Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT07236918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Concert Therapy Pilot Study for Stress Reduction and Wellbeing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label study; no masking applied.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel cohorts receive the same arts-based intervention delivered via different formats: one in-person and one online. Pre-post within-group changes are evaluated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perceived Stress Scale (PSS-10) Score', 'timeFrame': 'Pre-session to immediately post-session (same day)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Participant Feedback on Emotional and Physical Well-being', 'timeFrame': 'Immediately post-session', 'description': "Qualitative feedback collected after The Concert Therapy session, exploring participants' experiences of calmness, relaxation, enjoyment, and social connectedness. Responses will be analysed thematically."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['The Concert Therapy', 'music therapy', 'arts-based intervention', 'breathing exercises', 'movement', 'stress', 'wellbeing', 'mental health', 'mindfulness', 'relaxation', 'live performance', 'pilot study'], 'conditions': ['Stress Reduction', 'Psychological Wellbeing', 'Mental Health', 'Music Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.theconcerttherapy.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nA 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years and older.\n\n* Able to understand and provide informed consent.\n* Willing and able to participate in a 60-minute in-person or 33-minute online session of The Concert Therapy.\n* Able to complete brief questionnaires in English before and after the session.\n\nExclusion Criteria:\n\n* Self-reported severe mental health conditions requiring medical treatment.\n* Significant hearing impairment that would limit engagement with music.\n* Inability to access the online platform (for online participants).\n* Previous participation in The Concert Therapy study.'}, 'identificationModule': {'nctId': 'NCT07236918', 'acronym': 'TCT', 'briefTitle': 'The Concert Therapy Pilot Study for Stress Reduction and Wellbeing', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Concert Therapy'}, 'officialTitle': 'The Concert Therapy: An Arts-Based Pilot Study on Music, Breathing, and Movement for Stress Reduction and Wellbeing', 'orgStudyIdInfo': {'id': 'TCT-BKH-2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-person The Concert Therapy Session', 'description': '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).', 'interventionNames': ['Behavioral: The Concert Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Online The Concert Therapy Session', 'description': '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.', 'interventionNames': ['Behavioral: The Concert Therapy']}], 'interventions': [{'name': 'The Concert Therapy', 'type': 'BEHAVIORAL', 'description': '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.\n\nParticipants 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.', 'armGroupLabels': ['In-person The Concert Therapy Session', 'Online The Concert Therapy Session']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Founder & Principle Investigator - The Concert Therapy', 'role': 'CONTACT', 'email': 'email@TheConcertTherapy.com', 'phone': '+447767286336'}], 'facility': 'The Concert Therapy', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Founder & Principle Investigator - The Concert Therapy', 'role': 'CONTACT', 'email': 'email@TheConcertTherapy.com', 'phone': '+447767286336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared; only aggregated, de-identified results will be published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeHnam KhodaRahmi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Founder & Principle Investigator', 'investigatorFullName': 'BeHnam KhodaRahmi', 'investigatorAffiliation': 'The Concert Therapy'}}}}