Effects of Music Listening on Mood in an Inpatient Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single Case Experimental Design Study Exploring the Effect of Music in an Inpatient Neuropsychological Rehabilitation Setting

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Self-selected music


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants first complete a baseline phase before starting the intervention phase.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned. | |
| Experimental: Intervention<br>Participants will listen to music for 3 weeks. | Behavioral: Self-selected music<br>* Participants will be given iPods and headphones to listen to their music<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the CORE-10 mood screen | questionnaire measure of distress, functioning and risk | up to 6 weeks | 
| Change in self-report diary | will assess feasibility by examining how frequently the patients are listening to music | up to 6 weeks | 
| Change in self-report by therapists | Will help to assess patients' engagement in therapy before during and after intervention | up to 6 weeks | 
| 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. | up to 6 weeks | 
| 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 | up to 6 weeks | 
| 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. | up to 6 weeks |