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Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial)


Ballard, Clive, Brown, Richard, Fossey, Jane, Douglas, Simon, Bradley, Paul, Hancock, Judith, James, Ian A., Juszczak, Edmund, Bentham, Peter, Burns, Alistair, Lindesay, James, Jacoby, Robin, O'Brien, John, Bullock, Roger, Johnson, Tony, Holmes, Clive, Howard, Robert


The American Journal of Geriatric Psychiatry, Volume: 17, No.: 9, Pages.: 726-733

Year of Publication



Background: Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. Methods: At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Results: Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen- Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t 4.8, df 317, p < 0.0001). Therapy worksheets were completed in six of the eight centers, with the key elements of the intervention delivered according to the manual for > 95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t 6.5, df 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. Conclusion: The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST. (PsycINFO Database Record (c) 2013 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Ballard_2009, doi = {10.1097/jgp.0b013e3181b0f8c0}, url = {}, year = 2009, month = {sep}, publisher = {Elsevier {BV}}, volume = {17}, number = {9}, pages = {726--733}, author = {Clive Ballard and Richard Brown and Jane Fossey and Simon Douglas and Paul Bradley and Judith Hancock and Ian A. James and Edmund Juszczak and Peter Bentham and Alistair Burns and James Lindesay and Robin Jacoby and John O{textquotesingle}Brien and Roger Bullock and Tony Johnson and Clive Holmes and Robert Howard}, title = {Brief Psychosocial Therapy for the Treatment of Agitation in Alzheimer Disease (The {CALM}-{AD} Trial)}, journal = {The American Journal of Geriatric Psychiatry} }


agitated behavior therapy, agitation, alzheimer disease, alzheimer’s disease, brief psychosocial therapy, brief psychotherapy, drug therapy, psychological intervention, therapies sequence, timing of pharmacotherapy

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Cohort Study

Type of Outcomes


Type of Interventions

Non-pharmacological Treatment

Non-Pharmaceutical Interventions

Arts and Music Interventions (including Art and Music Therapy), Behavioural Therapies, Social activities (e.g. lunch clubs, cinema outings, trips to sporting events etc, peer support)