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Listening for Leisure After Stroke (MELLO)

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ClinicalTrials.gov Identifier: NCT02259062
Recruitment Status : Unknown
Verified July 2016 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Stroke Other: Music with brief mindfulness intervention Other: Music listening alone Other: Audiobook listening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Active Comparator: Music listening Other: Music listening alone
Experimental: Music listening with brief mindfulness Other: Music with brief mindfulness intervention
Music listening with mindfulness therapy

Placebo Comparator: Audio book intervention Other: Audiobook listening



Primary Outcome Measures :
  1. Recruitment rate at 6 month follow up from baseline [ Time Frame: 6 months ]
  2. Treatment adherence at 6 month follow up from baseline [ Time Frame: 6 months ]
  3. sample retention at 6 month follow up from baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in overall cognition score at 6 months from baseline [ Time Frame: 6 months ]
  2. Change in attention, memory and executive function scores at 6 months from baseline [ Time Frame: 6 months ]
  3. Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline [ Time Frame: 6 months ]
  4. Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf) [ Time Frame: 6 months ]
  5. Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores [ Time Frame: 6 months ]
  6. Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability [ Time Frame: 6 months ]
  7. Changes in Metacognitions Questionnaire short form (MCQ-30) [ Time Frame: 6 months ]
  8. Likert ratings of participants' and therapist's experiences of treatment delivery. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259062


Locations
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United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD University of Glasgow

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02259062     History of Changes
Other Study ID Numbers: GN13CP462
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases