- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02259062
Listening for Leisure After Stroke (MELLO)
Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom
- NHS Greater Glasgow and Clyde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Music listening
|
|
Experimental: Music listening with brief mindfulness
|
Music listening with mindfulness therapy
|
Placebo Comparator: Audio book intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recruitment rate at 6 month follow up from baseline
Time Frame: 6 months
|
6 months
|
Treatment adherence at 6 month follow up from baseline
Time Frame: 6 months
|
6 months
|
sample retention at 6 month follow up from baseline
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in overall cognition score at 6 months from baseline
Time Frame: 6 months
|
6 months
|
Change in attention, memory and executive function scores at 6 months from baseline
Time Frame: 6 months
|
6 months
|
Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline
Time Frame: 6 months
|
6 months
|
Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)
Time Frame: 6 months
|
6 months
|
Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores
Time Frame: 6 months
|
6 months
|
Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability
Time Frame: 6 months
|
6 months
|
Changes in Metacognitions Questionnaire short form (MCQ-30)
Time Frame: 6 months
|
6 months
|
Likert ratings of participants' and therapist's experiences of treatment delivery.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD, University of Glasgow
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN13CP462
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Music listening alone
-
Inonu UniversityCompletedCancer | ChemotherapyTurkey
-
Anglia Ruskin UniversityCompletedDepression | Stress | Anxiety | Visual Impairment | Low Vision | Emotional AdjustmentUnited Kingdom
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Erasmus Medical CenterNot yet recruiting
-
University of British ColumbiaNortheastern UniversityRecruiting
-
Turku University HospitalAcademy of FinlandCompleted
-
University Hospitals Cleveland Medical CenterKulas FoundationCompleted
-
University of British ColumbiaVancouver Coastal Health Research Institute; Mary Pack Research FundCompletedArthritis, Rheumatoid | Arthritis, Psoriatic | Spondylarthropathies | Inflammatory ArthritisCanada
-
The Hong Kong Polytechnic UniversityCompleted
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiEastern Mediterranean UniversityCompletedPain, Postoperative | Nursing Caries | Perioperative ComplicationTurkey