跳至主要内容
临床试验/NCT02259062
NCT02259062Unknown不适用

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

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Recruitment rate at 6 month follow up from baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

Recruitment rate at 6 month follow up from baseline

时间窗: 6 months

Treatment adherence at 6 month follow up from baseline

时间窗: 6 months

sample retention at 6 month follow up from baseline

时间窗: 6 months

次要结局

  • Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability(6 months)
  • Changes in Metacognitions Questionnaire short form (MCQ-30)(6 months)
  • Likert ratings of participants' and therapist's experiences of treatment delivery.(6 months)
  • Change in attention, memory and executive function scores at 6 months from baseline(6 months)
  • Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores(6 months)
  • Change in overall cognition score 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验