CClinicalTrials.gg
Status unknownNCT04431362Updated Feb 24, 2021

Effects of Music Listening on Mood in an Inpatient Rehabilitation

An interventional study of Self-selected music in Stroke, sponsored by King's College Hospital NHS Trust. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed.

Hypotheses:

  • The current intervention will be found to have a high feasibility.
  • Stroke patients will exhibit improved mood during the music listening intervention phase compared to their baseline phase.
  • Patients will show improvements in engagement in therapy if non-compliance was a previous issue (as demonstrated by therapist feedback regarding attendance of therapy sessions).
  • Patients will experience improved cognitive (memory) function (i.e. immediate and delayed free recall) during the intervention phase compared to baseline.
Read the detailed description

Stroke is one of the leading causes of disability in the world. Research has shown that in the aftermath of a stroke, patients continue to experience various impairments even years after the stroke. For example, research has shown that stroke survivors continue to experience both cognitive impairments (e.g. executive dysfunction) and low mood (e.g. depression) even after more than 5 years since the stroke has passed. A further study was able to link low mood with reduced engagement in therapy, which has been found to lead patients to experience less benefits from the given therapy.

Due to the lack of supporting evidence for pharmacological and psychological treatments, music intervention was introduced with positive results being reported in regards to patients' mood and cognitive abilities. For example, one study found that stroke patients who listened to self-selected music were likely to experience a significant improvement in their mood and cognitive abilities when compared to another group who listened to audiobooks.

The current study aims to build on previous research by utilising a novel study design that has not been previously used to assess the feasibility and effectiveness of music intervention on the mood of patients located at an inpatient rehabilitation unit. The chosen design, single-case experimental design, allows researchers to take into account the individual differences of the patients, which cannot be considered when using an experimental design which needs a group of similar characteristics. In addition, by using a non-concurrent multiple baseline design, the researchers will be able to show that any changes occurring to the target behaviour (mood) will be due to the intervention itself rather than any other extraneous variables found in the environment, as three different time lengths will be used for the baseline phase (5, 10, and 15 days). The aim of the study is to provide data that support the feasibility and effectiveness of music intervention as an inexpensive and simple method for improving mood in stroke patients at an inpatient rehabilitation unit. It also aims to show similar effectiveness in increasing cognitive impairment and therapy engagement.

02

Conditions studied

  • Stroke
03

In context

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 18 years or older
  • Good grasp of the English Language
  • Patients at the Frank Cooksey Rehabilitation Unit or transferring to the unit from an acute stroke ward
  • Recent diagnosis of stroke using MRI or CT scans
  • Low mood; will be confirmed by the clinical psychologist on the ward using mood screens as appropriate

Exclusion Criteria:- Severe or global aphasia, which interferes with their ability to understand instructions

  • Have a diagnosis of dementia
  • Patients who lack the capacity to consent

The study will also aim to exclude patients who have severe cognitive impairment, as assessed by the occupational therapists and clinical psychologist on the ward using screens or functional assessment as appropriate.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
5 participants (estimated)

Study arms

  • No intervention
    Baseline

    Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned.

  • Experimental
    Intervention

    Participants will listen to music for 3 weeks.

    Behavioral: Self-selected music

Interventions

  • BehavioralSelf-selected music

    Participants will be given iPods and headphones to listen to their music

06

What researchers measure

Primary outcomes

  1. Change in the CORE-10 mood screen

    questionnaire measure of distress, functioning and risk

    Time frame: up to 6 weeks

  2. Change in self-report diary

    will assess feasibility by examining how frequently the patients are listening to music

    Time frame: up to 6 weeks

  3. Change in self-report by therapists

    Will help to assess patients' engagement in therapy before during and after intervention

    Time frame: up to 6 weeks

  4. Change in the Montreal Cognitive Assessment

    Will help to explore changes in cognition before and after the intervention. Minimum value=0, maximum value=30, better scores mean better outcome.

    Time frame: up to 6 weeks

  5. Change in The Brain Injury Rehabilitation Trust Memory and Information Processing Battery (examines memory and information processing. Only the story recall subcategory will be used)

    Will help to explore changes in cognition (memory) before and after the intervention Minimum value=0, maximum value=60. Better scores mean better outcome

    Time frame: up to 6 weeks

  6. Change in the Mood Likert Scale

    Ad hoc scale made for the study for participants to rate their mood. It is a Likert scale (0 is very relaxed, 10 is very stressed). Higher score thus mean worse outcome.

