Blended Care for the Discontinuation of Benzodiazepine Use
- Conditions
- Benzodiazepine DependenceBenzodiazepine DependentBenzodiazepine Withdrawal
- Interventions
- Behavioral: Blended careBehavioral: Usual care
- Registration Number
- NCT03937180
- Lead Sponsor
- Kristien Coteur
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 924
- Patients aged 18 and older capable of giving informed consent,
- Having his/her Global Medical File managed by one of the participating general practitioners
- Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
- Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems
- Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
- Presence of terminal illness
- Any cases where stopping of (z-)BZDs might be harmful
- Unwillingness or inability to provide informed consent
- Not having e-literacy (being familiar with email and internet use)
- Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blended care Blended 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. Usual care Usual care 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.
- Primary Outcome Measures
Name Time Method Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening 12 months Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
- Secondary Outcome Measures
Name Time Method Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening 6 months Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
EQ-5D-3L assessed at week 6, 12, 26 and 52 12 months 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.
Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52 12 months Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use
The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52 12 months Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed
Trial Locations
- Locations (110)
Fauquert Benjamin
🇧🇪Schaerbeek, Brussel, Belgium
Evrard Antoine
🇧🇪Tilff, Luik, Belgium
Uhry Franck
🇧🇪Uccle, Brussel, Belgium
Vernyns Sander
🇧🇪Hasselt, Limburg, Belgium
Steyaert Elodie
🇧🇪Neupré, Luik, Belgium
Catinus Pierric
🇧🇪Chatelineau, Henegouwen, Belgium
Vanderstraeten Katrien
🇧🇪Berchem, Kluisbergen, Belgium
Ceulemans Steven
🇧🇪Beverst, Limburg, Belgium
Vanschepdael Céline
🇧🇪Saint-Hubert, Luxemburg, Belgium
Deleu Gabriel
🇧🇪Hodeige, Luik, Belgium
Cuelenaere Maarten
🇧🇪Assenede, Oost-Vlaanderen, Belgium
De Sadeleer Jo
🇧🇪Borsbeke, Oost-Vlaanderen, Belgium
Lemlijn Nathalie
🇧🇪Kessel-Lo, Vlaams-Brabant, Belgium
Lens Marie
🇧🇪Ottignies, Waals-Brabant, Belgium
Massaux Godelieve
🇧🇪Wavre, Waals-Brabant, Belgium
Heyerick Maaike
🇧🇪Zulte, Oost-Vlaanderen, Belgium
De Vlieghere Marieke
🇧🇪Jabbeke, West-Vlaanderen, Belgium
Caenepeel Laurens
🇧🇪Koksijde, West-Vlaanderen, Belgium
Delvaux Nicolas
🇧🇪Lissewege, West-Vlaanderen, Belgium
Demeyere Tijs
🇧🇪Moorslede, West-Vlaanderen, Belgium
De Sutter Inge
🇧🇪Aalst, Belgium
Janssen Marie-Eve
🇧🇪Ans, Belgium
Freson Micheline
🇧🇪Damme, Belgium
Vanderbauwhede Stefanie
🇧🇪Kortrijk, Belgium
Van Der Auwera Jolien
🇧🇪Lauwe, Belgium
Grosjean Joël
🇧🇪Mont-sur-Marchienne, Belgium
De Neef Sara
🇧🇪Tienen, Belgium
Maenen Arjen
🇧🇪Alken, Belgium
Maus Katelijne
🇧🇪Antwerpen, Belgium
Balligand Elie
🇧🇪Beringen, Belgium
Van Rossem Inès
🇧🇪Halle, Belgium
Compes Annick
