Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines

Benzodiazepine Dependence Clinical Trial

— MBRP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127411
• Other study ID #: MBRP BZD
• Secondary ID: CNPq and Fapesp
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: May 8, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benzodiazepine Dependence
• Recurrence

Intervention

Behavioral:
• Mindfulness-Based Relapse Prevention
The MBRP is an adjuvant treatment for people that have been treated for drug use related problems

Locations

Country	Name	City	State
Brazil	Drug Dependency Unit of the Universidade Federal de São Paulo (UDED)	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of benzodiazepine use	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.	Change from baseline in benzodiazepine use at 8 months.
Primary	Severity of insomnia	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.	Change from baseline in insomnia severity at 8 months
Secondary	Stage of change related to benzodiazepine use	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"	Change from Baseline of the stage of change at 8 months
Secondary	self report mindfulness level	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	Change in mindfulness level from baseline at 8 months
Secondary	Level of Benzodiazepine dependence (from mild to severe)	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.	change in benzodiazepine dependence severity from baseline at 8 months
Secondary	Symptoms of depression	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.	Change in symptoms of depression from baseline at 8 months
Secondary	Sleep Quality	will be measured through the Pittsburgh Sleep Quality Index	Change in sleep quality from baseline at 8 months
Secondary	menopausal symptoms (Kupperman index)		change in menopausal symptoms from baseline at 8 months
Secondary	Female Sexual Satisfaction		change in female sexual satisfaction from baseline at 8 months
Secondary	presence of benzodiazepines metabolites identified with a toxicology urinalysis		Change in benzodiazepine metabolites from baseline at eight months
Secondary	Epigenetic modifications	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	Baseline and 2 month follow-up
Secondary	Trait Anxiety	Evaluated using the State and Trait Anxiety Index (STAI), validated in Brazil (a = 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 a in this sample was 0.90.	Baseline, 2, 4 6 and 8 months follow-ups