UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059428 |
|---|---|
| Receipt number | R000067810 |
| Scientific Title | One-Year Follow-Up Prognosis Study in Adults with Generalized Anxiety Disorder |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/16 09:56:29 |
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Basic information
Public title
One-Year Follow-Up Study on the Prognosis of Adult Patients with Generalized Anxiety Disorder
Acronym
GAD-FU
Scientific Title
One-Year Follow-Up Prognosis Study in Adults with Generalized Anxiety Disorder
Scientific Title:Acronym
GAD-1YFU Study
Region
| Japan |
Condition
Condition
Generalized Anxiety Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients who participated in the randomized controlled trial "Online Cognitive Behavioral Therapy in Addition to Treatment-as-Usual versus Treatment-as-Usual Alone for Adult Patients with Generalized Anxiety Disorder (G2023010)" will be followed up within the scope of routine clinical practice, and changes in clinical data will be observed. Since the natural course of one-year changes following online cognitive behavioral therapy for generalized anxiety disorder has not yet been clarified, it is of clinical significance to conduct follow-up and observational assessments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of anxiety using the Hamilton Anxiety Rating Scale (HAM-A)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who meet all of the following criteria will be included:
The primary diagnosis meets the diagnostic criteria for generalized anxiety disorder (DSM-5).
Age between 18 and 65 years at the time of obtaining informed consent.
Written informed consent is obtained voluntarily from the patient after receiving a sufficient explanation of the study and demonstrating adequate understanding.
Usual treatment (regular consultations with a primary physician are mandatory, and the presence or absence of pharmacotherapy for generalized anxiety disorder at the time of entry is not restricted) is being provided, and no new initiation or additional changes in pharmacotherapy for generalized anxiety disorder are planned during the study period.
Pharmacotherapy for generalized anxiety disorder refers to psychotropic medications such as antidepressants, anxiolytics, or hypnotics, regardless of indication.
The patient is able to understand cognitive behavioral therapy and is in a mental and physical condition that allows for continuous practice for at least 16 weeks.
Key exclusion criteria
The following individuals will be excluded:
Those with comorbid schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance-related and addictive disorders, neurocognitive disorders, or neurodevelopmental disorders.
Those at imminent risk of suicide.
Those with serious physical illnesses such as cancer, heart disease, or stroke.
Those with intellectual disability (estimated IQ < 80 based on the JART-25: Japanese Adult Reading Test-25 or similar measures).
Those who have received cognitive behavioral therapy within the past six months.
Any other individuals deemed unsuitable for safe participation in this study by the principal investigator or study therapists.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Cognitive Behavioral Physiology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432262027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Itsuko |
| Middle name | |
| Last name | Yoshida |
Organization
Chiba University
Division name
Cognitive Behavioral Physiology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432262027
Homepage URL
tokiko.yoshida@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
0432227171
trad-project@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
| 2025 | Year | 10 | Month | 23 | 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
24
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations using assessment scales commonly employed in routine clinical practice, as well as patient satisfaction and reflection sheets, will be conducted at 1 month, 3 months, 6 months, and 1 year after the completion of the randomized controlled trial of online cognitive behavioral therapy in addition to treatment-as-usual versus treatment-as-usual alone for adult patients with generalized anxiety disorder.
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067810