🇧🇪Hannut, Belgium
(Mingneau Jannick) Bourguignon Sofie
🇧🇪Heers, Belgium
Maes Marc
🇧🇪Beverlo, Belgium
Van De Plas Flip
🇧🇪Boechout, Belgium
Van Immerseel Ilke
🇧🇪Hove, Belgium
Staelens Toon
🇧🇪Lauwe, Belgium
Lambert Fabienne
🇧🇪Liège, Belgium
Saintmar Hélène
🇧🇪Marche-en-Famenne, Belgium
Andries Laura
🇧🇪Mortsel, Belgium
Meuris Michel
🇧🇪Spa, Belgium
Pierard Virginie
🇧🇪Monceau-sur-Sambre, Belgium
De Groote Jaron
🇧🇪Oudenaarde, Belgium
Froidcoeur Xavier
🇧🇪Wanze, Belgium
Asselman Valerie
🇧🇪Hoboken, Antwerpen, Belgium
Van Tongelen Sofie
🇧🇪Mechelen, Antwerpen, Belgium
Bedoret Virginie
🇧🇪Woluwe St Pierre, Brussel, Belgium
Leysen Bert
🇧🇪Broechem, Antwerpen, Belgium
Thomas Pol
🇧🇪Jette, Brussel, Belgium
Fransis Jan
🇧🇪Ham, Limburg, Belgium
Maquet Elisabeth
🇧🇪Saint-Gilles, Brussel, Belgium
Vansintejan Johan
🇧🇪Vilvoorde, Brussel, Belgium
Coolen Antoon
🇧🇪Beverst, Limburg, Belgium
Geskens Valérie
🇧🇪Beverst, Limburg, Belgium
Stulens Jan
🇧🇪Hasselt, Limburg, Belgium
Debry Jean-Yves
🇧🇪Ougree, Luik, Belgium
Parada Alberto
🇧🇪Trois-Ponts, Luik, Belgium
Thys Eline
🇧🇪Hasselt, Limburg, Belgium
Beenders Wim
🇧🇪Maaseik, Limburg, Belgium
Vanleeuw Ben
🇧🇪Zolder, Limburg, Belgium
Degrave Stijn
🇧🇪Herzele, Oost-Vlaanderen, Belgium
Andre Jean-François
🇧🇪Liège, Luik, Belgium
Rousseau Cecile
🇧🇪Liège, Luik, Belgium
Lafontaine Jean Baptiste
🇧🇪Namur, Namen, Belgium
Kang Thida
🇧🇪Boncelles, Luik, Belgium
Germay Arlette
🇧🇪Libin, Luxemburg, Belgium
De Vleeschouwer Oriane
🇧🇪Saint-Hubert, Luxemburg, Belgium
Cohnen Ingrid
🇧🇪Waimes, Luik, Belgium
Gueibe France
🇧🇪Libin, Luxemburg, Belgium
Mattart Jacques
🇧🇪Andenne, Namen, Belgium
Mahieu Inge
🇧🇪Asper, Oost-Vlaanderen, Belgium
Van Marcke Maarten
🇧🇪Lebbeke, Oost-Vlaanderen, Belgium
De Muynck Kim
🇧🇪Kaprijke, Oost-Vlaanderen, Belgium
Vermeulen Sofie
🇧🇪Sint-Martens-Latem, Oost-Vlaanderen, Belgium
Vandenameele Steffi
🇧🇪Sijsele, West-Vlaanderen, Belgium
Heijmans Stephane
🇧🇪Linkebeek, Vlaams-Brabant, Belgium
Pening Maud
🇧🇪Nivelles, Waals-Brabant, Belgium
Joos Ellen
🇧🇪Nevele, Oost-Vlaanderen, Belgium
Everaert Leen
🇧🇪Nevele, Oost-Vlaanderen, Belgium
Cramm Myrjam
🇧🇪Antwerpen, Belgium
Wuyts Tinne
🇧🇪Mol, Belgium
Debanterlé Stéphane
🇧🇪Barvaux, Belgium
Bourcy Gaelle
🇧🇪Bastogne, Belgium
Deckers Clementine B
🇧🇪Bastogne, Belgium
Vercruysse Klaas
🇧🇪Berchem, Belgium
Cloetens Hanne
🇧🇪Brugge, Belgium
Haemels Maria-Magdalena
🇧🇪Boortmeerbeek, Belgium
De Wilde Kristien
🇧🇪Beveren, Belgium
Maryssael Mia
🇧🇪Brugge, Belgium
De Meulemeester Marc
🇧🇪Gozée, Belgium
De Walsche Bram
🇧🇪Herentals, Belgium
Muylaert Peter
🇧🇪Merelbeke, Belgium
Steeno Pieter
🇧🇪Putte, Belgium
Lemiengre Marieke
🇧🇪Roeselare, Belgium
Op De Beeck Sabine
🇧🇪Turnhout, Belgium
Devolder Tyrone
🇧🇪Kortrijk, Belgium
Maury Olivier
🇧🇪Linkebeek, Belgium
Heyvaert Goedele
🇧🇪Merchtem, Belgium
Peetermans Luc
🇧🇪Mol, Belgium
Maertens Katrien
🇧🇪Kortrijk, Belgium
Marganne Anneline
🇧🇪Liège, Belgium
Moeremans Paul
🇧🇪Mechelen, Belgium
Cardon Philippe
🇧🇪Sambreville, Belgium
Tilquin Marlene
🇧🇪Wanze, Belgium
Hertegonne Nele
🇧🇪Zottegem, Belgium
Janssen Reinhilde
🇧🇪Watervliet, Belgium
Bayens Kris
🇧🇪Weelde, Belgium
Klaasen Geert
🇧🇪Weelde, Belgium
Kerckvoorde Lien
🇧🇪Aalter, Oost-Vlaanderen, Belgium
Knockaert Iris
🇧🇪Lissewege, West-Vlaanderen, Belgium