MELLO: Listening for Leisure After Stroke

Sponsor

NHS Greater Glasgow and Clyde (Other)

Overall Status

Unknown status

CT.gov ID

NCT02259062

Collaborator

University of Glasgow (Other)

100

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 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

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

Recruitment rate at 6 month follow up from baseline [6 months]
Treatment adherence at 6 month follow up from baseline [6 months]
sample retention at 6 month follow up from baseline [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier:

NCT02259062

Other Study ID Numbers:

GN13CP462

First Posted:

Oct 8, 2014

Last Update Posted:

Jul 6, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 6, 2016