Major depression
Conditions
Interventions
16 weeks of web-based cognitive behavioral therapy blended with face-to-face or videoconference sessions for major depression in addition to treatment as usual
16 weeks of treatment as usual
Sponsors
Keio University School of Medicine
Kyorin University Ehime University Hokkaido University Kyushu University Hiroshima University Kanazawa Medical University St. Marianna University Nagoya University National Hospital Organization Tokyo Medical Center Heartland Shigisan Shigisan Mental Clinic Gakuenmae Uwajima Hospital Toyosato Hospital Tokyo Adachi Hospital Sakuragaoka Memorial Hospital Aizato Hospital Shin-Abuyama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) having a diagnosis of DSM-IV Major Depressive Disorder 2) QIDS>=11 3) have a smartphone, tablet, or personal computer that can connect to the internet 4) can attend session more than 8 5) 20 years old <= age <=70 years old 6) obtain written consent
Exclusion criteria
Exclusion criteria: 1) No alcohol or substance use disorder in 12 months prior to the screening 2) No history or concurrent hypomanic episode, manic episode or psychotic disorders 3) No other primary DSM-IV Axis I Disorders at screening 4) No serious suicidal ideation at screening 5) No organic brain lesions or major cognitive deficits in a year prior to the screening 6) No severe or unstable medical co-morbidities at screening 7) No structured psychotherapy during the intervention 8) Other relevant reason decided by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (defined as 50% reduction of baseline Quick Inventory of Depressive Symptomatology: QIDS) and dropout rate at 16wk | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline reduction score of QIDS at 16,32wks (post randomization) 2. Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), functional disability scale, Client satisfaction questionnaire (CSQ-8j), WHO Health and Work Performance Questionnaire (HPQ): 0,16,32wks 3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session 4. Credibility/ Expectancy Questionnaire (CEQ): 0wk 5. Incremental cost-effectiveness ratio (ICER) | — |
Countries
Japan
Contacts
Public ContactAtsuo Nakagawa, MD, PhD
Keio University School of Medicine Department of Neuropsychiatry
Outcome results
None listed