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Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines

NCT02127411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2017-05-09

No results posted yet for this study

Summary

Benzodiazepines (BZD) are the most prescribed psychiatric drugs in Brazil, especially for women. Although it is recommended that the use of BZD is not greater than four weeks, there are many cases of prolonged use due to the lack of treatment options for dealing with complaints of insomnia. Given this, the aim of this project is to evaluate the program Mindfulness-Based Relapse Prevention (MBRP) for adult women with chronic use of benzodiazepine (BZD) to induce sleep. Specifically aims to evaluate if the MBRP program, can reduce the pattern of use and level of dependence of chronic users of BZD under gradual reduction (tapering) or cessation of the use of BZD. This study will be conducted at the Drug Dependency Unit (UDED) of the Department of Psychobiology of Federal University of São Paulo. The study will count with two groups: intervention group (IG) and control group (CG) (that will stay in the waitlist until the eighth month . The sample will comprise 100 women with chronic use of BZD as hypnotics, 50 will be randomized in the IG condition and 50 in the CG condition. Changes will be evaluated on several variables such as cessation and dependence of BZD, quality of life, sleep, anxiety, depression and sexual satisfaction before and after the intervention in both groups. The data will be submitted to descriptive and inferential bivariate and multivariate statistic analyzes. It is hoped that this study create subsidies for the development of complementary interventions for the management of withdrawal symptoms in chronic users of BZD.

Conditions

  • Benzodiazepine Dependence

Interventions

BEHAVIORAL

Mindfulness-Based Relapse Prevention

The MBRP is an adjuvant treatment for people that have been treated for drug use related problems

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Ana R Noto, PhD · Affiliate Professor

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127411 on ClinicalTrials.gov