title: Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: a protocol for a clustered, randomized clinical trial.
abstract: BACKGROUND
  Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice.
  
  
  METHODS
  In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption.
  
  
  CONCLUSIONS
  Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a study with sufficient statistical power to detect clinically relevant differences.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN13024375.
authors.affiliation: Son Serra- La Vileta Health Care Centre, Balearic Mental Health Research Group, Balearic Health service-IbSalut, Mallorca, Spain. cvicenscaldentey@ibsalut.caib.es
authors.forename: Caterina
authors.initials: C
authors.lastname: Vicens
authors.forename: Isabel
authors.initials: I
authors.lastname: Socias
authors.forename: Catalina
authors.initials: C
authors.lastname: Mateu
authors.forename: Alfonso
authors.initials: A
authors.lastname: Leiva
authors.forename: Ferran
authors.initials: F
authors.lastname: Bejarano
authors.forename: Ermengol
authors.initials: E
authors.lastname: Sempere
authors.forename: Josep
authors.initials: J
authors.lastname: Basora
authors.forename: Vicente
authors.initials: V
authors.lastname: Palop
authors.forename: Marta
authors.initials: M
authors.lastname: Mengual
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Beltran
authors.forename: Enric
authors.initials: E
authors.lastname: Aragonès
authors.forename: Guillem
authors.initials: G
authors.lastname: Lera
authors.forename: Silvia
authors.initials: S
authors.lastname: Folch
authors.forename: Josep Lluís
authors.initials: JL
authors.lastname: Piñol
authors.forename: Magdalena
authors.initials: M
authors.lastname: Esteva
authors.forename: Miguel
authors.initials: M
authors.lastname: Roca
authors.forename: Arturo
authors.initials: A
authors.lastname: Arenas
authors.forename: María
authors.initials: M
authors.lastname: Del Mar Sureda
authors.forename: Francisco
authors.initials: F
authors.lastname: Campoamor
authors.forename: Francisca
authors.initials: F
authors.lastname: Fiol
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000453:epidemiology; D001569:Benzodiazepines / Q000009:adverse effects*; D003863:Depression / Q000453:epidemiology; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D010353:Patient Education as Topic; D011320:Primary Health Care / Q000379:methods*; D012107:Research Design; D016037:Single-Blind Method; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control*; D019966:Substance-Related Disorders / Q000628:therapy*; D055815:Young Adult
chemical_list: D001569:Benzodiazepines