Nepsis - Research Center on Health and Substance Use - MBRP Brasil - Brazilian Center of Research and Training on Mindfulness-Based Relapse Prevention -Departamento de Psicobiologia, Universidade Federal de São Paulo Rua Botucatu, 862, 1st floor, Vila Clementino, 04,023-062, Sao Paulo, SP, Brazil.
Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Departmento de Medicina Preventiva Universidade Federal de São Paulo Avenida Padre José Maria, 545, Santo Amaro, 04,753-060, Sao Paulo, SP, Brazil.
Int J Behav Med. 2022 Jun;29(3):266-277. doi: 10.1007/s12529-021-10002-4. Epub 2021 May 19.
Hypnotics are one of the most frequently prescribed drugs worldwide, especially for women, and their chronic use may lead to tolerance, dosage escalation, dependence, withdrawal syndrome, and cognitive impairments, representing a significant public health problem. Consistent evidence from previous studies shows benefits of mindfulness-based interventions (MBIs) for substance use disorders (SUD) and insomnia. However, to date, there is a lack of research about effects of MBIs on reduction/cessation of chronic hypnotic use among women with insomnia.
The present randomized trial evaluated the efficacy of the 8-week group-delivered mindfulness-based relapse prevention (MBRP) program in an intervention group (IG, n = 34) compared with weekly phone monitoring only in the control group (CG, n = 36) in reducing hypnotic use and insomnia severity over a 6-month follow-up period.
There were significant differences between groups at baseline regarding hypnotic use but not insomnia. Group effects on hypnotic use were found immediately after the intervention (bT1 = 2.01, p < 0.001) and at the 2-month follow-up (bT2 = 2.21, p < 0.001), favoring the IG. The IG also had a greater reduction from baseline levels than the control group in insomnia severity at the 4-month (bT3 = 0.21, p = 0.045) and 6-month (bT4 = 0.32, p = 0.002) follow-ups.
The findings provide preliminary evidence of benefits of MBRP for reducing insomnia severity and potentially chronic hypnotic use. However, IG effects on chronic hypnotic use may have resulted from IG and control group differences in chronic hypnotic use at baseline.
ClinicalTrials.gov Identifier: NCT02127411.
催眠药是全球范围内使用最广泛的药物之一，尤其是在女性中，长期使用可能导致耐受、剂量增加、依赖、戒断综合征和认知障碍，这是一个重大的公共卫生问题。先前的研究一致表明，基于正念的干预措施（MBIs）对物质使用障碍（SUD）和失眠症有一定的疗效。然而，迄今为止，关于 MBI 对减少/停止失眠症女性慢性催眠药使用的效果，还缺乏相关研究。
本随机试验评估了 8 周团体正念预防复吸（MBRP）方案在干预组（IG，n=34）中的疗效，与对照组（CG，n=36）每周仅通过电话监测相比，在 6 个月的随访期间，观察 MBRP 方案对减少催眠药使用和失眠严重程度的影响。
两组在催眠药使用方面存在显著差异，但在失眠方面无显著差异。干预后即刻（bT1=2.01，p<0.001）和 2 个月随访时（bT2=2.21，p<0.001），组间差异显著，IG 组催眠药使用减少更明显。IG 组在 4 个月（bT3=0.21，p=0.045）和 6 个月（bT4=0.32，p=0.002）随访时的失眠严重程度也比对照组有更大的降低。
研究结果初步证明了 MBRP 对减轻失眠严重程度和潜在的慢性催眠药使用的有效性。然而，IG 组在慢性催眠药使用方面的效果可能是由于 IG 组和对照组在基线时慢性催眠药使用存在差异。
ClinicalTrials.gov 标识符：NCT02127411。
