Listening for Leisure After Stroke

NCT02259062 | Unknown

• 1 other identifier: GN13CP462
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (3)

Music listening

ACTIVE COMPARATOR

Other: Music listening alone

Music listening with brief mindfulness

EXPERIMENTAL

Other: Music with brief mindfulness intervention

Audio book intervention

PLACEBO COMPARATOR

Other: Audiobook listening

Interventions

Music with brief mindfulness intervention OTHER

Music listening with mindfulness therapy

Music listening with brief mindfulness

Music listening alone OTHER

Music listening

Audiobook listening OTHER

Audio book intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Comorbid progressive neurological or neurodegenerative condition
• 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).

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Evans, BSc,Dip.Clin.Psychol. PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

GB (1)