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临床试验/NCT01901315
NCT01901315已完成不适用

New Information and Communication Technologies in the Delivery of Mental Health Treatment: Psychiatric Care Via Videoconferencing

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
Baseline Depression Severity

研究概览

简要总结

The purpose of this project is to compare the effectiveness between face-to-face consultations and consultations via videoconferencing among patients treated in the Institute of Psychiatry (IPq).

详细描述

Introduction

Within the emergence of the Internet and for the purposes of providing psychiatric services across distances, the provision of mental health service via video counseling has become a possible way of mental health service delivery. An appropriate systematization of the propaedeutic methods in psychiatry, according to the interactive resources of telemedicine, and a standardized assessment based on clinical records turn this method to a viable alternative for service delivery all over the world. The main benefit of video counseling is an increased access to care services. But, so far, there is still limited research regarding to the effectiveness of telepsychiatry in the management of mental illnesses.

Objective

To verify the applicability of psychiatric attendance via Interned-based videoconferencing, comparing various quality characteristics between this method and face-to-face attendance, on the basis of a one-year follow-up study with a randomized clinical trial (RCT) design.

Material and methods

100 patients of the Institute of Psychiatry (IPq) between 18 to 55 years old with depressive disorders are randomly allocated to a control (monthly face-to-face consultation with the attending psychiatrist) or intervention group. The intervention group will have consultations with the attending psychiatrist through internet-based videoconference. For reasons of patient safety, consultations at baseline, and after 6 and 12 months will be realized in a face-to-face form for all patients. At baseline, and after 6 and 12 months mental health, satisfaction with treatment, therapeutic relationship, and medical compliance will be assessed. Depression will be assessed at baseline, and after 3, 6, 9 and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • depressive disorder
  • between 18 to 55 years
  • broadband Internet access

排除标准

  • Hamilton Depression Rating Scale total score > 15
  • severe cognitive limitations

结局指标

主要结局

Baseline Depression Severity

时间窗: 0 months (baseline)

Instrument: Hamilton Depression Rating Scale

Change from Baseline in Depression Severity at 6 months

时间窗: 6 months

Instrument: Hamilton Depression Rating Scale

Change from Baseline and 6-months Follow-up in Depression Severity at 12 months

时间窗: 12 months

Instrument: Hamilton Depression Rating Scale

Baseline Satisfaction with Treatment

时间窗: 0 months (baseline)

Instrument: Client Satisfaction Questionnaire (CSQ-8)

Change from Baseline in Satisfaction with Treatment at 6 months

时间窗: 6 months

Instrument: Client Satisfaction Questionnaire (CSQ-8)

Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months

时间窗: 12 months

Instrument: Client Satisfaction Questionnaire (CSQ-8)

Baseline Mental Health

时间窗: 0 months (baseline)

Instrument: Mental Health Inventory (MHI)

Change from Baseline in Mental Health at 6 months

时间窗: 6 months

Instrument: Mental Health Inventory (MHI)

Change from Baseline and 6-months Follow-up in Mental Health at 12 months

时间窗: 12 months

Instrument: Mental Health Inventory (MHI)

Baseline Quality of Therapeutic Relationship

时间窗: 0 months (baseline)

Instrument: Working Alliance Inventory (WAI)

Change from Baseline in Quality of Therapeutic Relationship at 6 months

时间窗: 6 months

Instrument: Working Alliance Inventory (WAI)

Change from Baseline in Medical Adherence at 6 months

时间窗: 6 months

Instrument: self-reported measure of medication adherence with four items: * Do you forget to take your medication? * Are you careless at times about taking your medicine? * When you feel better, do you sometimes stop taking your medicine? * Sometimes when you feel worse, do you stop taking your medicine? Response categories are yes/no for each item with a dichotomous response and a 5-point Likert response for the last item.

Change from Baseline and 6-months Follow-up in Medical Adherence at 12 months

时间窗: 12 months

Instrument: self-reported measure of medication adherence with four items: * Do you forget to take your medication? * Are you careless at times about taking your medicine? * When you feel better, do you sometimes stop taking your medicine? * Sometimes when you feel worse, do you stop taking your medicine? Response categories are yes/no for each item with a dichotomous response and a 5-point Likert response for the last item.

Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months

时间窗: 12 months

Instrument: Working Alliance Inventory (WAI)

Baseline Medical Adherence

时间窗: 0 months (baseline)

Instrument: self-reported measure of medication adherence with four items: * Do you forget to take your medication? * Are you careless at times about taking your medicine? * When you feel better, do you sometimes stop taking your medicine? * Sometimes when you feel worse, do you stop taking your medicine? Response categories are yes/no for each item with a dichotomous response and a 5-point Likert response for the last item.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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