MBRP: Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02127411

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benzodiazepine Dependence	Behavioral: Mindfulness-Based Relapse Prevention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness-based relapse prevention Mindfulness-Based Relapse Prevention	Behavioral: Mindfulness-Based Relapse Prevention The MBRP is an adjuvant treatment for people that have been treated for drug use related problems
No Intervention: Waitlist this group will stay in the waitlist until the end of follow-up assessments, when they will receive the intervention

Arm

Intervention/Treatment

Experimental: Mindfulness-based relapse prevention

Mindfulness-Based Relapse Prevention

Behavioral: Mindfulness-Based Relapse Prevention

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

No Intervention: Waitlist

this group will stay in the waitlist until the end of follow-up assessments, when they will receive the intervention

Outcome Measures

Primary Outcome Measures

reduction of benzodiazepine use [Change from baseline in benzodiazepine use at 8 months.]
We will evaluate the reduction through a percentual comparison between the dose the patient is using at follow-up assessments and the dose related at the beginning of the study.
Severity of insomnia [Change from baseline in insomnia severity at 8 months]
We will evluate the severity os insomnia with the Insomnia Severity Index (ISI) which is a self-report questionnaire and consists of seven items that evaluate severity of sleep onset, sleep maintenance and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others, and distress caused by sleep difficulties. The score for each item ranges from 0 to 4, totaling 0 to 28 points, with a higher score indicating greater insomnia severity.

Secondary Outcome Measures

Stage of change related to benzodiazepine use [Change from Baseline of the stage of change at 8 months]
This will be measured by an analogic rule from 1 to 10, in which 1 means "not ready to change" and 10 means "actively working in the change"
self report mindfulness level [Change in mindfulness level from baseline at 8 months]
This will be measured with the self report questionnaires: Five Facet Mindfulness Questionnaire. This is a self-report questionnaire and do not have a specific metric to measure mindfulness. The scores are absolute and a higher score denotes higher levels of mindfulness
Level of Benzodiazepine dependence (from mild to severe) [change in benzodiazepine dependence severity from baseline at 8 months]
this will be measured through the Benzodiazepine Dependence Self-Report Questionnaire, which is a self report questionnaire and do not provides a specific metric to measure the severity of dependence.
Symptoms of depression [Change in symptoms of depression from baseline at 8 months]
The symptoms of depression will be measured through the Center for Epidemiologic Studies Depression Scale - CES-D. As it is a self report scale, there is no specific metric to measure depression.
Sleep Quality [Change in sleep quality from baseline at 8 months]
will be measured through the Pittsburgh Sleep Quality Index
menopausal symptoms (Kupperman index) [change in menopausal symptoms from baseline at 8 months]
Female Sexual Satisfaction [change in female sexual satisfaction from baseline at 8 months]
presence of benzodiazepines metabolites identified with a toxicology urinalysis [Change in benzodiazepine metabolites from baseline at eight months]
Epigenetic modifications [Baseline and 2 month follow-up]
Blood collection will be held, and the plasma will be analyzed to evaluate levels of homocysteine and cysteine , two aminoacids that are related to epigenetic modifications that can modulate the behavioral responses resulting from the practice of meditation
Trait Anxiety [Baseline, 2, 4 6 and 8 months follow-ups]
Evaluated using the State and Trait Anxiety Index (STAI), validated in Brazil (α = 0.87). We used only the subscale of trait anxiety, less susceptible to environmental alterations. This subscale is composed by 20 items on a four-point Likert scale ("almost never", "sometimes", "often", "almost always"), in which the participant is instructed to answer "how do you usually feel". The Cronbach α in this sample was 0.90.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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