Listening for Leisure After Stroke (MELLO)

July 5, 2016 updated by: NHS Greater Glasgow and Clyde

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

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.

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