy; stress regulation; well-being; arts-based intervention; music-based well-being; non-clinical study; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mood Visual Analogue Scales (VAS)

  Baseline (pre-session) to immediately post-session

• Well-being (WHO-5)

  Baseline (pre-session) to 1-week follow-up

• Perceived Stress Scale (PSS-10) at Follow-Up

  Baseline (pre-session) to 1 week follow-up

Other Outcomes (3)

• Depression, Anxiety and Stress Scale (DASS-21)

  Baseline (pre-session) to 1-week follow-up

• Heart Rate Variability (HRV)

  Baseline (pre-session) and immediately post-session

• Adverse Events and Safety

  Immediately post-session and at 1 week follow-up

Study Arms (2)

The Concert Therapy

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

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

Interventions

The Concert Therapy OTHER

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.

The Concert Therapy

Active Control: Relaxing Music and Quiet Rest OTHER

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.

Also known as: Active Control

Active Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Behnam Khodarahmi: lead

Study Sites (1)

The Concert Therapy

London, United Kingdom

Location

Central Study Contacts

Behnam Khodarahmi

CONTACT

+44 (0) 7767286336; email@behnamkhodarahmi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation. Participants and facilitators are not blinded due to the nature of the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Founder and Lead Researcher

Model Details: This is a two arm, parallel group randomised controlled trial with individual allocation to either the intervention or an active control condition.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: February 9, 2026
• Primary Completion: March 9, 2026
• Study Completion: March 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)