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促进双相情感障碍患者的药物依从性:一项多中心随机对照试验的多方面干预。

Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention.

机构信息

Social Determinants of Health Research Center,Qazvin University of Medical Sciences,Qazvin,Iran.

Department of Psychiatry,Icahn School of Medicine at Mount Sinai,New York, NY,USA.

出版信息

Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27.

DOI:10.1017/S003329171700109X
PMID:28446253
Abstract

BACKGROUND

The present research aimed to investigate the efficacy of a multifaceted intervention that included motivational interviewing (MI) and psychoeducation in improving medication adherence (MA) among patients with bipolar disorder (BD).

METHOD

A multicenter, cluster randomized, observer-blind, controlled, parallel-group trial was conducted in ten academic centers in Iran. Patients with BD were randomly assigned to the experimental group (EXP; n = 136) or the usual care group (UC; n = 134). The EXP group received five sessions of MI and psychoeducation together with their family members. The primary outcome measure was changes in scores on the Medication Adherence Rating Scale from baseline to 6 months post-intervention. Other outcome measures included serum levels of mood stabilizers, clinical symptoms, quality of life, as well as measures of intention, beliefs about medicine, perceived behavioral control, automaticity, action and coping planning, and adverse reactions.

RESULTS

Medication adherence improved over time in both groups, but patients in the EXP group improved more (baseline score: 6.03; score at the sixth month: 9.55) than patients in the UC group (baseline score: 6.17; score at the sixth month: 6.67). In addition, patients in the EXP group showed greater improvement than patients in the UC group in almost all secondary outcomes 6 months following the intervention.

CONCLUSIONS

Multifaceted interventions that include motivational-interviewing and psychoeducation can significantly improve MA and clinical and functional outcomes in patients with BD.

TRIAL REGISTRATION NUMBER

The trial was registered with theClinicalTrials.gov database (NCT02241863) https://clinicaltrials.gov/ct2/show/NCT02241863.

摘要

背景

本研究旨在探讨一种多方面的干预措施,包括动机访谈(MI)和心理教育,以提高双相情感障碍(BD)患者的药物依从性(MA)。

方法

在伊朗的十个学术中心进行了一项多中心、集群随机、观察者盲、对照、平行组试验。BD 患者被随机分配到实验组(EXP;n=136)或常规护理组(UC;n=134)。EXP 组接受五次 MI 和心理教育,同时接受其家庭成员的教育。主要结局测量是干预后 6 个月时药物依从性评定量表评分的变化。其他结局测量包括情绪稳定剂的血清水平、临床症状、生活质量,以及意图、对药物的信念、感知行为控制、自动化、行动和应对计划以及不良反应的测量。

结果

两组患者的药物依从性随时间推移均有所改善,但实验组患者改善更明显(基线评分:6.03;第六个月评分:9.55),而 UC 组患者改善不明显(基线评分:6.17;第六个月评分:6.67)。此外,干预 6 个月后,实验组患者在几乎所有次要结局方面均优于 UC 组患者。

结论

包括动机访谈和心理教育在内的多方面干预措施可显著提高 BD 患者的 MA 和临床及功能结局。

试验注册号

该试验已在 ClinicalTrials.gov 数据库(NCT02241863)注册,网址为 https://clinicaltrials.gov/ct2/show/NCT02241863。

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