Listening for Leisure After Stroke

Stroke Clinical Trial

— MELLO  

Official title:

Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02259062
• Other study ID #: GN13CP462
• Status: Active, not recruiting
• Phase: N/A
• First received: October 3, 2014
• Last updated: July 5, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Music with brief mindfulness intervention
Music listening with mindfulness therapy
• Music listening alone

• Audiobook listening

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate at 6 month follow up from baseline		6 months	No
Primary	Treatment adherence at 6 month follow up from baseline		6 months	No
Primary	sample retention at 6 month follow up from baseline		6 months	No
Secondary	Change in overall cognition score at 6 months from baseline		6 months	No
Secondary	Change in attention, memory and executive function scores at 6 months from baseline		6 months	No
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline		6 months	No
Secondary	Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)		6 months	No
Secondary	Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores		6 months	No
Secondary	Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability		6 months	No
Secondary	Changes in Metacognitions Questionnaire short form (MCQ-30)		6 months	No
Secondary	Likert ratings of participants' and therapist's experiences of treatment delivery.		6 months	No