臨床研究等提出・公開システム

Japanese

Date of registration	June. 25, 2019
Last modified on	May. 13, 2022
Trial ID	jRCTs031190044

Scientific Title	False Safety Behavior Elimination Therapy for Generalized Anxiety Disorder-Randomized Clinical Trial Comparing Cognitive Behavioral Therapy and Pharmacological Treatment. (A pilot study of Cognitive Behavioral Therapy for Generalized Anxiety Disorder.)
Public Title	A pilot study of Cognitive Behavioral Therapy for Generalized Anxiety Disorder.

Contact for Scientific Queries	Name	Shimizu Eiji
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuouku, Chiba, Japan
	Telephone	+81-43-226-2027
	E-mail	eiji@faculty.chiba-u.jp
Contact for Public Queries	Name	Arai Honami
	Affiliation	Chiba University
	Address	1-8-1 Inohana, Chuouku, Chiba, Japan
	Telephone	+81-43-226-2975
	E-mail	aypa1127@chiba-u.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 25, 2019
Actual date of first enrollment		Sept. 20, 2019
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Generalized Anxiety Disorder
Intervention(s)		Cognitive Behavioral Therapy
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		030
Intervention(s) Code
Primary Outcome(s)		Mean Change From Baseline in Penn State Worry Questionnaire (PSWQ) Score [ Time Frame: Baseline , 5 weeks ]
Secondary Outcome(s)		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

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Society for the Promotion of Science
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuouku, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	May. 22, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	May. 13, 2022	(this page)	Changes
5	June. 29, 2021	Detail	Changes
4	Feb. 04, 2021	Detail	Changes
3	June. 10, 2020	Detail	Changes
2	Sept. 25, 2019	Detail	Changes
1	June. 25, 2019	Detail

List of change history