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


CONCLUSIONS
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.
Ballard
Clive
C
Wolfson Centre for Age Related Diseases, King's College London, Guy's Campus, London SE1 1UL, UK. clive.ballard@kcl.ac.uk
Brown
Richard
R
Fossey
Jane
J
Douglas
Simon
S
Bradley
Paul
P
Hancock
Judith
J
James
Ian A
IA
Juszczak
Edmund
E
Bentham
Peter
P
Burns
Alistair
A
Lindesay
James
J
Jacoby
Robin
R
O'Brien
John
J
Bullock
Roger
R
Johnson
Tony
T
Holmes
Clive
C
Howard
Robert
R
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use; D000077265:Donepezil; D005260:Female; D006707:Homes for the Aged; D006801:Humans; D007189:Indans / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D009735:Nursing Homes; D010880:Piperidines / Q000627:therapeutic use; D011595:Psychomotor Agitation / Q000523:psychology / Q000628:therapy*; D011613:Psychotherapy / Q000379:methods*; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil