Clinical trial NCT02127411: Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines
Official title: Adaptation and Evaluation of the Mindfulness-Based Relapse Prevention Program for Cessation and/or Reduction of Benzodiazepine Chronic Use to Induce Sleep Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benzodiazepine Dependence
Keywords: Mindfulness
Benzodiazepines
Sleep
Dependence
Relapse Prevention
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-04-30
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: reduction of benzodiazepine use
timeFrame: Change from baseline in benzodiazepine use at 8 months.
measure: Severity of insomnia
timeFrame: Change from baseline in insomnia severity at 8 months
Secondary outcomes:
measure: Stage of change related to benzodiazepine use
timeFrame: Change from Baseline of the stage of change at 8 months
measure: self report mindfulness level
timeFrame: Change in mindfulness level from baseline at 8 months
measure: Level of Benzodiazepine dependence (from mild to severe)
timeFrame: change in benzodiazepine dependence severity from baseline at 8 months
measure: Symptoms of depression
timeFrame: Change in symptoms of depression from baseline at 8 months
measure: Sleep Quality
timeFrame: Change in sleep quality from baseline at 8 months
measure: menopausal symptoms (Kupperman index)
timeFrame: change in menopausal symptoms from baseline at 8 months
measure: Female Sexual Satisfaction
timeFrame: change in female sexual satisfaction from baseline at 8 months
measure: presence of benzodiazepines metabolites identified with a toxicology urinalysis
timeFrame: Change in benzodiazepine metabolites from baseline at eight months
measure: Epigenetic modifications
timeFrame: Baseline and 2 month follow-up
measure: Trait Anxiety
timeFrame: Baseline, 2, 4 6 and 8 months follow-ups
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Drug Dependency Unit of the Universidade Federal de São Paulo (UDED)
state: SP
Study officials:
affiliation: Affiliate Professor
name: Ana R Noto, PhD
role: STUDY_CHAIR
References:
citation: Barros VV, Opaleye ES, Demarzo M, Curado DF, Bowen S, Hachul H, Noto AR. Effects of Mindfulness-Based Relapse Prevention on the Chronic use of Hypnotics in Treatment-Seeking Women with Insomnia: a Randomized Controlled Trial. Int J Behav Med. 2022 Jun;29(3):266-277. doi: 10.1007/s12529-021-10002-4. Epub 2021 May 19.