[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07568301":3,"trial-entities:NCT07568301":100,"trial-summary:NCT07568301":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":67,"minimum_age":68,"maximum_age":16,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":84,"locations":87,"central_contacts":96,"overall_officials":97,"references":98,"see_also_links":99},"NCT07568301","2025\u002F11\u002F22","Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners","ENROLLING_BY_INVITATION","2026-06","2026-04","2026-05-05","2026-03-04","Duquesne University","OTHER",false,"The goal of this pilot study is to determine the initial impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature \\& music-based program facilitated by occupational therapy and music therapy. The main questions it aims to answer are:\n\n* Primary Question: What is the impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature \\& music-based program facilitated by occupational therapy and music therapy?\n* Secondary Question: What is the feasibility of a four-session nature \\& music-based wellness program for clients with acquired brain injury and care partner dyads?\n\n  * Attendance\n  * Satisfaction\n  * Accessibility\n  * Carryover of Strategies\n\nParticipants will complete self-reported surveys before and after completing 4 sessions of a nature \\& music-based program facilitated by occupational therapy and music therapy.",null,[18,19],"Acquired Brain Injury (Including Stroke)","Caregivers",[21,22,23],"music therapy","dyad intervention","nature-based","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},10,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Nature in Harmony","* Session 1- Duquesne University -120 minutes- Building Rapport: Psychoeducation on Music \\& Nature\n* Session 2 - Duquesne University - 90 minutes - Using the Senses for Wellness\n* Session 3 - Duquesne University - 90 minutes - Connections \\& Community\n* Session 4 - Frick Park Environmental Center - 4 Hours including Lunch - Self Care Immersion in Nature Retreat",[37],"Nature In Harmony",[39],{"measure":40,"description":41,"timeFrame":42},"EUROHIS-QOL 8-item index","EUROHIS-QOL 8 is a standardized assessment of general quality of life that assesses four domains of QOL: physical, psychological, social, and environmental. This assessment has been validated for persons with traumatic brain injury (Balalla et al., 2019). This is 5-point scale from \"not at all\" to \"completely.\" A high total point value indicates a better quality of life rating.","First session to end of program approximately 4 weeks.",[44,47,51,55,59,63],{"measure":45,"description":46,"timeFrame":42},"The Connor-Davidson Resilience Scale","The 10-item Connor-Davidson Resilience Scale will be administered as a secondary outcome to determine if any impacts are seen after this brief program because of participation. This measure has been used with persons post-traumatic brain injury, stroke, and caregivers. Rating scale goes from 0-4 with higher total scores indicating better resilence.",{"measure":48,"description":49,"timeFrame":50},"Dyadic Relationship Scale","The 10-item Dyadic Relationship Scale will be administered as a secondary outcome to examine any changes in both positive and negative interactions between individuals with ABI and their care partners after this program (Sebern \\& Whitlatch, 2007). This is a four point scale with a higher score indicating more negative dyad experiences.","First day to end of program approximately 4 weeks",{"measure":52,"description":53,"timeFrame":54},"Client Satisfaction Questionnaire (CSQ-8)","This measure uses eight questions on a four point Likert-scale strongly agree to strongly disagree to assess participants' overall satisfaction with the program with a maximum score of 32 (Attkisson \\& Greenfield, 2004). The average score for the group on the CSQ-8 is at least 24.","Last session, approximately 4 weeks after first session",{"measure":56,"description":57,"timeFrame":58},"Attendance","Session attendance will be tracked at every session throughout the program as either present \"1\" or absent \"0\". Participants who attend all sessions will have a total of 4.","Every week for 4 weeks.",{"measure":60,"description":61,"timeFrame":62},"Accessibility of the strategies","4-point Likert scale survey will be used to document participants' interest in using the covered strategies in the sessions. Items will not be totaled and scales vary by question.","Every week of the program for four weeks.",{"measure":64,"description":65,"timeFrame":66},"Carryover of the strategies","A self-reported journal includes date, the name of the activity, length, and personnels will be provided for documenting the carryover activities outside of the session time.","Weekly journal entries for weeks 2,3, and 4.","ALL","18 Years",true,{"inclusion":71,"exclusion":78,"raw_text":83},[72,73,74,75,76,77],"All participants must be above the age of 18 to participate.","Able to communicate in English","A person with an ABI can include persons with a diagnosis of traumatic brain injury, stroke, aneurysm, brain infection, and\u002For brain cancer.","A care partner is broadly defined as a social support person who has been identified as a family member or friend of the person with the acquired brain injury.","Capacity for consent - Person must be their own medical power of attorney","Capacity for Self-Reflection (have a score of 23\u002F35 on the MOCA or have a 5\u002F6 on the Design Memory Test sub test of Cognition and Language Quick Test)",[79,80,81,82],"Self-reported severe-to profound hearing loss with the use of hearing aid(s)","Cannot communicate in English","Have a diagnosis of a progressive neurological disorder, such as Amyotrophic lateral sclerosis, Parkinson's disease, Dementia, Multiple Sclerosis","Have a severe aphasia","Inclusion Criteria:\n\n* All participants must be above the age of 18 to participate.\n* Able to communicate in English\n* A person with an ABI can include persons with a diagnosis of traumatic brain injury, stroke, aneurysm, brain infection, and\u002For brain cancer.\n* A care partner is broadly defined as a social support person who has been identified as a family member or friend of the person with the acquired brain injury.\n* Capacity for consent - Person must be their own medical power of attorney\n* Capacity for Self-Reflection (have a score of 23\u002F35 on the MOCA or have a 5\u002F6 on the Design Memory Test sub test of Cognition and Language Quick Test)\n\nExclusion Criteria:\n\n* Self-reported severe-to profound hearing loss with the use of hearing aid(s)\n* Cannot communicate in English\n* Have a diagnosis of a progressive neurological disorder, such as Amyotrophic lateral sclerosis, Parkinson's disease, Dementia, Multiple Sclerosis\n* Have a severe aphasia",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":12,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Pittsburgh","Pennsylvania","15228","United States",{"lat":94,"lon":95},40.44062,-79.99589,[],[],[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102,19],"Brain Injury",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]