- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568301
Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners
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:
- 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?
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?
- Attendance
- Satisfaction
- Accessibility
- Carryover of Strategies
Participants will complete self-reported surveys before and after completing 4 sessions of a nature & music-based program facilitated by occupational therapy and music therapy.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15228
- Duquesne University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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/or 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 23/35 on the MOCA or have a 5/6 on the Design Memory Test sub test of Cognition and Language Quick Test)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature In Harmony
The Nature in Harmony program involves four in-person sessions held at Duquesne University's campus using the outdoor pavilion and community garden with the final session occurring at Frick Park at their Environmental Center located in Pittsburgh, PA, between May and June of 2026.
Each session will have a minimum of two principal investigators to lead the activities.
Graduate assistants will be at each session to provide additional hands-on support for safety, mobility, and participant engagement.
Participants will be instructed to complete carryover activities between sessions: one to be completed together dyadically (person with ABI & care partner) and one to be completed individually.
Dyads will reflect on the experience in their activity journal and share and the beginning of sessions 2-4.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EUROHIS-QOL 8-item index
Time Frame: First session to end of program approximately 4 weeks.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Connor-Davidson Resilience Scale
Time Frame: First session to end of program approximately 4 weeks.
|
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.
|
First session to end of program approximately 4 weeks.
|
|
Dyadic Relationship Scale
Time Frame: First day to end of program approximately 4 weeks
|
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
|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Last session, approximately 4 weeks after first session
|
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
|
|
Attendance
Time Frame: Every week for 4 weeks.
|
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.
|
|
Accessibility of the strategies
Time Frame: Every week of the program for four weeks.
|
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.
|
|
Carryover of the strategies
Time Frame: Weekly journal entries for weeks 2,3, and 4.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/11/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caregivers
-
Istituto per la Ricerca e l'Innovazione BiomedicaAzienda Ospedaliero Universitaria Renato Dulbecco di CatanzaroActive, not recruitingCaregivers | Caregivers BurnoutItaly
-
Cairo UniversityCompletedPractices of Caregivers | Knowledge of Caregivers | Attitudes of Caregivers | Oral Health Status of Alzheimer PatientsEgypt
-
Social Insurance Institution, FinlandCompletedInformal Caregivers | Caregivers | Family CaregiversFinland
-
VA Office of Research and DevelopmentCompleted
-
University of MichiganNot yet recruitingCaregiversUnited States
-
Baylor College of MedicineThe University of Texas Health Science Center, Houston; National Institute...Not yet recruiting
-
University of MichiganCompletedCaregiversUnited States
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompleted
-
Lee KirbyIWK Health CentreCompleted
Clinical Trials on Nature in Harmony
-
Queen's University, BelfastCompletedAnxietyUnited Kingdom
-
Charite University, Berlin, GermanyRecruiting
-
University of TwenteCompletedHealthy | Spiritual Well-beingNetherlands
-
University of KarachiCompletedPost Traumatic Stress DisorderPakistan
-
Medtronic CardiovascularActive, not recruitingCongenital Heart Disease | Pulmonary Regurgitation | Tetrology of Fallot | RVOT AnomalyUnited States, Canada
-
Michigan State UniversityUniversity of Maryland; Medical College of Wisconsin; University of Virginia; University... and other collaboratorsCompletedMental HealthUnited States
-
McGill UniversitySocial Sciences and Humanities Research Council of CanadaCompleted
-
University of Vic - Central University of CataloniaBarcelona Institute for Global Health; Fundacio Salut i Envelliment UAB; Program...Active, not recruiting
-
University of Witten/HerdeckeCompletedStress | Self Efficacy | Resilience, Psychological | Goal Achievement | Well-Being, PsychologicalGermany
-
MindRhythm, Inc.Wayne State UniversityEnrolling by invitationStroke, AcuteUnited States