Listening for Leisure After Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Other: Music listening alone; Other: Music with brief mindfulness intervention; Other: Audiobook listening

• Registration Number: NCT02259062
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-06
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music listening	Music listening alone	-
Music listening with brief mindfulness	Music with brief mindfulness intervention	-
Audio book intervention	Audiobook listening	-

Primary Outcome Measures

Name	Time	Method
Treatment adherence at 6 month follow up from baseline	6 months
Recruitment rate at 6 month follow up from baseline	6 months
sample retention at 6 month follow up from baseline	6 months

Secondary Outcome Measures

Name	Time	Method
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
Change in attention, memory and executive function scores at 6 months from baseline	6 months
Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores	6 months
Change in overall cognition score 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

Trial Locations

Locations (1)

NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom