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JRCT ID: jRCTs031190044

Registered date:25/06/2019

A pilot study of Cognitive Behavioral Therapy for Generalized Anxiety Disorder.

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedGeneralized Anxiety Disorder
Date of first enrollment20/09/2019
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Cognitive Behavioral Therapy


Primary OutcomeMean Change From Baseline in Penn State Worry Questionnaire (PSWQ) Score [ Time Frame: Baseline , 5 weeks ]
Secondary OutcomeMean change from baseline to 5 weeks and 9 weeks of the following scales (9 weeks is only for COMB group). 1. Penn State Worry Questionnaire Score 2. Patient Health Questionnaire-9 3. Generalized Anxiety Disorder -7 4. EuroQOL5dimension 5. Subtle Avoidance Frequency Examination 6. Anxiety Control Questionnaire 7. Beck Depression Inventory II 8. Sheehan Disability Scale 9. Clinical Global Impression -Severity 10. Beck Anxiety Inventory 11. Name of psychotropic drug and daily dose

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 65age old
Include criteria(1)Primary diagnosis of Generalized Anxiety Disorder using the Mini- International Neuropsychiatric Interview, DSM-5. (2)The age between 18 to 65. (3)Patients with full consent of participation in the study. (4)Patients' PSWQ score is above 45. (5)No change of medical drugs during the study. (6)Possible to understand cognitive behavioral therapy, and has mental and physical condition that can be participate the session for at least one year. (7)If Generalized Anxiety Disorder is primary diagnosed, patients with Social Anxiety Disorder, Major Depressive Disorder, Agoraphobia will not be excluded from the study.
Exclude criteria1. Psychosis, major depression, bipolar, organic brain disorder, substance abuse or dependence, other severe mental, physical condition. 2. Active suicidality 3. Repetitive anti-social behavior 4. Severe physical condition 5. IQ under 80;JART25: Japanese Adult Reading Test25 6. Autistic Spectrum Disorder 7. Patients who cannot contact with the study organizer 8. Other relevant reason decided by the investigators

Related Information


Public contact
Name Honami Arai
Address 1-8-1 Inohana, Chuouku, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-226-2975
Affiliation Chiba University
Scientific contact
Name Eiji Shimizu
Address 1-8-1 Inohana, Chuouku, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-226-2027
Affiliation Chiba University Hospital