Overview

This trial is active, not recruiting.

Condition stroke
Treatments music with brief mindfulness intervention, music listening alone, audiobook listening
Sponsor NHS Greater Glasgow and Clyde
Collaborator University of Glasgow
Start date October 2014
End date September 2016
Trial size 100 participants
Trial identifier NCT02259062, GN13CP462

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
music listening alone
(Experimental)
music with brief mindfulness intervention
Music listening with mindfulness therapy
(Placebo Comparator)
audiobook listening

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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).

Additional Information

Official title Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)
Principal investigator Jonathan Evans, BSc,Dip.Clin.Psychol. PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by NHS Greater Glasgow and Clyde.