Music Listening for Mental Health Recovery After Stroke

New York University60 enrolled

Overview

This study aims to explore whether listening to music intentionally can support the mental health of people recovering from a stroke. The question the investigators aim to answer is: Can intentional music listening improve emotional well-being in stroke survivors? And if so, what kinds of changes might music listening induce in mental health, thinking and memory (cognition), and brain activity? Participants will be randomly assigned to listen to either music or an audiobook for one hour each day, at home, for four weeks. Participants will also attend four in-person sessions with the researchers: at the start of the study (baseline), just before the listening period begins, after the four weeks are complete, and at a follow-up. During these visits, researchers will gather information about participants' mood and mental health (via questionnaires), assess memory and attention (via cognitive tasks), and use MRI scans to look at brain activity.

This is a feasibility clinical trial of a remotely delivered music listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural, and physiological changes. Specifically, this is a parallel-group randomized controlled feasibility trial enrolling patients with chronic stroke. Participants will be randomized to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week pre-intervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (i.e., track identity, duration, and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioral outcomes related to mental health will be assessed at baseline, pre-intervention, post-intervention, and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity, and heart rate) will be collected pre- and post-intervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, fidelity, feasibility, acceptability, and burden. Secondary outcomes include recruitment and randomization rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for post-stroke mental health recovery.

Study Type

INTERVENTIONAL

Interventions

Intentional Music ListeningBEHAVIORAL

Participants will receive an iPad with Spotify (for music listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will listen to music for one hour per session, without multitasking (e.g., no chores or cooking), and will be encouraged to listen attentively. The investigators will collaborate with each participant to co-create a personalized playlist composed of self-selected, culturally relevant songs. This playlist can be updated at any time by the participant, either independently or with assistance from the team. During the music-listening session, participants will be on FaceTime with a team member, who will be available to provide support as needed. A custom Python script will continuously track the songs played by participants through Spotify, logging playback activity for research purposes.

Audiobook ListeningBEHAVIORAL

Participants will be provided with an iPad equipped with a Spotify (for audiobook listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will be asked to listen to an audiobook of their choice for one hour per session, without engaging in other activities such as chores or cooking. Participants will be instructed to listen attentively and avoid multitasking during the session. A team member will connect with each participant via FaceTime to offer support. Participants may update or change their audiobook selections at any time, either independently or with help from the team. A custom Python script will be used to continuously track audiobook playback activity for research and analysis.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants aged 50 to 90 * Confirmed diagnosis of ischemic or hemorrhagic stroke occurring at least six months prior to enrollment. Exclusion Criteria: * Significant hearing loss, defined by a score \>26 on the Hearing Handicap Inventory for the Elderly Screening (HHIE-S; Ventry and Weinstein, 1982) * Contraindications for MRI * Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) score below 22 (unless the lower score is attributable to expressive aphasia) * Specific musical anhedonia, defined as a score below 60 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013) * Amusia, defined as a score below 70% on the Montreal Battery of Evaluation of Amusia (MBEA; Peretz et al., 2003). * Participants will not be excluded if currently taking medications that may affect brain function (e.g., antidepressants) or if engaged in other complementary therapies (e.g., mindfulness, yoga). Participants will be allowed to initiate new medications or therapies during the study period.

Outcomes

Primary Outcomes

Burden (Completion of evaluation sessions)

Burden associated with each of the four evaluation sessions will be assessed. The outcome measure will include the proportion of patients who complete evaluations at each time point, with a target of at least 80% completion.

Time frame: From baseline to follow-up (3 months post-intervention)

Burden Ratings

Investigators will assess the perceived burden of participants by collecting at each evaluation session burden ratings. Participants will rate sessions as "not burdensome," "partially burdensome," or "very burdensome". The goal is for at least 80% of patients to rate the evaluations at each time point as "not burdensome. Burden ratings will be collected at 4 time points (baseline, pre-intervention, post-intervention and follow-up).

Time frame: From baseline to follow-up (3 months post-intervention)

Patient acceptability

After each listening session, participants will rate the session as "not acceptable," "partially acceptable," or "fully acceptable." The goal is for at least 80% of sessions to be rated as fully acceptable.

Time frame: From beginning to end of the intervention (4 weeks)

Retention and Adherence

Proportion of enrolled and randomized participants who complete the IML/Audiobook sessions. At least 80% of randomized patients complete at least 80% of the IML/Audiobook sessions.

Time frame: From beginning to end of the intervention (4 weeks)

Feasibility Ratings

Each listening session will be rated by the study team member leading the session as "not feasible," "partially feasible," or "fully feasible." The primary feasibility outcome measure is the proportion of sessions rated "fully feasible," with a target threshold of 80%.

Time frame: From beginning to the end of the intervention (4 weeks)

Fidelity

Fidelity will be measured as the the proportion of listening sessions delivered according to the protocol; video calls with patients will be recorded and a team member who was not present during the call will review the recordings and score the session as "delivered according to protocol" or "not delivered according to protocol". Benchmark for success: At least 80% of all sessions delivered according to the protocol.

Time frame: From beginning to the end of the intervention (4 weeks)

Secondary Outcomes

Recruitment

Recruitment will be measured by the number of participants successfully enrolled per month. The target benchmark is a minimum of 2 participants enrolled each month.

Time frame: Baseline

Randomization (Enrolment)

Randomization will be evaluated based on the proportion of screened participants who are successfully enrolled. The target benchmarks is for at least 30% of screened participants to be enrolled.

Time frame: Baseline

Randomization (Participation)

Randomization will be evaluated based on the proportion of enrolled participants who complete both the baseline and pre-intervention evaluations and attend at least one IML or Audiobook session. The target benchmark is for at least 80% of enrolled participants to reach this initial level of study engagement.

Time frame: Baseline, pre-intervention, and intervention