Psychiatric Care Via Videoconferencing

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

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).

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 05403-010
        • Institute of Psychiatry, School of Medicine, University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online consultation
Monthly video consultations with psychiatrist
Patients in the online consultation (intervention) group have monthly consultation with their attending psychiatrist through videoconferencing during one year. After each consultation, the medication is sent to the patient through a home delivery program. For reasons of patient safety, consultations at baseline, and after 6 and 12 months will be realized in a face-to-face form at the Institute of Psychiatry (IPq).
Experimental: Face-to-face consultation
Monthly face-to-face consultations with psychiatrist
Patients in the face-to-face consultation (control) group have monthly face-to-face consultation with their attending psychiatrist during one year at the Institute of Psychiatry (IPq).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Depression Severity
Time Frame: 0 months (baseline)
Instrument: Hamilton Depression Rating Scale
0 months (baseline)
Change from Baseline in Depression Severity at 6 months
Time Frame: 6 months
Instrument: Hamilton Depression Rating Scale
6 months
Change from Baseline and 6-months Follow-up in Depression Severity at 12 months
Time Frame: 12 months
Instrument: Hamilton Depression Rating Scale
12 months
Baseline Satisfaction with Treatment
Time Frame: 0 months (baseline)
Instrument: Client Satisfaction Questionnaire (CSQ-8)
0 months (baseline)
Change from Baseline in Satisfaction with Treatment at 6 months
Time Frame: 6 months
Instrument: Client Satisfaction Questionnaire (CSQ-8)
6 months
Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months
Time Frame: 12 months
Instrument: Client Satisfaction Questionnaire (CSQ-8)
12 months
Baseline Mental Health
Time Frame: 0 months (baseline)
Instrument: Mental Health Inventory (MHI)
0 months (baseline)
Change from Baseline in Mental Health at 6 months
Time Frame: 6 months
Instrument: Mental Health Inventory (MHI)
6 months
Change from Baseline and 6-months Follow-up in Mental Health at 12 months
Time Frame: 12 months
Instrument: Mental Health Inventory (MHI)
12 months
Baseline Quality of Therapeutic Relationship
Time Frame: 0 months (baseline)
Instrument: Working Alliance Inventory (WAI)
0 months (baseline)
Change from Baseline in Quality of Therapeutic Relationship at 6 months
Time Frame: 6 months
Instrument: Working Alliance Inventory (WAI)
6 months
Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months
Time Frame: 12 months
Instrument: Working Alliance Inventory (WAI)
12 months
Baseline Medical Adherence
Time Frame: 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.

0 months (baseline)
Change from Baseline in Medical Adherence at 6 months
Time Frame: 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.

6 months
Change from Baseline and 6-months Follow-up in Medical Adherence at 12 months
Time Frame: 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.

12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: 0 months (baseline)
Age, Gender, Nationality, Marital Satus, Education, and Employment
0 months (baseline)
Technical Control of Online Consultations at 6 an 12 months
Time Frame: 6 and 12 months
Assessment of technical aspects regarding to online consultations: sound quality, video quality, speed, technical support
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Wagner F Gattaz, Prof. Dr., Institute of Psychiatry (IPq)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

July 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Online consultation

Subscribe