Contact information
Type
Scientific
Primary contact
Dr Catalina Vicens
ORCID ID
Contact details
C/ Matamusinos
22 (Ponent-Son Serra-La Vileta)
Palma de Mallorca
07013
Spain
Cvicenscaldentey@ibsalut.caib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PS09/00947
Study information
Scientific title
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
Acronym
BENZORED
Study hypothesis
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
Ethics approval
The Ethics Committee of the Balearic Islands (Comité Ético Investigación Clínica [CEIC])approved on the 29th April 2009
Study design
Multicentre cluster randomised controlled three-arm parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet
Condition
Benzodiazepine use, reduction and withdrawal
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Benzodiazepine use at 12 months
Secondary outcome measures
1. Anxiety and Depression Scale
2. Quality of Sleep Scale
3. Alcohol consumption
Outcomes will be measured at baseline, 6 and 12 months.
Overall trial start date
15/07/2010
Overall trial end date
15/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total sample size is 495 patients from primary health care centres in three Spanish regions
Participant exclusion criteria
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
Recruitment start date
15/07/2010
Recruitment end date
15/10/2012
Locations
Countries of recruitment
Spain
Trial participating centre
C/ Matamusinos, 22 (Ponent-Son Serra-La Vileta)
Palma de Mallorca
07013
Spain
Sponsor information
Organisation
Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Sponsor details
Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
+34 (0)971 175883
aleiva@ibsalut.caib.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21507257
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24526745
Publication citations
-
Protocol
Vicens C, Socias I, Mateu C, Leiva A, Bejarano F, Sempere E, Basora J, Palop V, Mengual M, Beltran JL, Aragonès E, Lera G, Folch S, Piñol JL, Esteva M, Roca M, Arenas A, Del Mar Sureda M, Campoamor F, Fiol F, Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: a protocol for a clustered, randomized clinical trial., BMC Fam Pract, 2011, 12, 23, doi: 10.1186/1471-2296-12-23.
-
Results
Vicens C, Bejarano F, Sempere E, Mateu C, Fiol F, Socias I, Aragonès E, Palop V, Beltran JL, Piñol JL, Lera G, Folch S, Mengual M, Basora J, Esteva M, Llobera J, Roca M, Gili M, Leiva A, Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care., Br J Psychiatry, 2014, 204, 6, 471-479, doi: 10.1192/bjp.bp.113.134650.