NCT07568301

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2026Jun 2026

Study Start

First participant enrolled

March 4, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

music therapydyad interventionnature-based

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (6)

  • The Connor-Davidson Resilience Scale

    First session to end of program approximately 4 weeks.

  • Dyadic Relationship Scale

    First day to end of program approximately 4 weeks

  • Client Satisfaction Questionnaire (CSQ-8)

    Last session, approximately 4 weeks after first session

  • Attendance

    Every week for 4 weeks.

  • Accessibility of the strategies

    Every week of the program for four weeks.

  • +1 more secondary outcomes

Study Arms (1)

Nature In Harmony

EXPERIMENTAL

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.

Behavioral: Nature in Harmony

Interventions

* Session 1- Duquesne University -120 minutes- Building Rapport: Psychoeducation on Music \& Nature * Session 2 - Duquesne University - 90 minutes - Using the Senses for Wellness * Session 3 - Duquesne University - 90 minutes - Connections \& Community * Session 4 - Frick Park Environmental Center - 4 Hours including Lunch - Self Care Immersion in Nature Retreat

Nature In Harmony

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15228, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 5, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

May 21, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This was not included in the original IRB due to the small and local nature of the sample.

Locations