AzTrials
AzTrials

Benzodiazepine DependenceBig BirdNCT03937180

Blended Care for the Discontinuation of Benzodiazepine Use

A study testing Blended care in people with Benzodiazepine Dependence and Benzodiazepine Dependent, run by Kristien Coteur at 110 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blended care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
924 participants
Where
110 sitesBelgium
Study dates
24 Jun 2019to 2 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

110 sites in 1 country.

110 sites in 1 country

Belgium110 sites

  • De Sutter Inge

    Aalst

  • Kerckvoorde Lien

    Aalter, Oost-Vlaanderen, 9880

  • Maenen Arjen

    Alken

  • Mattart Jacques

    Andenne, Namen, 5300

  • Janssen Marie-Eve

    Ans

  • Cramm Myrjam

    Antwerp, 2000

  • Maus Katelijne

    Antwerp

  • Mahieu Inge

    Asper, Oost-Vlaanderen, 9890

  • Cuelenaere Maarten

    Assenede, Oost-Vlaanderen, 9960

  • Debanterlé Stéphane

    Barvaux, 6940

  • Bourcy Gaelle

    Bastogne

  • Deckers Clementine B

    Bastogne

  • Vanderstraeten Katrien

    Berchem, Kluisbergen

  • Vercruysse Klaas

    Berchem, 9690

  • Balligand Elie

    Beringen

  • De Wilde Kristien

    Beveren

  • Maes Marc

    Beverlo

  • Ceulemans Steven

    Beverst, Limburg, 3740

  • Coolen Antoon

    Beverst, Limburg, 3740

  • Geskens Valérie

    Beverst, Limburg, 3740

  • Van De Plas Flip

    Boechout, 2530

  • Kang Thida

    Boncelles, Luik, 4100

  • Haemels Maria-Magdalena

    Boortmeerbeek

  • De Sadeleer Jo

    Borsbeke, Oost-Vlaanderen, 9552

  • Leysen Bert

    Broechem, Antwerpen, 2520

  • Cloetens Hanne

    Bruges

  • Maryssael Mia

    Bruges

  • Catinus Pierric

    Châtelineau, Henegouwen, 6200

  • Freson Micheline

    Damme

  • De Meulemeester Marc

    Gozée

  • Van Rossem Inès

    Halle

  • Fransis Jan

    Ham, Limburg, 3945

  • Compes Annick

    Hannut

  • Stulens Jan

    Hasselt, Limburg, 3500

  • Thys Eline

    Hasselt, Limburg, 3500

  • Vernyns Sander

    Hasselt, Limburg, 3510

  • (Mingneau Jannick) Bourguignon Sofie

    Heers

  • De Walsche Bram

    Herentals

  • Degrave Stijn

    Herzele, Oost-Vlaanderen, 9550

  • Asselman Valerie

    Hoboken, Antwerpen, 2660

  • Deleu Gabriel

    Hodeige, Luik, 4351

  • Van Immerseel Ilke

    Hove

  • De Vlieghere Marieke

    Jabbeke, West-Vlaanderen, 8490

  • Thomas Pol

    Jette, Brussels Capital, 1090

  • De Muynck Kim

    Kaprijke, Oost-Vlaanderen, 9970

  • Lemlijn Nathalie

    Kessel-Lo, Vlaams-Brabant, 3010

  • Caenepeel Laurens

    Koksijde, West-Vlaanderen, 8670

  • Devolder Tyrone

    Kortrijk

  • Maertens Katrien

    Kortrijk

  • Vanderbauwhede Stefanie

    Kortrijk

  • Staelens Toon

    Lauwe

  • Van Der Auwera Jolien

    Lauwe

  • Van Marcke Maarten

    Lebbeke, Oost-Vlaanderen, 9280

  • Germay Arlette

    Libin, Luxemburg, 6890

  • Gueibe France

    Libin, Luxemburg, 6890

  • Andre Jean-François

    Liège, Luik, 4000

  • Rousseau Cecile

    Liège, Luik, 4020

  • Marganne Anneline

    Liège, 4000

  • Lambert Fabienne

    Liège

  • Heijmans Stephane

    Linkebeek, Vlaams-Brabant, 1630

  • Maury Olivier

    Linkebeek

  • Delvaux Nicolas

    Lissewege, West-Vlaanderen, 8380

  • Knockaert Iris

    Lissewege, West-Vlaanderen, 8380

  • Beenders Wim

    Maaseik, Limburg, 3680

  • Saintmar Hélène

    Marche-en-Famenne

  • Van Tongelen Sofie

    Mechelen, Antwerpen, 2800

  • Moeremans Paul

    Mechelen

  • Heyvaert Goedele

    Merchtem, 1785

  • Muylaert Peter

    Merelbeke, 9820

  • Peetermans Luc

    Mol

  • Wuyts Tinne

    Mol

  • Pierard Virginie

    Monceau-sur-Sambre

  • Grosjean Joël

    Mont-sur-Marchienne

  • Demeyere Tijs

    Moorslede, West-Vlaanderen, 8890

  • Andries Laura

    Mortsel

  • Lafontaine Jean Baptiste

    Namur, Namen, 5000

  • Steyaert Elodie

    Neupré, Luik, 4120

  • Joos Ellen

    Nevele, Oost-Vlaanderen, 9580

  • Everaert Leen

    Nevele, Oost-Vlaanderen, 9850

  • Pening Maud

    Nivelles, Waals-Brabant, 1400

  • Lens Marie

    Ottignies, Waals-Brabant, 1340

  • De Groote Jaron

    Oudenaarde

  • Debry Jean-Yves

    Ougrée, Luik, 4102

  • Steeno Pieter

    Putte

  • Lemiengre Marieke

    Roeselare

  • Maquet Elisabeth

    Saint-Gilles, Brussels Capital, 1060

  • De Vleeschouwer Oriane

    Saint-Hubert, Luxemburg, 6870

  • Vanschepdael Céline

    Saint-Hubert, Luxemburg, 6870

  • Cardon Philippe

    Sambreville, 5060

  • Fauquert Benjamin

    Schaarbeek, Brussels Capital, 1030

  • Vandenameele Steffi

    Sijsele, West-Vlaanderen, 8340

  • Vermeulen Sofie

    Sint-Martens-Latem, Oost-Vlaanderen, 9830

  • Meuris Michel

    Spa

  • De Neef Sara

    Tienen

  • Evrard Antoine

    Tilff, Luik, 4130

  • Parada Alberto

    Trois-Ponts, Luik, 4980

  • Op De Beeck Sabine

    Turnhout, 2300

  • Uhry Franck

    Uccle, Brussels Capital, 1180

  • Vansintejan Johan

    Vilvoorde, Brussels Capital, 1800

  • Cohnen Ingrid

    Waimes, Luik, 4950

  • Froidcoeur Xavier

    Wanze

  • Tilquin Marlene

    Wanze

  • Janssen Reinhilde

    Watervliet

  • Massaux Godelieve

    Wavre, Waals-Brabant, 1300

  • Bayens Kris

    Weelde

  • Klaasen Geert

    Weelde

  • Bedoret Virginie

    Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, 1150

  • Vanleeuw Ben

    Zolder, Limburg, 3350

  • Hertegonne Nele

    Zottegem

  • Heyerick Maaike

    Zulte, Oost-Vlaanderen, 9870

Other trials in Belgium

About this study

Official title: The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.

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.

Being tested
Blended care, Usual care
Keywords
benzodiazepines, blended care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blended careBehavioural

    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.

  • Usual careBehavioural

    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.

Study groups in NCT03937180
Study groupRoleWhat they receive
Usual careOtherPatients 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.
Receives: Behavioral: Usual care
Blended careExperimentalUsual 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.
Receives: Behavioral: Blended care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (4)

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start24 Jun 2019
  3. Primary completion30 Jul 2021
  4. Study completion2 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster randomized controlled trial
Masking
None (open label)
Enrolment
924 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937180
Sponsor's protocol ID
S61194
Other IDs
KCE-17016
Acronym
Big Bird
Status last verified
Jul 2022
First submitted
2 May 2019
Last updated
15 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 37027198

  • 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.

    PubMed 36413221

  • 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.

    PubMed 32075832

Questions about this trial

What is this clinical trial studying?

A study testing Blended care in people with Benzodiazepine Dependence and Benzodiazepine Dependent, run by Kristien Coteur at 110 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937180, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in