Listening for Leisure After Stroke (MELLO)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Music with brief mindfulness intervention
Music listening alone
Audiobook listening
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
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).
Sites / Locations
- NHS Greater Glasgow and Clyde
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Music listening
Music listening with brief mindfulness
Audio book intervention
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate at 6 month follow up from baseline
Treatment adherence at 6 month follow up from baseline
sample retention at 6 month follow up from baseline
Secondary Outcome Measures
Change in overall cognition score at 6 months from baseline
Change in attention, memory and executive function scores at 6 months from baseline
Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline
Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)
Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores
Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability
Changes in Metacognitions Questionnaire short form (MCQ-30)
Likert ratings of participants' and therapist's experiences of treatment delivery.
Full Information
NCT ID
NCT02259062
First Posted
October 3, 2014
Last Updated
July 5, 2016
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT02259062
Brief Title
Listening for Leisure After Stroke
Acronym
MELLO
Official Title
Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music listening
Arm Type
Active Comparator
Arm Title
Music listening with brief mindfulness
Arm Type
Experimental
Arm Title
Audio book intervention
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Music with brief mindfulness intervention
Intervention Description
Music listening with mindfulness therapy
Intervention Type
Other
Intervention Name(s)
Music listening alone
Intervention Type
Other
Intervention Name(s)
Audiobook listening
Primary Outcome Measure Information:
Title
Recruitment rate at 6 month follow up from baseline
Time Frame
6 months
Title
Treatment adherence at 6 month follow up from baseline
Time Frame
6 months
Title
sample retention at 6 month follow up from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in overall cognition score at 6 months from baseline
Time Frame
6 months
Title
Change in attention, memory and executive function scores at 6 months from baseline
Time Frame
6 months
Title
Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline
Time Frame
6 months
Title
Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)
Time Frame
6 months
Title
Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores
Time Frame
6 months
Title
Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability
Time Frame
6 months
Title
Changes in Metacognitions Questionnaire short form (MCQ-30)
Time Frame
6 months
Title
Likert ratings of participants' and therapist's experiences of treatment delivery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Evans, BSc,Dip.Clin.Psychol. PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
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Listening for Leisure After Stroke
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