An interventional study of Blended care and Usual care in Benzodiazepine Dependence, Benzodiazepine Dependent and Benzodiazepine Withdrawal, sponsored by Kristien Coteur. Completed at 110 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Kristien Coteur · Not applicable, Interventional, and Treatment
This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.
This is the only study on the registry with Kristien Coteur as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive 'usual care' left at the discretion of the treating general practitioner (GP). They are expected to follow the Belgian guidelines, which propose education of the patient about the harmful effects of chronic benzodiazepines and z-drugs ((z-)BZD) use, the alternatives, and the advice to discontinue (z-)BZD use. A stepped approach is recommended. First, a minimal intervention strategy such as a discontinuation letter or a short advice is applied. If unsuccessful, a brief intervention, which may span one or more consults, is recommended. During such an intervention, the GP will - based on the principles of motivational interviewing- assess the patient's readiness for change and match the appropriate intervention. A tapering scheme will be developed which typically consists of a 10-20% reduction in the daily dose of the (z-)BZD every 2-4 weeks.
Behavioral: Usual care
Usual care is supported by the use of an interactive e-tool. The e-tool provides psycho-education about sleep and sleep medication, and exercises featuring cognitive behavioural techniques to enhance the self-management of the patient. It's purpose is to motivate patients to discontinue the use of (z-)BZD, to adapt alternative remedies and to support them in this process. The patient can grant the participating GP access to all his answers in the e-tool, making it possible to discuss their findings and experiences face-to-face. During consultations, the GP will also assess the patients' readiness for change and match the appropriate intervention. A tailored gradual taper of the (z-)BZD will be agreed upon, which typically consists of a 10-20% reduction in the daily dose every 2-4 weeks. Follow-up appointments are scheduled depending on the needs of the patient until the end of dose reduction.
Behavioral: Blended care
An interactive e-learning programme delivered through a secured web-based platform for patients and general practitioners (GPs), blended with face-to-face contacts between the involved GP and patient.
General practitioners offering usual care are expected to follow the Belgian guidelines as described in the most recent online version of "Anxiety, stress and sleeping problems A toolbox for general practitioners." or "Sleeping pills and sedatives. How to assist your patients in the search for other solutions?" which are both available in French and Dutch.
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
Time frame: 12 months
Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening
Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
Time frame: 6 months
EQ-5D-3L assessed at week 6, 12, 26 and 52
Effect of a blended care approach versus usual care on the quality of life. The EQ-5D-3L is the three-level version of the EuroQol five dimension scale measuring quality of life.
Time frame: 12 months
Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52
Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use
Time frame: 12 months
The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52
Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed
Time frame: 12 months
Showing the first 100 of 110 sites.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All individual participant data (IPD) that underlie the results in our publications will be made available upon request. The IPD set will consist of deidentified participant data. It can be obtained by contacting the research team at KU Leuven: PI, catharina.mathei@kuleuven.be; trial coordinator, marc.vannuland@kuleuven.be; project manager, kristien.coteur@kuleuven.be. Each request before September 2023 will be reviewed by the Sponsor. In addition to the IPD set, we will also make the study protocol available through an open access publication, and have registered the trial on clinicaltrials.gov (NCT03937180). The informed consent forms are also publicly available through the trial website (www.bigbirdtrial.com), where the clinical study report will also be disseminated at the end of the trial, after approval of the funder KCE.
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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