Listening for Leisure After Stroke (MELLO)

• ClinicalTrials.gov Identifier: NCT02259062
• Recruitment Status: Unknown
• First Posted: October 8, 2014
• Last Update Posted: July 6, 2016
• Sponsor: NHS Greater Glasgow and Clyde
• Collaborator: University of Glasgow
• Information provided by (Responsible Party): NHS Greater Glasgow and Clyde

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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).

Contacts and Locations

Locations

United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

University of Glasgow

Investigators

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

More Information

• Responsible Party: NHS Greater Glasgow and Clyde
• ClinicalTrials.gov Identifier: NCT02259062
• Other Study ID Numbers: GN13CP462
• First Posted: October 8, 2014
• Last Update Posted: July 6, 2016
• Last Verified: July 2016

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases