Clinical trial on the efficacy of two interventions for discontinuing long term benzodiazepine use in primary care
| ISRCTN | ISRCTN13024375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13024375 |
| Secondary identifying numbers | PS09/00947 |
- Submission date
- 17/06/2010
- Registration date
- 27/07/2010
- Last edited
- 18/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Catalina Vicens
Scientific
Scientific
C/ Matamusinos, 22 (Ponent-Son Serra-La Vileta)
Palma de Mallorca
07013
Spain
| Cvicenscaldentey@ibsalut.caib.es |
Study information
| Study design | Multicentre cluster randomised controlled three-arm parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet |
| 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 |
| Study acronym | BENZORED |
| Study objectives | 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(s) | The Ethics Committee of the Balearic Islands (Comité Ético Investigación Clínica [CEIC])approved on the 29th April 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/07/2010 |
| Completion date | 15/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Total sample size is 495 patients from primary health care centres in three Spanish regions |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/07/2010 |
| Date of final enrolment | 15/10/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/ Matamusinos, 22 (Ponent-Son Serra-La Vileta)
Palma de Mallorca
07013
Spain
07013
Spain
Sponsor information
Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Government
Government
Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
| Phone | +34 (0)971 175883 |
|---|---|
| aleiva@ibsalut.caib.es | |
"ROR" |
https://ror.org/00d9y8h06 |
Funders
Funder type
Government
Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/04/2011 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No |
