Acquired Brain Injury (Including Stroke)NCT07568301
Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners
A study testing Nature in Harmony in people with Acquired Brain Injury (Including Stroke) and Caregivers, run by Duquesne University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury (Including Stroke), Caregivers
- What is being tested?
- Nature in Harmony
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Nature in Harmony
- Keywords
- music therapy, dyad intervention, nature-based
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature in HarmonyBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nature in Harmony |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First session to end of program approximately 4 weeks.
Secondary outcomes (6)
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.
Measured: First session to end of program approximately 4 weeks.
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.
Measured: First day to end of program approximately 4 weeks
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.
Measured: Last session, approximately 4 weeks after first session
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.
Measured: Every week for 4 weeks.
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.
Measured: Every week of the program for four weeks.
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.
Measured: Weekly journal entries for weeks 2,3, and 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start4 Mar 2026
- Primary completion21 May 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568301
- Sponsor's protocol ID
- 2025/11/22
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not included in the original IRB due to the small and local nature of the sample.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners
- ClinicalTrials.gov ID
- NCT07568301
- Acronym / sponsor ID
- 2025/11/22
- Keywords
- music therapy, dyad intervention, nature-based
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 21 May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 May 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nature In Harmony | Experimental | Behavioral: Nature in HarmonyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Nature in Harmony* 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 | Behavioural | Nature In Harmony |
Primary outcome
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.
6 secondary outcomes
The Connor-Davidson Resilience Scale
Time frame: First session to end of program approximately 4 weeks.
Dyadic Relationship Scale
Time frame: First day to end of program approximately 4 weeks
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Last session, approximately 4 weeks after first session
Attendance
Time frame: Every week for 4 weeks.
Accessibility of the strategies
Time frame: Every week of the program for four weeks.
Carryover of the strategies
Time frame: Weekly journal entries for weeks 2,3, and 4.
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 5 May 2026.
- Individual participant dataSharing planned: No. This was not included in the original IRB due to the small and local nature of the sample.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature in Harmony in people with Acquired Brain Injury (Including Stroke) and Caregivers, run by Duquesne University at 1 site in United States.
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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 5 May 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 States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUROHIS-QOL 8-item index (time frame: First session to end of program approximately 4 weeks.). 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 5 May 2026.