Stress Regulation and Well-being in Non-clinical ContextsTCT-RCTNCT07430631
The Concert Therapy for Stress Regulation in a Non-Clinical Adult Population
A study testing The Concert Therapy in people with Stress Regulation and Well-being in Non-clinical Contexts, run by Behnam Khodarahmi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Regulation and Well-being in Non-clinical Contexts
- What is being tested?
- The Concert Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2026to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Concert Therapy
London
Behnam Khodarahmi, +44 (0) 7767286336, email@behnamkhodarahmi.com
About this study
Official title: 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.
Read the 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.
- Being tested
- The Concert Therapy, Active Control: Relaxing Music and Quiet Rest
- Keywords
- The Concert Therapy, stress regulation, well-being, arts-based intervention, music-based well-being, non-clinical study, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Concert TherapyOther
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 Control: Relaxing Music and Quiet RestOther
Also called Active Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Active Control: Relaxing Music and Quiet Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
Self-reported perceived stress measured using the 10 item Perceived Stress Scale (PSS-10)
Measured: Baseline (pre-session) to immediately post-session
Secondary outcomes (3)
Mood Visual Analogue Scales (VAS)
Self-reported mood assessed using visual analogue scales (e.g. calm-tense, low-high energy)
Measured: 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)
Measured: 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)
Measured: Baseline (pre-session) to 1 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion9 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Regulation and Well-being in Non-clinical ContextsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two arm, parallel group randomised controlled trial with individual allocation to either the intervention or an active control condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Behnam Khodarahmi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Behnam Khodarahmi, The Concert Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430631
- Sponsor's protocol ID
- TCT-RCT-01
- Other IDs
- TCT-RCT-01
- Acronym
- TCT-RCT
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Concert Therapy: A Randomised Controlled Trial of a Non-Clinical, Arts-Based Well-being Intervention for Stress Regulation
- ClinicalTrials.gov ID
- NCT07430631
- Acronym / sponsor ID
- TCT-RCT / TCT-RCT-01
- Keywords
- The Concert Therapy, stress regulation, well-being, arts-based intervention, music-based well-being, non-clinical study, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Behnam KhodarahmiIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two arm, parallel group randomised controlled trial with individual allocation to either the intervention or an active control condition.
| Arm | Type | Receives |
|---|---|---|
| The Concert Therapy | Experimental | Other: The Concert TherapyParticipants 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. |
| Active Control | Active comparator | Other: Active Control: Relaxing Music and Quiet RestParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Concert TherapyThe 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. | Other | The Concert Therapy |
| Active Control: Relaxing Music and Quiet RestAlso: Active ControlThe 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 | Active Control |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: Baseline (pre-session) to immediately post-session
Self-reported perceived stress measured using the 10 item Perceived Stress Scale (PSS-10)
3 secondary outcomes
Mood Visual Analogue Scales (VAS)
Time frame: Baseline (pre-session) to immediately post-session
Well-being (WHO-5)
Time frame: Baseline (pre-session) to 1-week follow-up
Perceived Stress Scale (PSS-10) at Follow-Up
Time frame: Baseline (pre-session) to 1 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Concert Therapy in people with Stress Regulation and Well-being in Non-clinical Contexts, run by Behnam Khodarahmi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Behnam Khodarahmi (+44 (0) 7767286336, email@behnamkhodarahmi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: Baseline (pre-session) to immediately post-session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.