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

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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.

Section snippets

METHODS

The original trial design was a multicenter 12-week blinded randomized three-arm (risperidone, donepezil, or placebo) parallel group clinical trial, preceded by 4 weeks psychosocial treatment. Recruitment started in November 2003 but was suspended on March 8, 2004, after the release of advice by the United Kingdom Committee for Safety of Medicines that the atypical antipsychotics risperidone and olanzapine should not be used for the treatment of behavioral symptoms in dementia because of

RESULTS

Five hundred nine patients were identified as eligible between November 2003 and December 2005, of whom 87 patients (17.1%) did not give consent for inclusion beyond initial screening and 35 preceded directly to the randomized controlled trial of donepezil, either because of the perceived severity of the agitation (N = 18) or because people were living in their own homes (N = 17). Three hundred eighty-seven patients entered the BPST phase of the study of whom 318 patients (82%) completed the

DISCUSSION

There was a significant 5.6 point reduction in the total CMAI in the 318 patients completing BPST and a similar 6.6 point reduction in the total CMAI in the 198 patients where more detailed evaluation of the quality of the BPST was possible, with 43% of patients experiencing a 30% improvement in their level of agitation. Significant improvement was evident in each of the major agitation syndromes, including aggression, restlessness, and nonaggressive verbal agitation. In the absence of a

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    This work was supported by the Medical Research Council (UK), the Alzheimer's Society (UK), and Department of Health (the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health).

    Study Centers: Section of Old Age Psychiatry, Institute of Psychiatry, King's College London (Julia DeCesare and Michaela Rodger Trial Managers, Dr. Louisa Beckford, Dr. Lydia Chambers, Gaynor Vere, Angela Snook, Amy Langman, Anna Oldershaw); Queen Elizabeth Psychiatric Hospital, Birmingham (Dr. Rhiannon Callaghan, Jan Wright, Analisa Smythe); Leicester (Sarah Baillon, Dr. Darren Malone, Penny Wakefield); Division of Psychiatry, University of Manchester, Wythenshawe Hospital, Manchester (Deborah Duignan, Dr. Salman Karim); Institute for Ageing and Health, Newcastle (Leslie Lee, Ruth Elvish, Dr. Mani Krishnan, Cassie Partington, Gemma Hunter, Dr. Mani Bhasin, Dr. Anuna Ravishankar); Oxford (Mary Clarke, Lesley Daniels); Memory Assessment and Research Centre, Southampton (Christine Dean, Elizabeth Finbow); Kingshill Research Centre, Victoria Hospital, Swindon. MRC Clinical Trials Unit: Sinead Nally, Susan Tebbs, Angela, Poland, Debbie Johnson.

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