A randomized controlled trial of internet-assisted Cognitive Behavioral Therapy for depressio

Phase 3

• Conditions: Major Depressive Disorder

• Registration Number: JPRN-UMIN000009242
• Lead Sponsor: i-CBT study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-01
• Study Completion: 2016-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1.No alcohol or substance use disorder in 6 months prior to the screening. 2.No history or concurrent manic or psychotic episode. 3.No other primary DSM-IV Axis I Disorders at screening. 4.No comorbid of antisocial personality disorder. 5.No serious suicidal ideation at screening. 6.No past treatment of individual CBT. 7.No organic brain lesions or major cognitive deficits in a year prior to the screening. 8.No severe or unstable medical co-morbidities at screening. 9.Other relevant reason decided by the i-CBT principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD-17) score at endpoint will be compared between the groups

Secondary Outcome Measures

Name	Time	Method
Response rate(defined as 50% reduction of baseline HAMD-17),remission rate(defined as HAMD=<7),subjective depression(measured with the BDI and QIDS),quality of life(measured with EQ-5D and SF-36) and vulnerability measure of depression and cognition (DAS) at 12week and post-intervention phase(up to 6months) will be compared between the groups.Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups.