Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines (MBRP)

Federal University of São Paulo

Status

Completed

Conditions

Benzodiazepine Dependence

Treatments

Behavioral: Mindfulness-Based Relapse Prevention

Study type

Interventional

Funder types

Other

Identifiers

NCT02127411

CNPq and Fapesp (Other Grant/Funding Number)

MBRP BZD

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Literate adult women
Using benzodiazepine (BZD) for inducing sleep for at least 03 months (90 days), for at least four times a week.

Exclusion criteria

Having practiced regularly meditation, yoga or similar previously, at least once a week, for at least three months, or have carried this practice regularly at least once a week in the last year for at least one month
Neurological disorders, anxiety refractory to other treatments or insomnia secondary to other severe clinical conditions, which the BZD withdrawal is considered as a potential risk for worsening
Presence of not controlled clinical disease or of greater severity, such as cancer, schizophrenia, epilepsy
Presence of psychiatric illness which withdrawal of BZD is considered a potential risk for worsening
Dependence or abuse of alcohol or other drugs, except tobacco
In acute treatment for psychological or psychiatric problems
Be participating in a tapering BZD protocol, or similar