Brief Psychosocial Therapy for the Treatment of Agitation in Alzheimer Disease (The CALM-AD Trial)

• Published in: The American journal of geriatric psychiatry 2009-09, Vol.17 (9), p.726-733
• Main Authors: Ballard, Clive, M.R.C. Psych., M.D, Brown, Richard, Ph.D, Fossey, Jane, M.Sc, Douglas, Simon, M.Sc, Bradley, Paul, B.Sc, Hancock, Judith, M.Sc, James, Ian A., Ph.D, Juszczak, Edmund, M.Sc, Bentham, Peter, M.B.Ch.B., M.R.C. Psych., M.Med.Sc, Burns, Alistair, M.D. (Hons), Lindesay, James, D.M., F.R.C. Psych, Jacoby, Robin, D.M., F.R.C.P, O'Brien, John, D.M, Bullock, Roger, M.R.C. Psych, Johnson, Tony, Ph.D, Holmes, Clive, Ph.D, Howard, Robert, M.R.C. Psych
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Agitation; Alzheimer disease; Alzheimer Disease - physiopathology; Alzheimer Disease - psychology; Alzheimer Disease - therapy; Cholinesterase Inhibitors - therapeutic use; Female; Homes for the Aged; Humans; Indans - therapeutic use; Internal Medicine; Male; Middle Aged; Neuropsychological Tests; Nursing Homes; Piperidines - therapeutic use; psychological intervention; Psychomotor Agitation - psychology; Psychomotor Agitation - therapy; Psychotherapy - methods; Treatment Outcome
• ISSN: 1064-7481; 1545-7214
• DOI: 10.1097/JGP.0b013e3181b0f8c0

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.