DepressionNCT01901315
Psychiatric Care Via Videoconferencing
A study testing Online consultation and Face-to-face consultation in people with Depression, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- Online consultation and Face-to-face consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- depressive disorder
- between 18 to 55 years
- broadband Internet access
Who cannot join
- Hamilton Depression Rating Scale total score > 15
- severe cognitive limitations
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, School of Medicine, University of Sao Paulo
São Paulo, São Paulo, 05403-010
About this study
Official title: 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).
Read the 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.
- Conditions
- Depression
- Being tested
- Online consultation, Face-to-face consultation
- Keywords
- telepsychiatry, telemental health, teleassistance, health care delivery, depression, Telemedicine, Remote Consultation, Videoconferencing, Community Mental Health Services
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online consultationProcedure or surgery
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 consultationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Online consultation | Experimental | Monthly video consultations with psychiatrist Receives: Procedure: Online consultation |
| Face-to-face consultation | Experimental | Monthly face-to-face consultations with psychiatrist Receives: Procedure: Face-to-face consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Depression Severity
Instrument: Hamilton Depression Rating Scale
Measured: 0 months (baseline)
Change from Baseline in Depression Severity at 6 months
Instrument: Hamilton Depression Rating Scale
Measured: 6 months
Change from Baseline and 6-months Follow-up in Depression Severity at 12 months
Instrument: Hamilton Depression Rating Scale
Measured: 12 months
Baseline Satisfaction with Treatment
Instrument: Client Satisfaction Questionnaire (CSQ-8)
Measured: 0 months (baseline)
Change from Baseline in Satisfaction with Treatment at 6 months
Instrument: Client Satisfaction Questionnaire (CSQ-8)
Measured: 6 months
Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months
Instrument: Client Satisfaction Questionnaire (CSQ-8)
Measured: 12 months
Baseline Mental Health
Instrument: Mental Health Inventory (MHI)
Measured: 0 months (baseline)
Change from Baseline in Mental Health at 6 months
Instrument: Mental Health Inventory (MHI)
Measured: 6 months
Change from Baseline and 6-months Follow-up in Mental Health at 12 months
Instrument: Mental Health Inventory (MHI)
Measured: 12 months
Baseline Quality of Therapeutic Relationship
Instrument: Working Alliance Inventory (WAI)
Measured: 0 months (baseline)
Change from Baseline in Quality of Therapeutic Relationship at 6 months
Instrument: Working Alliance Inventory (WAI)
Measured: 6 months
Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months
Instrument: Working Alliance Inventory (WAI)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wagner F Gattaz, Prof. Dr., Study director, Institute of Psychiatry (IPq)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901315
- Sponsor's protocol ID
- IPQ-0782/11
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27489204
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Information and Communication Technologies in the Delivery of Mental Health Treatment: Psychiatric Care Via Videoconferencing
- ClinicalTrials.gov ID
- NCT01901315
- Acronym / sponsor ID
- IPQ-0782/11
- Conditions
- Depression
- Keywords
- telepsychiatry, telemental health, teleassistance, health care delivery, depression, Telemedicine, Remote Consultation, Videoconferencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online consultation | Experimental | Procedure: Online consultationMonthly video consultations with psychiatrist |
| Face-to-face consultation | Experimental | Procedure: Face-to-face consultationMonthly face-to-face consultations with psychiatrist |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- depressive disorder
- between 18 to 55 years
- broadband Internet access
Key exclusion criteria (2 listed)
- Hamilton Depression Rating Scale total score > 15
- severe cognitive limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online consultationPatients 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). | Procedure or surgery | Online consultation |
| Face-to-face consultationPatients 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). | Procedure or surgery | Face-to-face consultation |
Primary outcome
Baseline Depression Severity
Time frame: 0 months (baseline)
Instrument: Hamilton Depression Rating Scale
Change from Baseline in Depression Severity at 6 months
Time frame: 6 months
Instrument: Hamilton Depression Rating Scale
Change from Baseline and 6-months Follow-up in Depression Severity at 12 months
Time frame: 12 months
Instrument: Hamilton Depression Rating Scale
Baseline Satisfaction with Treatment
Time frame: 0 months (baseline)
Instrument: Client Satisfaction Questionnaire (CSQ-8)
Change from Baseline in Satisfaction with Treatment at 6 months
Time frame: 6 months
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
Instrument: Client Satisfaction Questionnaire (CSQ-8)
Baseline Mental Health
Time frame: 0 months (baseline)
Instrument: Mental Health Inventory (MHI)
Change from Baseline in Mental Health at 6 months
Time frame: 6 months
Instrument: Mental Health Inventory (MHI)
Change from Baseline and 6-months Follow-up in Mental Health at 12 months
Time frame: 12 months
Instrument: Mental Health Inventory (MHI)
Baseline Quality of Therapeutic Relationship
Time frame: 0 months (baseline)
Instrument: Working Alliance Inventory (WAI)
Change from Baseline in Quality of Therapeutic Relationship at 6 months
Time frame: 6 months
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
Instrument: Working Alliance Inventory (WAI)
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Derived from this study: PubMed 27489204Hungerbuehler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wagner F Gattaz, Prof. Dr. study director
Institute of Psychiatry (IPq)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online consultation and Face-to-face consultation in people with Depression, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Depression Severity (time frame: 0 months (baseline)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.