NCT01901315

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

July 1, 2013

Enrollment Period

3.1 years

First QC Date

July 10, 2013

Last Update Submit

May 21, 2015

Conditions

Depression

Keywords

telepsychiatrytelemental healthteleassistancehealth care deliverydepressionTelemedicineRemote ConsultationVideoconferencingCommunity Mental Health Services

Outcome Measures

Primary Outcomes (15)

  • Baseline Depression Severity

    Instrument: Hamilton Depression Rating Scale

    0 months (baseline)

  • Change from Baseline in Depression Severity at 6 months

    Instrument: Hamilton Depression Rating Scale

    6 months

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

    Instrument: Hamilton Depression Rating Scale

    12 months

  • Baseline Satisfaction with Treatment

    Instrument: Client Satisfaction Questionnaire (CSQ-8)

    0 months (baseline)

  • Change from Baseline in Satisfaction with Treatment at 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

    Instrument: Client Satisfaction Questionnaire (CSQ-8)

    12 months

  • Baseline Mental Health

    Instrument: Mental Health Inventory (MHI)

    0 months (baseline)

  • Change from Baseline in Mental Health at 6 months

    Instrument: Mental Health Inventory (MHI)

    6 months

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

    Instrument: Mental Health Inventory (MHI)

    12 months

  • Baseline Quality of Therapeutic Relationship

    Instrument: Working Alliance Inventory (WAI)

    0 months (baseline)

  • Change from Baseline in Quality of Therapeutic Relationship at 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

    Instrument: Working Alliance Inventory (WAI)

    12 months

  • Baseline Medical Adherence

    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

    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

    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 Outcomes (2)

  • Demographics

    0 months (baseline)

  • Technical Control of Online Consultations at 6 an 12 months

    6 and 12 months

Study Arms (2)

Online consultation

EXPERIMENTAL

Monthly video consultations with psychiatrist

Procedure: Online consultation

Face-to-face consultation

EXPERIMENTAL

Monthly face-to-face consultations with psychiatrist

Procedure: Face-to-face consultation

Interventions

Online consultationPROCEDURE

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).

Online consultation
Face-to-face consultationPROCEDURE

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).

Face-to-face consultation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • Hungerbuehler I, Valiengo L, Loch AA, Rossler W, Gattaz WF. Home-Based Psychiatric Outpatient Care Through Videoconferencing for Depression: A Randomized Controlled Follow-Up Trial. JMIR Ment Health. 2016 Aug 3;3(3):e36. doi: 10.2196/mental.5675.

    PMID: 27489204DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Wagner F Gattaz, Prof. Dr.

    Institute of Psychiatry (IPq)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

March 1, 2012

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 22, 2015

Record last verified: 2013-07

Locations

BR(1)