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ISRCTN
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ISRCTN13024375
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ClinicalTrials.gov identifier
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Public title
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Clinical trial on the efficacy of two interventions for discontinuing long term benzodiazepine use in primary care
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Scientific title
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A cluster randomised controlled trial on the efficacy of a structured educational intervention or minimal intervention versus usual care for discontinuing long term benzodiazepine use in primary care
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Acronym
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BENZORED
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Serial number at source
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PS09/00947
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Study hypothesis
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Although short-term efficacy of benzodiazepines (BZD) is well established, long-term efficacy remains controversial and long term use is usually not recomended because of potential adverse effects and the risks of tolerance and dependence, increased risk of hip fractures, motor vehicle accidents and memory impairments. Most guidelines recommend restricting their use to short periods only, but nevertheless they are widely prescribed.
Objective:
To evaluate the efficacy of a structured educative intervention (SEI) and of a minimal intervention (MI) performed by the family General Practitioner (GP) to discontinue long term BZD use, compared to usual care. To evaluate the safety of these interventions in anxiety and depression symptoms, sleep quality and alcohol consumption.
Hypotheses:
1. In primary care patients on long-term benzodizapine, a structured educational intervention results in a cessation rate of 40% after one year, compared to 25% with minimal intervention and less than 10% with usual care
2. The interventions proposed (EI and MI) do not induce more symptoms of anxiety and depression or affect quality of sleep and alcohol consumption compared to the control group
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Ethics approval
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The Ethics Committee of the Balearic Islands (Comité Ético Investigación Clínica [CEIC])approved on the 29th April 2009
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Study design
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Multicentre cluster randomised controlled three-arm parallel group trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Benzodiazepine use, reduction and withdrawal
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Participants - inclusion criteria
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1. Patients between 18 and 80 years
2. Recorded history of benzodiazepine consumption or an analogue at least 5 times a week for at least six months
3. A minimum of 6 months prescription of a benzodiazepine or similar
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Participants - exclusion criteria
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1. Patients with severe anxiety or depressive disorder, psychotic disorder, severe personality disorder, and/or psychiatric monitoring
2. Patients with cognitive impairment, terminal illness or serious medical conditions, illegal drug use or abuse alcohol, inability to sign informed consent
3. Institutionalised patients
4. Patients with exacerbation of symptoms of anxiety/depression whose doctor considers that the withdrawal of a benzodiazepine can be harmful at this time
5. Patients with limited capacity for understanding
6. Patients that have participated in a clinical research study during the last 3 months
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Anticipated start date
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15/07/2010
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Anticipated end date
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15/10/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet
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Target number of participants
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Total sample size is 495 patients from primary health care centres in three Spanish regions
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Interventions
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Patients were randomised to one of three groups, comparing two strategies for the reduction of chronic bendzodizepine and a control group:
1. Structured educational intervention: 1 educational interview (20 - 25 minutes) which addresses some specific aspects of chronic use of benzodiazepines with a pattern of gradual dose reduction of benzodiazepine and 4 - 6 subsequent follow-up visits to control the gradually descending dose
2. Minimal intervention: 1 educational interview (20 - 25 minutes) which addresses some specific aspects of chronic use of benzodiazepines with written information on the pattern of gradually reducing the dosage of benzodiazepine
3. Control group: usual clinical practice, no intervention visits
There will be follow up visits at 6 and 12 months, of 35 minutes duration.
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Primary outcome measure(s)
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Benzodiazepine use at 12 months
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Secondary outcome measure(s)
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1. Anxiety and Depression Scale
2. Quality of Sleep Scale
3. Alcohol consumption
Outcomes will be measured at baseline, 6 and 12 months.
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Sources of funding
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Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
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Trial website
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Publications
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Contact name
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Dr
Catalina
Vicens
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Address
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C/ Matamusinos, 22 (Ponent-Son Serra-La Vileta)
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City/town
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Palma de Mallorca
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Zip/Postcode
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07013
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Country
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Spain
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Email
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Cvicenscaldentey@ibsalut.caib.es
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Sponsor
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Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
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Address
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Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
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City/town
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Palma de Mallorca
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Zip/Postcode
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07003
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Country
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Spain
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Tel
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+34 (0)971 175883
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Fax
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+34 (0)971 175888
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Email
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aleiva@ibsalut.caib.es
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Date applied
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17/06/2010
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Last edited
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27/07/2010
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Date ISRCTN assigned
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27/07/2010
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