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Psychiatric Consultation Through Videoconference

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01901315
First received: July 10, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Depression
Procedure: Online consultation
Procedure: Face-to-face consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: New Telecommunication Technologies in Mental Health Care: Psychiatric Consultation Through Videoconference

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Baseline Depression Severity [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: Yes ]
    Instrument: Hamilton Depression Rating Scale

  • Change from Baseline in Depression Severity at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Instrument: Hamilton Depression Rating Scale

  • Change from Baseline and 6-months Follow-up in Depression Severity at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Instrument: Hamilton Depression Rating Scale

  • Baseline Satisfaction with Treatment [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: No ]
    Instrument: Client Satisfaction Questionnaire (CSQ-8)

  • Change from Baseline in Satisfaction with Treatment at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Instrument: Client Satisfaction Questionnaire (CSQ-8)

  • Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Instrument: Client Satisfaction Questionnaire (CSQ-8)

  • Baseline Mental Health [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: No ]
    Instrument: Mental Health Inventory (MHI)

  • Change from Baseline in Mental Health at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Instrument: Mental Health Inventory (MHI)

  • Change from Baseline and 6-months Follow-up in Mental Health at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Instrument: Mental Health Inventory (MHI)

  • Baseline Quality of Therapeutic Relationship [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: No ]
    Instrument: Working Alliance Inventory (WAI)

  • Change from Baseline in Quality of Therapeutic Relationship at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Instrument: Working Alliance Inventory (WAI)

  • Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Instrument: Working Alliance Inventory (WAI)

  • Baseline Medical Adherence [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: No ]

    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 in Medical Adherence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Demographics [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: No ]
    Age, Gender, Nationality, Marital Satus, Education, and Employment

  • Technical Control of Online Consultations at 6 an 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Assessment of technical aspects regarding to online consultations: sound quality, video quality, speed, technical support


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Online consultation 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 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hamilton Depression Rating Scale total score > 15
  • severe cognitive limitations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901315

Contacts
Contact: Ines Hungerbühler, MSc +55 11 2661 7654 ines.hungerbuehler@usp.br

Locations
Brazil
Institute of Psychiatry, School of Medicine, University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Ines Hungerbühler, MSc    +55 11 2661 7654    ines.hungerbuehler@usp.br   
Principal Investigator: Ines Hungerbühler, MSc         
Sub-Investigator: Rodrigo Machado-Vieira, Dr.         
Sub-Investigator: Chao Lung Wen, Prof. Dr.         
Sub-Investigator: Alexandre Andrade Loch         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Wagner F Gattaz, Prof. Dr. Institute of Psychiatry (IPq)
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01901315     History of Changes
Other Study ID Numbers: IPQ-0782/11
Study First Received: July 10, 2013
Last Updated: July 12, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
telepsychiatry
telemental health
teleassistance
health care delivery
depression
Telemedicine
Remote Consultation
Videoconferencing
Community Mental Health Services

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014