Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial

Not Applicable

• Conditions: Depressive disorders, anxiety disorders, obsessive-compulsive and related disorders; D003866, D001007, D009771

• Registration Number: JPRN-jRCT1030210037
• Lead Sponsor: Kishimoto Taishiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Outpatients at the study sites who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for depressive disorder, anxiety disorder, and obsessive-compulsive disorder and related disorders.
2) Patients aged 18 years or older at the time of consent.
3) Patients requiring continuous treatment for 6 months or longer (judged by the primary physician).
4) Patients who have smartphones or PCs and can make video calls (with support from their family members).
5) Patients whose primary physician judged telemedicine can be applied based on their condition of the diseases.
6) Patients judged to have sufficient ability to give consent based on the condition of their diseases.
7) Patients who have given written consent to participate in the study. In the case of minors, patients as well as their guardian must give written consent.

Exclusion Criteria

1) Patients who have strong suicidal ideation or who are expected to require unscheduled or urgent visits in addition to their regular visits due to strong anxiety and agitation.
2) Patients who cannot visit the hospital immediately in the case of emergency (for example, hospital is located far away from their home).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form-36 Mental Component Summary (SF-36 MCS) (assessed on baseline, week12, week24)

Secondary Outcome Measures

Name	Time	Method
1) MOS 36-Item Short-Form Health Survey (SF36) (assessed on baseline, week12 and week24)<br>2) Dropout rate<br>3) Working Alliance Inventory (WAI)<br>4) Client Satisfaction Questionnaire (CSQ)<br>5) Adverse event<br>6) Questionnaire on costs associated with consultation (self-reported)<br>7) EQ-5D (EuroQol 5 Dimension)<br>8) Degree of anxiety about COVID-19<br>9) Impression of telemedicine<br>10) Hamilton Depression Rating Scale (HAMD) (For depressive disorder group)<br>11) Hamilton Anxiety Rating Scale (HAMA) (For anxiety disorder group)<br>12) Yale-Brown Obsessive Compulsive Scale (YBOCS) (For obsessive-compulsive and related disorder group)