Music Listening for Mental Health Recovery After Stroke

Official title

Feasibility of a Music Listening Intervention for Mental Health Recovery in Chronic Stroke

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.

Detailed description

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.

Interventions

• Behavioral Intentional Music Listening
  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, eith
• Behavioral Audiobook Listening
  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. Participan

Primary outcome measures

• Burden (Completion of evaluation sessions) [Time frame: From baseline to follow-up (3 months post-intervention)]
• Burden Ratings [Time frame: From baseline to follow-up (3 months post-intervention)]
• Patient acceptability [Time frame: From beginning to end of the intervention (4 weeks)]
• Retention and Adherence [Time frame: From beginning to end of the intervention (4 weeks)]
• Feasibility Ratings [Time frame: From beginning to the end of the intervention (4 weeks)]
• Fidelity [Time frame: From beginning to the end of the intervention (4 weeks)]

Secondary outcome measures (3)

• Recruitment [Time frame: Baseline]
• Randomization (Enrolment) [Time frame: Baseline]
• Randomization (Participation) [Time frame: Baseline, pre-intervention, and intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• New York University — New York

Publications

• Sihvonen AJ, Leo V, Ripolles P, Lehtovaara T, Ylonen A, Rajanaro P, Laitinen S, Forsblom A, Saunavaara J, Autti T, Laine M, Rodriguez-Fornells A, Tervaniemi M, Soinila S, Sarkamo T. Vocal music enhances memory and language recovery after stroke: pooled results from two RCTs. Ann Clin Transl Neurol. 2020 Nov;7(11):2272-2287. doi: 10.1002/acn3.51217. Epub 2020 Oct 6. PMID 33022148
• Baylan S, Haig C, MacDonald M, Stiles C, Easto J, Thomson M, Cullen B, Quinn TJ, Stott D, Mercer SW, Broomfield NM, Murray H, Evans JJ. Measuring the effects of listening for leisure on outcome after stroke (MELLO): A pilot randomized controlled trial of mindful music listening. Int J Stroke. 2020 Feb;15(2):149-158. doi: 10.1177/1747493019841250. Epub 2019 Apr 2. PMID 30940047
• Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008 Mar;131(Pt 3):866-76. doi: 10.1093/brain/awn013. PMID 18287122
• Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26. PMID 28663005
• Provias V, Kucukoglu MA, Robinson A, Yandun-Oyola S, He R, Palumbo A, Sihvonen AJ, Shi Y, Malgaroli M, Schambra H, Fuentes M, Ripolles P. Remote intentional music listening intervention to support mental health in individuals with chronic stroke: study protocol for a feasibility trial. BMJ Open. 2025 Sep 18;15(9):e109467. doi: 10.1136/bmjopen-2025-109467. PMID 40973376
• Provias V, Kucukoglu MA, Robinson A, Yandun-Oyola S, He R, Palumbo A, Sihvonen AJ, Shi Y, Malgaroli M, Schambra H, Fuentes M, Ripolles P. Feasibility Trial Protocol for a Remote Intentional Music Listening Intervention to Support Mental Health in Individuals with Chronic Stroke. medRxiv [Preprint]. 2025 Aug 19:2025.08.15.25333806. doi: 10.1101/2025.08.15.25333806. PMID 40894150

Identifiers

NCT: NCT07127159 · FY2024-8826

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