Adaptation and Evaluation of the Mindfulness-Based Relapse Prevention Program for Cessation and/or Reduction of Benzodiazepine Chronic Use to Induce Sleep Among Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Severity of insomnia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Literate adult women
- •Using benzodiazepine (BZD) for inducing sleep for at least 03 months (90 days), for at least four times a week.
排除标准
- •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
结局指标
主要结局
Severity of insomnia
时间窗: 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.
reduction of benzodiazepine use
时间窗: 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.
次要结局
- menopausal symptoms (Kupperman index)(change in menopausal symptoms from baseline at 8 months)
- self report mindfulness level(Change in mindfulness level from baseline at 8 months)
- Sleep Quality(Change in sleep quality from baseline at 8 months)
- Epigenetic modifications(Baseline and 2 month follow-up)
- Stage of change related to benzodiazepine use(Change from Baseline of the stage of change at 8 months)
- Symptoms of depression(Change in symptoms of depression 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)
- Level of Benzodiazepine dependence (from mild to severe)(change in benzodiazepine dependence severity from baseline at 8 months)
- Trait Anxiety(Baseline, 2, 4 6 and 8 months follow-ups)
研究者
Ana Regina Noto
Adjunct Professor at the Psychobiology Department
Federal University of São Paulo