UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048990 |
|---|---|
| Receipt number | R000055763 |
| Scientific Title | Effects and mechanisms of change during metacognitive interventions for anxiety and social dysfunction in high worrier |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2023/08/27 08:39:22 |
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Basic information
Public title
Effects and mechanisms of change during psychological techniques for anxiety and life impairment
Acronym
Mechanisms of change during psychological techniques for anxiety and life impairment
Scientific Title
Effects and mechanisms of change during metacognitive interventions for anxiety and social dysfunction in high worrier
Scientific Title:Acronym
Mechanisms of change during metacognitive interventions for anxiety and social dysfunction in high worrier
Region
| Japan |
Condition
Condition
Undergraduate and graduate students who met the criteria of high worry and social dysfuntion
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the differences in efficacy and mechanisms of action between two metacognitive interventions for undergraduate and graduate students who present clinically meaningful levels of social dysfunction among those under the diagnostic threshold who present with psychosocial difficulties comparable to those of patients with generalized anxiety (high worriers), and a wait-list control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At Post point (i.e., end of intervention) and Follow-up point which is 3 months later of Post point: (1) Sheehan Disability Scale, (2) Generalized Anxiety Disorder-7, (3) Patient Health Questionnaire-9
Key secondary outcomes
-(1) percentage of Sheehan Disability Scale under 6points, (2) percentage of Penn State Worry Questionnaire (PSWQ) under 47points, (3) percentage of 7point decrease and PSWQ over 48points
-Ecological Momentary Assessment-social function items change between Baseline (3 days before intervention start) to Post (3 days later of the end of intervention term)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Group 1: 2 session intervention for metacognitive beliefs, attention control, executive processing, and attentional strategies which is based on metacognitive therapy
Interventions/Control_2
Group 2: 2 session intervention for metacognitive beliefs and attention control which is based on metacognitive therapy
Interventions/Control_3
Group 3: Waitlist control
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Undergraduate and graduate students who belong to Japanese university
-Penn State Worry Questionnaire over 56points
-Sheehan Disability Scale over 7points
Key exclusion criteria
-Has difficulty of reading and writing Japanese
-Who experienced psychiatric or psychosomatic treatment, including medication, psychotherapy, or psychological counseling in past or current
-Has a history of heart disease or diabetes
-Smoking habit on a daily basis.
Target sample size
60
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
Mikajima
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
Mikajima
TEL
09017970059
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
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | 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 | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055763
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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