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

JRCT ID: jRCTs031190044

Registered date:25/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Generalized Anxiety Disorder
• Date of first enrollment: 20/09/2019
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Cognitive Behavioral Therapy

Outcome(s)

• Primary Outcome: Mean Change From Baseline in Penn State Worry Questionnaire (PSWQ) Score [ Time Frame: Baseline , 5 weeks ]

Secondary Outcome

Mean 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
• Gender: Both

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 criteria

1. 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

• Primary Sponsor: Shimizu Eiji
• Source(s) of Monetary Support: Japan Society for the Promotion of Science