Psychiatric Care Via Videoconferencing

May 21, 2015 updated by: University of Sao Paulo General Hospital

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online consultation
Monthly video consultations with psychiatrist
Procedure: Online consultation
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
Procedure: Face-to-face consultation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPQ-0782/11

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.

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