- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901315
Psychiatric Care Via Videoconferencing
New Information and Communication Technologies in the Delivery of Mental Health Treatment: Psychiatric Care Via Videoconferencing
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sao Paulo, Brazil, 05403-010
- Institute of Psychiatry, School of Medicine, University of Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Online consultation
Monthly video consultations with psychiatrist
|
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
|
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
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:
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:
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:
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
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
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Assessment of technical aspects regarding to online consultations: sound quality, video quality, speed, technical support
|
6 and 12 months
|
Collaborators and Investigators
Investigators
- Study Director: Wagner F Gattaz, Prof. Dr., Institute of Psychiatry (IPq)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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