Objectives: To determine whether humour therapy
reduces depression (primary outcome), agitation and
behavioural disturbances and improves social
engagement and quality-of-life in nursing home
Design: The Sydney Multisite Intervention of
LaughterBosses and ElderClowns study was a singleblind
cluster randomised controlled trial of humour
Setting: 35 Sydney nursing homes.
Participants: All eligible residents within geographically
defined areas within each nursing home were invited to
Intervention: Professional ‘ElderClowns’ provided
9–12 weekly humour therapy sessions, augmented by
resident engagement by trained staff ‘LaughterBosses’.
Controls received usual care.
Measurements: 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.
Randomisation: Sites were stratified by size and level
of care then assigned to group using a random number
Results: 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).
Conclusions: Humour therapy did not significantly
reduce depression but significantly reduced agitation.