UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049007 |
|---|---|
| Receipt number | R000055405 |
| Scientific Title | Effects of psychophysiological intervention for generalized anxiety disorder on the alteration of clinical symptoms and social dysfunction and their mechanisms of change |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2024/03/27 16:10:06 |
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Basic information
Public title
Effects of intervention for anxiety disorder on the alteration of symptoms and daily life impairments
Acronym
Effects of intervention for anxiety disorder on the alteration of daily life impairments
Scientific Title
Effects of psychophysiological intervention for generalized anxiety disorder on the alteration of clinical symptoms and social dysfunction and their mechanisms of change
Scientific Title:Acronym
Effects of intervention for generalized anxiety disorder on the alteration of social dysfunction
Region
| Japan |
Condition
Condition
Generalized Anxiety Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and mechanism of action of metacognitive therapy for social dysfunction in generalized anxiety disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sheehan Disability Scale (SDISS) and Generalized Anxiety Disorder 7 Scale (GAD-7) six weeks after, and 3 months after the post of the intervention
Key secondary outcomes
1). Patient Health Questionnaire 9 (PHQ-9) six weeks after, and 3 months after the post of the intervention
2). Penn State Worry Questionnaire (PSWQ) six weeks after, and 3 months after the start of the intervention
3). Social function items on the Ecological Momentary Assessment one week after the intake session and two weeks after the last session
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Six-week online individualized metacognitive therapy, and 3-month follow-up session
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who meet generalized anxiety disorder criteria on both Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) and Mini-International Neuropsychiatric Interview (M.I.N.I.), and showed symptoms of both PSWQ (56 points or more) and SDISS (7 points or more).
Key exclusion criteria
-Those who have problems in reading and writing Japanese.
-Patients with a history of heart disease or diabetes mellitus
-Smoking habit on a daily basis.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
jtayama@waseda.jp
Public contact
Name of contact person
| 1st name | Minori |
| Middle name | |
| Last name | Machida |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
090-1797-0059
Homepage URL
m.machida@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
The Institute of Seizon and Life Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
-Stress Care Tokyo Ueno Ekimae Clinic
-TechDoctor, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research with Hu man Subjects of Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo, 169-8 050, JAPAN
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学（埼玉県），ストレスケア東京上野駅前クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055405
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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