title: Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).
abstract: 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.
authors.affiliation: Wolfson Centre for Age Related Diseases, King's College London, Guy's Campus, London SE1 1UL, UK. clive.ballard@kcl.ac.uk
authors.forename: Clive
authors.initials: C
authors.lastname: Ballard
authors.forename: Richard
authors.initials: R
authors.lastname: Brown
authors.forename: Jane
authors.initials: J
authors.lastname: Fossey
authors.forename: Simon
authors.initials: S
authors.lastname: Douglas
authors.forename: Paul
authors.initials: P
authors.lastname: Bradley
authors.forename: Judith
authors.initials: J
authors.lastname: Hancock
authors.forename: Ian A
authors.initials: IA
authors.lastname: James
authors.forename: Edmund
authors.initials: E
authors.lastname: Juszczak
authors.forename: Peter
authors.initials: P
authors.lastname: Bentham
authors.forename: Alistair
authors.initials: A
authors.lastname: Burns
authors.forename: James
authors.initials: J
authors.lastname: Lindesay
authors.forename: Robin
authors.initials: R
authors.lastname: Jacoby
authors.forename: John
authors.initials: J
authors.lastname: O'Brien
authors.forename: Roger
authors.initials: R
authors.lastname: Bullock
authors.forename: Tony
authors.initials: T
authors.lastname: Johnson
authors.forename: Clive
authors.initials: C
authors.lastname: Holmes
authors.forename: Robert
authors.initials: R
authors.lastname: Howard
mesh_terms: 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
chemical_list: D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil