Blended Care for the Discontinuation of Benzodiazepine Use

Not Applicable

Completed

• Conditions: Benzodiazepine Dependence; Benzodiazepine Dependent; Benzodiazepine Withdrawal

• 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

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-06-24
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 924

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Leysen Bert; 🇧🇪 Broechem, Antwerpen, Belgium

Asselman Valerie; 🇧🇪 Hoboken, Antwerpen, Belgium

Van Tongelen Sofie; 🇧🇪 Mechelen, Antwerpen, Belgium

Thomas Pol; 🇧🇪 Jette, Brussel, Belgium

Maquet Elisabeth; 🇧🇪 Saint-Gilles, Brussel, Belgium

Fauquert Benjamin; 🇧🇪 Schaerbeek, Brussel, Belgium

Uhry Franck; 🇧🇪 Uccle, Brussel, Belgium

Vansintejan Johan; 🇧🇪 Vilvoorde, Brussel, Belgium

Bedoret Virginie; 🇧🇪 Woluwe St Pierre, Brussel, Belgium

Catinus Pierric; 🇧🇪 Chatelineau, Henegouwen, Belgium

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