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Completed

NCT Number: NCT01901315

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychiatry, School of Medicine, University of Sao Paulo

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Online consultation

Procedure

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).

Face-to-face consultation

Procedure

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).

Primary outcomes

  1. Baseline Depression Severity

    Time frame: 0 months (baseline)

    Instrument: Hamilton Depression Rating Scale

  2. Change from Baseline in Depression Severity at 6 months

    Time frame: 6 months

    Instrument: Hamilton Depression Rating Scale

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

    Time frame: 12 months

    Instrument: Hamilton Depression Rating Scale

  4. Baseline Satisfaction with Treatment

    Time frame: 0 months (baseline)

    Instrument: Client Satisfaction Questionnaire (CSQ-8)

  5. Change from Baseline in Satisfaction with Treatment at 6 months

    Time frame: 6 months

    Instrument: Client Satisfaction Questionnaire (CSQ-8)

  6. 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)

  7. Baseline Mental Health

    Time frame: 0 months (baseline)

    Instrument: Mental Health Inventory (MHI)

  8. Change from Baseline in Mental Health at 6 months

    Time frame: 6 months

    Instrument: Mental Health Inventory (MHI)

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

    Time frame: 12 months

    Instrument: Mental Health Inventory (MHI)

  10. Baseline Quality of Therapeutic Relationship

    Time frame: 0 months (baseline)

    Instrument: Working Alliance Inventory (WAI)

  11. Change from Baseline in Quality of Therapeutic Relationship at 6 months

    Time frame: 6 months

    Instrument: Working Alliance Inventory (WAI)

  12. 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)

  13. 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.

  14. 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.

  15. 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.

Other outcomes

  1. Demographics

    Time frame: 0 months (baseline)

    Age, Gender, Nationality, Marital Satus, Education, and Employment

  2. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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