    Time frame: up to 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003. PubMed 17903971 ↗
  • Dallery J, Cassidy RN, Raiff BR. Single-case experimental designs to evaluate novel technology-based health interventions. J Med Internet Res. 2013 Feb 8;15(2):e22. doi: 10.2196/jmir.2227. PubMed 23399668 ↗
  • Hammond MF, O'Keeffe ST, Barer DH. Development and validation of a brief observer-rated screening scale for depression in elderly medical patients. Age Ageing. 2000 Nov;29(6):511-5. doi: 10.1093/ageing/29.6.511. PubMed 11191243 ↗
  • Koorenhof L, Baxendale S, Smith N, Thompson P. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Seizure. 2012 Apr;21(3):178-82. doi: 10.1016/j.seizure.2011.12.001. Epub 2011 Dec 23. PubMed 22197200 ↗
  • Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15. PubMed 29253607 ↗
  • Ouellet MC, Morin CM. Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Arch Phys Med Rehabil. 2007 Dec;88(12):1581-92. doi: 10.1016/j.apmr.2007.09.006. PubMed 18047872 ↗
  • Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Aphasiology. 2016 Jul 2;30(7):862-876. doi: 10.1080/02687038.2016.1178022. Epub 2016 Apr 29. PubMed 27279674 ↗
  • Tunnard C, Wilson BA. Comparison of neuropsychological rehabilitation techniques for unilateral neglect: an ABACADAEAF single-case experimental design. Neuropsychol Rehabil. 2014;24(3-4):382-99. doi: 10.1080/09602011.2013.872041. Epub 2014 Jan 13. PubMed 24410191 ↗
  • Ayerbe L, Ayis S, Wolfe CD, Rudd AG. Natural history, predictors and outcomes of depression after stroke: systematic review and meta-analysis. Br J Psychiatry. 2013 Jan;202(1):14-21. doi: 10.1192/bjp.bp.111.107664. PubMed 23284148 ↗
  • Baylan S, McGinlay M, MacDonald M, Easto J, Cullen B, Haig C, Mercer SW, Murray H, Quinn TJ, Stott D, Broomfield NM, Stiles C, Evans JJ. Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke. Ann N Y Acad Sci. 2018 May 4. doi: 10.1111/nyas.13618. Online ahead of print. PubMed 29727009 ↗
  • Baylan S, Swann-Price R, Peryer G, Quinn T. The effects of music listening interventions on cognition and mood post-stroke: a systematic review. Expert Rev Neurother. 2016 Nov;16(11):1241-1249. doi: 10.1080/14737175.2016.1227241. Epub 2016 Aug 29. PubMed 27548875 ↗
  • Cumming TB, Churilov L, Linden T, Bernhardt J. Montreal Cognitive Assessment and Mini-Mental State Examination are both valid cognitive tools in stroke. Acta Neurol Scand. 2013 Aug;128(2):122-9. doi: 10.1111/ane.12084. Epub 2013 Feb 21. PubMed 23425001 ↗
  • Maclean N, Pound P, Wolfe C, Rudd A. Qualitative analysis of stroke patients' motivation for rehabilitation. BMJ. 2000 Oct 28;321(7268):1051-4. doi: 10.1136/bmj.321.7268.1051. PubMed 11053175 ↗
  • McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24. PubMed 21441153 ↗
  • 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. PubMed 18287122 ↗
  • Skidmore ER, Whyte EM, Holm MB, Becker JT, Butters MA, Dew MA, Munin MC, Lenze EJ. Cognitive and affective predictors of rehabilitation participation after stroke. Arch Phys Med Rehabil. 2010 Feb;91(2):203-7. doi: 10.1016/j.apmr.2009.10.026. PubMed 20159122 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04431362
Lead sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Mar 1, 2021 (estimated)
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Feb 24, 2021

Study contacts

Giulia Bellesi, DClinPsy
Contact
giulia.bellesi@nhs.net
01689866391
Giulia Bellesi, DClinPsy
principal investigator · King's College Hospital NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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