Clinical trial NCT01901315: Psychiatric Care Via Videoconferencing
Official title: New Information and Communication Technologies in the Delivery of Mental Health Treatment: Psychiatric Care Via Videoconferencing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: telepsychiatry
telemental health
teleassistance
health care delivery
depression
Telemedicine
Remote Consultation
Videoconferencing
Community Mental Health Services
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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 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

Primary outcomes:
measure: Baseline Depression Severity
timeFrame: 0 months (baseline)
measure: Change from Baseline in Depression Severity at 6 months
timeFrame: 6 months
measure: Change from Baseline and 6-months Follow-up in Depression Severity at 12 months
timeFrame: 12 months
measure: Baseline Satisfaction with Treatment
timeFrame: 0 months (baseline)
measure: Change from Baseline in Satisfaction with Treatment at 6 months
timeFrame: 6 months
measure: Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months
timeFrame: 12 months
measure: Baseline Mental Health
timeFrame: 0 months (baseline)
measure: Change from Baseline in Mental Health at 6 months
timeFrame: 6 months
measure: Change from Baseline and 6-months Follow-up in Mental Health at 12 months
timeFrame: 12 months
measure: Baseline Quality of Therapeutic Relationship
timeFrame: 0 months (baseline)
measure: Change from Baseline in Quality of Therapeutic Relationship at 6 months
timeFrame: 6 months
measure: Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months
timeFrame: 12 months
measure: Baseline Medical Adherence
timeFrame: 0 months (baseline)
measure: Change from Baseline in Medical Adherence at 6 months
timeFrame: 6 months
measure: Change from Baseline and 6-months Follow-up in Medical Adherence at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Demographics
timeFrame: 0 months (baseline)
measure: Technical Control of Online Consultations at 6 an 12 months
timeFrame: 6 and 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry, School of Medicine, University of Sao Paulo
Study officials:
affiliation: Institute of Psychiatry (IPq)
name: Wagner F Gattaz, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.