Clinical trial NCT02259062: Listening for Leisure After Stroke
Official title: Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2014-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment rate at 6 month follow up from baseline
timeFrame: 6 months
measure: Treatment adherence at 6 month follow up from baseline
timeFrame: 6 months
measure: sample retention at 6 month follow up from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in overall cognition score at 6 months from baseline
timeFrame: 6 months
measure: Change in attention, memory and executive function scores at 6 months from baseline
timeFrame: 6 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline
timeFrame: 6 months
measure: Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)
timeFrame: 6 months
measure: Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores
timeFrame: 6 months
measure: Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability
timeFrame: 6 months
measure: Changes in Metacognitions Questionnaire short form (MCQ-30)
timeFrame: 6 months
measure: Likert ratings of participants' and therapist's experiences of treatment delivery.
timeFrame: 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: University of Glasgow
name: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD
role: PRINCIPAL_INVESTIGATOR
References: