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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

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 8, 2014
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
  • Recruitment rate at 6 month follow up from baseline [ Time Frame: 6 months ]
  • Treatment adherence at 6 month follow up from baseline [ Time Frame: 6 months ]
  • sample retention at 6 month follow up from baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02259062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
  • Change in overall cognition score at 6 months from baseline [ Time Frame: 6 months ]
  • Change in attention, memory and executive function scores at 6 months from baseline [ Time Frame: 6 months ]
  • Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline [ Time Frame: 6 months ]
  • Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf) [ Time Frame: 6 months ]
  • Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores [ Time Frame: 6 months ]
  • Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability [ Time Frame: 6 months ]
  • Changes in Metacognitions Questionnaire short form (MCQ-30) [ Time Frame: 6 months ]
  • Likert ratings of participants' and therapist's experiences of treatment delivery. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Listening for Leisure After Stroke
Official Title  ICMJE Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: Music with brief mindfulness intervention
    Music listening with mindfulness therapy
  • Other: Music listening alone
  • Other: Audiobook listening
Study Arms  ICMJE
  • Active Comparator: Music listening
    Intervention: Other: Music listening alone
  • Experimental: Music listening with brief mindfulness
    Intervention: Other: Music with brief mindfulness intervention
  • Placebo Comparator: Audio book intervention
    Intervention: Other: Audiobook listening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 7, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02259062
Other Study ID Numbers  ICMJE GN13CP462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NHS Greater Glasgow and Clyde
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE University of Glasgow
Investigators  ICMJE
Principal Investigator: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD University of Glasgow
PRS Account NHS Greater Glasgow and Clyde
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP