Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines

NCT02127411 | Completed

• 2 other identifiers: MBRP BZDCNPq and Fapesp
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Dependence

Keywords

Mindfulness; Benzodiazepines; Sleep; Dependence; Relapse Prevention

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (10)

• Stage of change related to benzodiazepine use

  Change from Baseline of the stage of change at 8 months

• self report mindfulness level

  Change in mindfulness level from baseline at 8 months

• Level of Benzodiazepine dependence (from mild to severe)

  change in benzodiazepine dependence severity from baseline at 8 months

• Symptoms of depression

  Change in symptoms of depression from baseline at 8 months

• Sleep Quality

  Change in sleep quality from baseline at 8 months

Study Arms (2)

Mindfulness-based relapse prevention

EXPERIMENTAL

Mindfulness-Based Relapse Prevention

Behavioral: Mindfulness-Based Relapse Prevention

Waitlist

NO INTERVENTION

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

Interventions

Mindfulness-Based Relapse Prevention BEHAVIORAL

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

Mindfulness-based relapse prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34013489 DERIVED

Study Officials

• Ana R Noto, PhD

  Affiliate Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor at the Psychobiology Department

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: April 30, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

BR (1)