【ChiCTR2100050197】The effectiveness of MICM to improve medication adherence for dual-diagnosed patients

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基本信息

登记号

ChiCTR2100050197

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-08-22

临床申请受理号

靶点

适应症

SUBSTANCE USE DISORDER WITH ANY TYPE OF PSYCHIATRIC DISORDERS

试验通俗题目

The effectiveness of MICM to improve medication adherence for dual-diagnosed patients

试验专业题目

A pilot randomized controlled trial of integrative Motivational Interviewing and Contingency Management program (MICM) for dual-diagnosed patients to enhance psychiatric medication adherence

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

The proposed project will adopt a single-blinded, multi-centre pilot randomized controlled trial (RCT) design to determine the feasibility and preliminary effectiveness of a multi-model, integrative Motivational Interviewing and Contingency Management program (MICM), in comparison with the usual care (i.e., case management), at immediately after intervention and 3-months post-intervention. The following outcomes will be assessed: 1. medication adherence (primary outcome); and 2. psychiatric symptoms, frequency of substance abuse and psychiatric hospitalizations (secondary outcomes). Moreover, the perceived usefulness and areas of improvement of the MICM program will be evaluated to make necessary improvement in the future clinical application.

试验分类

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试验类型

随机抽样

试验分期

Ⅰ期

随机化

Block randomization with block size of 6-8 will be used to maintain a balanced number of participants in both groups (Efird, 2011). A sequence of group identifiers (I or C) based on computer-generated random codes is prepared in advance and put in serially numbered sealed opaque envelopes by a clerical&

盲法

The researcher who is also the intervention deliverer will not know which participant will be assigned to which group before opening of opaque envelope. After allocation has been done, both participants and researcher cannot be blinded.

试验项目经费来源

SELF

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-08-23

试验终止时间

2022-12-31

是否属于一致性

入选标准

1. Adults, aged 18-64 years Hong Kong residents; 2. Diagnosed with substance-use disorder and comorbid with at least one type of other mental disorder in the Diagnostic and Statistical Manual – fourth version (text revised) (DSM-IV-TR) / fifth version (DSM-5), or International Classification of Diseases – 10th (ICD-10) / 11th version (ICD-11); 3. Able to give written consent as recommended by psychiatrist and read/write Chinese language; 4. Being prescribed at least one type of oral psychiatric medication.；

排除标准

1. Having organic psychiatric disorder AND/OR learning disability; 2. Having been prescribed depot-only (injection) medication or no medication; 3. Having visual, language or communication difficulties.；

研究者信息

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试验机构

N/A

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研究负责人邮编

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