Dementia Collaborative Research Centre, Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, Australia.
BMJ Open. 2013 Jan 11;3(1):e002072. doi: 10.1136/bmjopen-2012-002072.
To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents.
The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy.
35 Sydney nursing homes.
All eligible residents within geographically defined areas within each nursing home were invited to participate.
Professional 'ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff 'LaughterBosses'. Controls received usual care.
Depression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment.
Sites were stratified by size and level of care then assigned to group using a random number generator.
Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045).
Humour therapy did not significantly reduce depression but significantly reduced agitation.
Australian New Zealand Clinical Trials Registry -ACTRN12611000462987.
确定幽默疗法是否能降低养老院居民的抑郁（主要结局）、躁动和行为障碍，并提高他们的社交参与度和生活质量。
悉尼多地点干预笑声老板和老年小丑研究是一项针对幽默疗法的单盲集群随机对照试验。
35 家悉尼养老院。
每个养老院的地理区域内的所有符合条件的居民都被邀请参加。
专业的“老年小丑”每周提供 9-12 次幽默疗法课程，由经过培训的工作人员“笑声老板”增强居民的参与度。对照组接受常规护理。
使用 Cornell 痴呆抑郁量表评估抑郁评分，使用 Cohen-Mansfield 躁动量表评估躁动评分，使用神经精神问卷评估行为障碍评分，使用多维老年人观察量表的退出子量表评估社交参与评分，使用痴呆症相关生活质量工具评估自我评估和代理评估的生活质量评分，多维观察量表。所有结果均由对分组不知情的研究人员在参与者层面进行测量。
根据规模和护理水平对地点进行分层，然后使用随机数发生器对组进行分组。
17 家养老院（189 名居民）接受了干预，18 家养老院（209 名居民）接受了常规护理。两组在主要结局抑郁方面，或在除躁动、社交参与和生活质量之外的行为障碍方面，随时间推移均无显著差异。在 26 周时，干预组的次要结局躁动显著低于对照组（经过协变量调整的时间与组间交互作用：p=0.011）。在经过协变量调整后，在 26 周时，以 Blom 转换后的躁动评分变化的平均差异为 0.17（95%CI 0.004 至 0.34，p=0.045）。
幽默疗法并未显著降低抑郁，但显著降低了躁动。
澳大利亚新西兰临床试验注册中心 -ACTRN12611000462987。
