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Benzodiazepine DependenceMBRPNCT02127411

Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines

A study testing Mindfulness-Based Relapse Prevention in people with Benzodiazepine Dependence, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Benzodiazepine Dependence
What is being tested?
Mindfulness-Based Relapse Prevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteBrazil
Study dates
Oct 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Drug Dependency Unit of the Universidade Federal de São Paulo (UDED)

    São Paulo, São Paulo

Other trials in Brazil

About this study

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

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.

Being tested
Mindfulness-Based Relapse Prevention
Keywords
Mindfulness, Benzodiazepines, Sleep, Dependence, Relapse Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Relapse PreventionBehavioural

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

Study groups in NCT02127411
Study groupRoleWhat they receive
Mindfulness-based relapse preventionExperimentalMindfulness-Based Relapse Prevention
Receives: Behavioral: Mindfulness-Based Relapse Prevention
WaitlistNo interventionthis group will stay in the waitlist until the end of follow-up assessments, when they will receive the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline in benzodiazepine use at 8 months.

  2. 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.

    Measured: Change from baseline in insomnia severity at 8 months

Secondary outcomes (10)

  1. 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"

    Measured: Change from Baseline of the stage of change at 8 months

  2. 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

    Measured: Change in mindfulness level from baseline at 8 months

  3. 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.

    Measured: change in benzodiazepine dependence severity from baseline at 8 months

  4. 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.

    Measured: Change in symptoms of depression from baseline at 8 months

  5. Sleep Quality

    will be measured through the Pittsburgh Sleep Quality Index

    Measured: Change in sleep quality from baseline at 8 months

  6. menopausal symptoms (Kupperman index)

    Measured: change in menopausal symptoms from baseline at 8 months

  7. Female Sexual Satisfaction

    Measured: change in female sexual satisfaction from baseline at 8 months

  8. presence of benzodiazepines metabolites identified with a toxicology urinalysis

    Measured: Change in benzodiazepine metabolites from baseline at eight months

  9. 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

    Measured: Baseline and 2 month follow-up

  10. Trait Anxiety

    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.

    Measured: Baseline, 2, 4 6 and 8 months follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02127411
Sponsor's protocol ID
MBRP BZD
Other IDs
CNPq and Fapesp
Acronym
MBRP
Status last verified
May 2017
First submitted
10 Mar 2014
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34013489

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Relapse Prevention in people with Benzodiazepine Dependence, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reduction of benzodiazepine use (time frame: Change from baseline in benzodiazepine use at 8 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02127411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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