Psychiatric Care Via Videoconferencing

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901315
• Other study ID #: IPQ-0782/11
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: May 21, 2015
• Start date: March 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression

Intervention

Procedure:
• Online consultation
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
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).

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry, School of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Age, Gender, Nationality, Marital Satus, Education, and Employment	0 months (baseline)	No
Other	Technical Control of Online Consultations at 6 an 12 months	Assessment of technical aspects regarding to online consultations: sound quality, video quality, speed, technical support	6 and 12 months	No
Primary	Baseline Depression Severity	Instrument: Hamilton Depression Rating Scale	0 months (baseline)	Yes
Primary	Change from Baseline in Depression Severity at 6 months	Instrument: Hamilton Depression Rating Scale	6 months	Yes
Primary	Change from Baseline and 6-months Follow-up in Depression Severity at 12 months	Instrument: Hamilton Depression Rating Scale	12 months	Yes
Primary	Baseline Satisfaction with Treatment	Instrument: Client Satisfaction Questionnaire (CSQ-8)	0 months (baseline)	No
Primary	Change from Baseline in Satisfaction with Treatment at 6 months	Instrument: Client Satisfaction Questionnaire (CSQ-8)	6 months	No
Primary	Change from Baseline and 6-months Follow-up in Satisfaction with Treatment at 12 months	Instrument: Client Satisfaction Questionnaire (CSQ-8)	12 months	No
Primary	Baseline Mental Health	Instrument: Mental Health Inventory (MHI)	0 months (baseline)	No
Primary	Change from Baseline in Mental Health at 6 months	Instrument: Mental Health Inventory (MHI)	6 months	No
Primary	Change from Baseline and 6-months Follow-up in Mental Health at 12 months	Instrument: Mental Health Inventory (MHI)	12 months	No
Primary	Baseline Quality of Therapeutic Relationship	Instrument: Working Alliance Inventory (WAI)	0 months (baseline)	No
Primary	Change from Baseline in Quality of Therapeutic Relationship at 6 months	Instrument: Working Alliance Inventory (WAI)	6 months	No
Primary	Change from Baseline and 6-months Follow-up in Quality of Therapeutic Relationship at 12 months	Instrument: Working Alliance Inventory (WAI)	12 months	No
Primary	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)	No
Primary	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	No
Primary	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	No