title: Collaborative care for patients with bipolar disorder: a randomised controlled trial.
abstract: BACKGROUND
  Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands.
  
  
  METHODS
  The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC) in comparison with Care as usual (CAU) in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver outcomes are burden and satisfaction with care.
  
  
  CONCLUSIONS
  Several ways to enhance the quality of this study are described, as well as some limitations caused by the complexities of naturalistic treatment settings where not all influencing factors on an intervention and the outcomes can be controlled.
  
  
  BACKGROUND
  The Netherlands Trial Registry, NTR2600.
authors.affiliation: GGZ ingeest/VU University Medical Center, dept, of Psychiatry, Amsterdam, the Netherlands. n.vandervoort@ggzingeest.nl
authors.forename: Trijntje Y G
authors.initials: TY
authors.lastname: van der Voort
authors.forename: Berno
authors.initials: B
authors.lastname: van Meijel
authors.forename: Peter J J
authors.initials: PJ
authors.lastname: Goossens
authors.forename: Janwillem
authors.initials: J
authors.lastname: Renes
authors.forename: Aartjan T F
authors.initials: AT
authors.lastname: Beekman
authors.forename: Ralph W
authors.initials: RW
authors.lastname: Kupka
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000554:Ambulatory Care Facilities / Q000458:organization & administration*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000628:therapy*; D017028:Caregivers / Q000523:psychology; D002985:Clinical Protocols; D003299:Cooperative Behavior; D003362:Cost-Benefit Analysis; D006801:Humans; D008297:Male; D008605:Mental Health Services / Q000458:organization & administration*; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy / Q000628:therapy; D009426:Netherlands; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D010353:Patient Education as Topic; D010358:Patient Participation; D011569:Psychiatric Status Rating Scales; D055502:Secondary Prevention