UMIN ID: UMIN000036911
Registered date:31/05/2019
Web-Based Cognitive Behavioral Therapy Blended With Videoconference Face-to-Face Sessions for Major Depression: A feasibility study
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Major Depression |
Date of first enrollment | 2019/06/13 |
Target sample size | 8 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Web-Based Cognitive Behavioral Therapy Blended With Videoconference Sessions for Major Depression |
Outcome(s)
Primary Outcome | 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 12wk 2. Drop-out rate |
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Secondary Outcome | 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 24 and 36wk 2. Beck Depression Inventory (BDI-II), Generalized Anxiety Disorder (GAD-7), Ruminative Responses Scale (RRS), Sheehan Disability Scale (SDISS), Cognitive-Behavioral Avoidance Scale (CBAS), Coping Inventory for Stressful Situations (CISS): 0,6,12,24,36 wks 3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session 4. Client satisfaction questionnaire (CSQ-8j): 0, 6,12 wks |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 70years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) No alcohol or substance use disorder in 12 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 organic brain lesions or major cognitive deficits in a year prior to the screening 7) No severe or unstable medical co-morbidities at screening 8) No past treatment of individual CBT sessions more than 8 9) No structured psychotherapy during the intervention 10) Other relevant reason decided by the CBT principal investigator |
Related Information
Primary Sponsor | Keio University School of Medicine, Department of Neuropsychiatry |
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Secondary Sponsor | |
Source(s) of Monetary Support | National Center of Neurology and Psychiatry |
Secondary ID(s) |
Contact
public contact | |
Name | Atsuo Nakagawa, MD, PhD |
Address | Shinanomachi 35, Shinjuku-ku, Tokyo, Japan Japan 160-8582 |
Telephone | 03-5363-3235 |
anakagawa@keio.jp | |
Affiliation | Keio University School of Medicine Department of Neuropsychiatry |
scientific contact | |
Name | Atsuo Nakagawa, MD, PhD |
Address | Shinanomachi 35, Shinjuku-ku, Tokyo, Japan Japan |
Telephone | 03-5363-3235 |
anakagawa@keio.jp | |
Affiliation | Keio University School of Medicine Department of Neuropsychiatry |