Listening for Leisure After Stroke

NCT ID: NCT02259062

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music listening

Group Type: ACTIVE_COMPARATOR

Music listening alone

Intervention Type: OTHER

Music listening with brief mindfulness

Group Type: EXPERIMENTAL

Music with brief mindfulness intervention

Intervention Type: OTHER

Music listening with mindfulness therapy

Audio book intervention

Group Type: PLACEBO_COMPARATOR

Audiobook listening

Intervention Type: OTHER

Interventions

Music with brief mindfulness intervention

Music listening with mindfulness therapy

Intervention Type: OTHER

Music listening alone

Intervention Type: OTHER

Audiobook listening

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

GN13CP462

Identifier Type: -

Identifier Source: org_study_id