Condition category
Mental and Behavioural Disorders
Date applied
17/06/2010
Date assigned
27/07/2010
Last edited
18/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes