Blended Care for the Discontinuation of Benzodiazepine Use

NCT ID: NCT03937180

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 924 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2021-08-02

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.

Conditions

Benzodiazepine Dependence; Benzodiazepine Dependent; Benzodiazepine Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Usual care

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Blended care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belgium Health Care Knowledge Centre

OTHER_GOV

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Université de Liège

OTHER

Sponsor Role: collaborator

Kristien Coteur

OTHER

Sponsor Role: lead

Responsible Party

Kristien Coteur

Project manager - p.p. Chief investigator prof. dr. Catharina Matheï

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Catharina Matheï

Role: STUDY_CHAIR

KU Leuven

Locations

Leysen Bert

Broechem, Antwerpen, Belgium

Asselman Valerie

Hoboken, Antwerpen, Belgium

Van Tongelen Sofie

Mechelen, Antwerpen, Belgium

Thomas Pol

Jette, Brussels Capital, Belgium

Maquet Elisabeth

Saint-Gilles, Brussels Capital, Belgium

Fauquert Benjamin

Schaarbeek, Brussels Capital, Belgium

Uhry Franck

Uccle, Brussels Capital, Belgium

Vansintejan Johan

Vilvoorde, Brussels Capital, Belgium

Bedoret Virginie

Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, Belgium

Catinus Pierric

Châtelineau, Henegouwen, Belgium

Vanderstraeten Katrien

Berchem, Kluisbergen, Belgium

Ceulemans Steven

Beverst, Limburg, Belgium

Coolen Antoon

Beverst, Limburg, Belgium

Geskens Valérie

Beverst, Limburg, Belgium

Fransis Jan

Ham, Limburg, Belgium

Stulens Jan

Hasselt, Limburg, Belgium

Thys Eline

Hasselt, Limburg, Belgium

Vernyns Sander

Hasselt, Limburg, Belgium

Beenders Wim

Maaseik, Limburg, Belgium

Vanleeuw Ben

Zolder, Limburg, Belgium

Kang Thida

Boncelles, Luik, Belgium

Deleu Gabriel

Hodeige, Luik, Belgium

Andre Jean-François

Liège, Luik, Belgium

Rousseau Cecile

Liège, Luik, Belgium

Steyaert Elodie

Neupré, Luik, Belgium

Debry Jean-Yves

Ougrée, Luik, Belgium

Evrard Antoine

Tilff, Luik, Belgium

Parada Alberto

Trois-Ponts, Luik, Belgium

Cohnen Ingrid

Waimes, Luik, Belgium

Germay Arlette

Libin, Luxemburg, Belgium

Gueibe France

Libin, Luxemburg, Belgium

De Vleeschouwer Oriane

Saint-Hubert, Luxemburg, Belgium

Vanschepdael Céline

Saint-Hubert, Luxemburg, Belgium

Mattart Jacques

Andenne, Namen, Belgium

Lafontaine Jean Baptiste

Namur, Namen, Belgium

Kerckvoorde Lien

Aalter, Oost-Vlaanderen, Belgium

Mahieu Inge

Asper, Oost-Vlaanderen, Belgium

Cuelenaere Maarten

Assenede, Oost-Vlaanderen, Belgium

De Sadeleer Jo

Borsbeke, Oost-Vlaanderen, Belgium

Degrave Stijn

Herzele, Oost-Vlaanderen, Belgium

De Muynck Kim

Kaprijke, Oost-Vlaanderen, Belgium

Van Marcke Maarten

Lebbeke, Oost-Vlaanderen, Belgium

Joos Ellen

Nevele, Oost-Vlaanderen, Belgium

Everaert Leen

Nevele, Oost-Vlaanderen, Belgium

Vermeulen Sofie

Sint-Martens-Latem, Oost-Vlaanderen, Belgium

Heyerick Maaike

Zulte, Oost-Vlaanderen, Belgium

Lemlijn Nathalie

Kessel-Lo, Vlaams-Brabant, Belgium

Heijmans Stephane

Linkebeek, Vlaams-Brabant, Belgium

Pening Maud

Nivelles, Waals-Brabant, Belgium

Lens Marie

Ottignies, Waals-Brabant, Belgium

Massaux Godelieve

Wavre, Waals-Brabant, Belgium

De Vlieghere Marieke

Jabbeke, West-Vlaanderen, Belgium

Caenepeel Laurens

Koksijde, West-Vlaanderen, Belgium

Delvaux Nicolas

Lissewege, West-Vlaanderen, Belgium

Knockaert Iris

Lissewege, West-Vlaanderen, Belgium

Demeyere Tijs

Moorslede, West-Vlaanderen, Belgium

Vandenameele Steffi

Sijsele, West-Vlaanderen, Belgium

De Sutter Inge

Aalst, , Belgium

Maenen Arjen

Alken, , Belgium

Janssen Marie-Eve

Ans, , Belgium

Cramm Myrjam

Antwerp, , Belgium

Maus Katelijne

Antwerp, , Belgium

Debanterlé Stéphane

Barvaux, , Belgium

Bourcy Gaelle

Bastogne, , Belgium

Deckers Clementine B

Bastogne, , Belgium

Vercruysse Klaas

Berchem, , Belgium

Balligand Elie

Beringen, , Belgium

De Wilde Kristien

Beveren, , Belgium

Maes Marc

Beverlo, , Belgium

Van De Plas Flip

Boechout, , Belgium

Haemels Maria-Magdalena

Boortmeerbeek, , Belgium

Cloetens Hanne

Bruges, , Belgium

Maryssael Mia

Bruges, , Belgium

Freson Micheline

Damme, , Belgium

De Meulemeester Marc

Gozée, , Belgium

Van Rossem Inès

Halle, , Belgium

Compes Annick

Hannut, , Belgium

(Mingneau Jannick) Bourguignon Sofie

Heers, , Belgium

De Walsche Bram

Herentals, , Belgium

Van Immerseel Ilke

Hove, , Belgium

Devolder Tyrone

Kortrijk, , Belgium

Maertens Katrien

Kortrijk, , Belgium

Vanderbauwhede Stefanie

Kortrijk, , Belgium

Staelens Toon

Lauwe, , Belgium

Van Der Auwera Jolien

Lauwe, , Belgium

Marganne Anneline

Liège, , Belgium

Lambert Fabienne

Liège, , Belgium

Maury Olivier

Linkebeek, , Belgium

Saintmar Hélène

Marche-en-Famenne, , Belgium

Moeremans Paul

Mechelen, , Belgium

Heyvaert Goedele

Merchtem, , Belgium

Muylaert Peter

Merelbeke, , Belgium

Peetermans Luc

Mol, , Belgium

Wuyts Tinne

Mol, , Belgium

Pierard Virginie

Monceau-sur-Sambre, , Belgium

Grosjean Joël

Mont-sur-Marchienne, , Belgium

Andries Laura

Mortsel, , Belgium

De Groote Jaron

Oudenaarde, , Belgium

Steeno Pieter

Putte, , Belgium

Lemiengre Marieke

Roeselare, , Belgium

Cardon Philippe

Sambreville, , Belgium

Meuris Michel

Spa, , Belgium

De Neef Sara

Tienen, , Belgium

Op De Beeck Sabine

Turnhout, , Belgium

Froidcoeur Xavier

Wanze, , Belgium

Tilquin Marlene

Wanze, , Belgium

Janssen Reinhilde

Watervliet, , Belgium

Bayens Kris

Weelde, , Belgium

Klaasen Geert

Weelde, , Belgium

Hertegonne Nele

Zottegem, , Belgium

Countries

Belgium

References

Coteur K, Van Nuland M, Schoenmakers B, Anthierens S, Van den Broeck K. Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Apr 7;7:e43738. doi: 10.2196/43738.

Reference Type: DERIVED

PMID: 37027198 (View on PubMed)

Coteur K, Henrard G, Schoenmakers B, Laenen A, Van den Broeck K, De Sutter A, Anthierens S, Devroey D, Kacenelenbogen N, Offermans AM, Van Nuland M. Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care. Sleep. 2023 Apr 12;46(4):zsac278. doi: 10.1093/sleep/zsac278.

Reference Type: DERIVED

PMID: 36413221 (View on PubMed)

Coteur K, Van Nuland M, Vanmeerbeek M, Henrard G, Anthierens S, Van den Broeck K, De Sutter A, Creupelandt H, Devroey D, Van Overmeire R, Offermans AM, Kacenelenbogen N, Laenen A, Mathei C. Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial. BMJ Open. 2020 Feb 18;10(2):e033688. doi: 10.1136/bmjopen-2019-033688.

Reference Type: DERIVED

PMID: 32075832 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KCE-17016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S61194

Identifier Type: -

Identifier Source: org_study_id