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Listening for Leisure After Stroke (MELLO)

NHS Trust logo

NHS Trust

Status

Unknown

Conditions

Stroke

Treatments

Other: Music listening alone
Other: Music with brief mindfulness intervention
Other: Audiobook listening

Study type

Interventional

Funder types

Other

Identifiers

NCT02259062
GN13CP462

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 3 patient groups, including a placebo group

Music listening
Active Comparator group
Treatment:
Other: Music listening alone
Music listening with brief mindfulness
Experimental group
Treatment:
Other: Music with brief mindfulness intervention
Audio book intervention
Placebo Comparator group
Treatment:
Other: Audiobook listening

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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