Listening for Leisure After Stroke

Study Overview
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Brief Summary
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Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation focuses primarily on physical disability and activities of daily living. By contrast, relatively little research attention has been paid to the potential for cognitive rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood and cognitive difficulties with attention and memory are common post stroke leading to poorer recovery, emotional wellbeing and quality of life yet accessible and effective therapies are lacking. Engagement in leisure activities may enhance recovery after stroke but participation in leisure activities is reduced following stroke. Music listening is a low cost and accessible leisure activity that has been suggested to improve mood and cognition poststroke. The investigators speculate that music listening may enhance control of attention in a similar way to mindfulness interventions, that have been demonstrated to be beneficial in the treatment of mood disorders. The investigators propose that adding a brief mindfulness intervention to music listening might enhance the effect on control of attention, with positive effects on cognition and mood poststroke but the feasibility and acceptability of this intervention needs to be evaluated before attempting a further trial assessing the effectiveness of this intervention. The investigators aim to recruit 100 patients within two weeks poststroke. Participants will be randomly assigned to receive an 8 week music listening alone, music listening with brief mindfulness or audiobook listening intervention alongside treatment as usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3 months, and 6 months poststroke In addition, participants will be interviewed about their experience of engaging in the interventions.

Official Title
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Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)

Conditions
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Stroke

Intervention / Treatment
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* Other: Music with brief mindfulness intervention
* Other: Music listening alone
* Other: Audiobook listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Ischaemic stroke (confirmed clinically and/or radiologically and subclassified according to the Oxford Clinical Stroke Classification) ≤14 days poststroke at time of recruitment (expression of interest to participate either verbally or in writing) Native English speaking Exclusion Criteria: Comorbid progressive neurological or neurodegenerative condition Major psychiatric disorder (Prestroke history of mood disorder or stable antidepressant medication will not lead to exclusion) History of major substance abuse problems Unable to give informed consent Unable to cooperate with the study protocol (e.g. due to severe aphasia, uncorrected impairment of hearing or vision, or illiteracy) Clinically unstable (e.g. due to major intercurrent illness).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music listening<br> | Other: Music listening alone<br> <br> |
| Experimental: Music listening with brief mindfulness<br> | Other: Music with brief mindfulness intervention<br>* Music listening with mindfulness therapy<br>|
| Placebo Comparator: Audio book intervention<br> | Other: Audiobook listening<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate at 6 month follow up from baseline |  | 6 months | 
| Treatment adherence at 6 month follow up from baseline |  | 6 months | 
| sample retention at 6 month follow up from baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall cognition score at 6 months from baseline |  | 6 months | 
| Change in attention, memory and executive function scores at 6 months from baseline |  | 6 months | 
| Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline |  | 6 months | 
| Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf) |  | 6 months | 
| Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores |  | 6 months | 
| Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability |  | 6 months | 
| Changes in Metacognitions Questionnaire short form (MCQ-30) |  | 6 months | 
| Likert ratings of participants' and therapist's experiences of treatment delivery. |  | 6 months |