UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038019 |
|---|---|
| Receipt number | R000043343 |
| Scientific Title | Accompaniment study:Effect study of the treatment as usual group of the randomized controlled trial of the cognitive-behavioral therapy for generalized anxiety disorder patients |
| Date of disclosure of the study information | 2019/09/17 |
| Last modified on | 2022/06/23 11:52:19 |
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Basic information
Public title
Accompaniment study:Effect study of the treatment as usual group of the randomized controlled trial of the cognitive-behavioral therapy for generalized anxiety disorder patients
Acronym
Effect study of the TAU group in RCT of the cognitive-behavioral therapy for generalized anxiety disorder patients
Scientific Title
Accompaniment study:Effect study of the treatment as usual group of the randomized controlled trial of the cognitive-behavioral therapy for generalized anxiety disorder patients
Scientific Title:Acronym
Effect study of the TAU group in RCT of the cognitive-behavioral therapy for generalized anxiety disorder patients
Region
| Japan |
Condition
Condition
Generalized Anxiety Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of effects when applying cognitive behavioral therapy to TAU group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Penn State Worry Questionnaire (PSWQ)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cognitive behavioral therapy (5sessions)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key 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.
Key exclusion criteria
psychosis, major depression, bipolar, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Chiba University,Chiba University Hospital
Division name
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology,Cognitive Behavioral Therapy Center
Zip code
2608670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Honami |
| Middle name | |
| Last name | Arai |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
2608670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
Homepage URL
aypa1127@chiba-u.ac.jp
Sponsor or person
Institute
Chiba University Hospital Clinical Research Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
Clinical Research Center
Tel
043-226-2027
prc-jim@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 24 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043343
