UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055904 |
|---|---|
| Receipt number | R000063877 |
| Scientific Title | Psychophysiological study of attentional process for high worriers |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2024/10/21 20:28:43 |
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Basic information
Public title
Experimental study about attentional process for worriers
Acronym
Study of attentional process for worriers
Scientific Title
Psychophysiological study of attentional process for high worriers
Scientific Title:Acronym
Experimental study of attentional process for high worriers
Region
| Japan |
Condition
Condition
high worriers
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to compare the difference of effects and mechanism of change for clinical symptoms and social dysfunctions in high worriers during using virtual reality or not when manipulating constructive attentional strategies based on metacognitive therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a). Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
b). Social functions measurements for ecological momentary assessment (SF_EMA; Machida et al., 2023)
Key secondary outcomes
a). Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990)
b). Generalized Anxiety Disorder 7 Scale (GAD-7; Spitzer et al., 2006)
c). Patient Health Questionnaire 9 Scale (PHQ-9; Kroenke et al., 2001)
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
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
SAR+ATT group:
Former intervention week: First day, they will participate psychoeducation in online. They will do Attention Training Technique (ATT) two times per day as homework.
Later intervention week: First day, they will participate psychoeducation at experiment room. They will practice constructive attentional strategies to use threat stimuli which role common threat stimuli for generalized anxiety disorder (GAD) as a roleplaying. They will do Situational Attentional Refocusing (SAR) in daily situations as homework.
Interventions/Control_2
SAR group:
Former intervention week: First day, they will participate psychoeducation at experiment room. They will practice constructive attentional strategies to use threat stimuli which role common threat stimuli for GAD as a roleplaying. They will do SAR in daily situations as homework.
Later intervention week: They will do SAR in daily situations as homework.
Interventions/Control_3
ATT group:
Former intervention week: First day, they will participate psychoeducation in online. They will do Attention Training Technique (ATT) two times per day as homework.
Later intervention week: They will do Attention Training Technique (ATT) two times per day as homework.
Interventions/Control_4
WLC group:
They will nothing do interventions.
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
(a) undergraduate or graduate students in Japan
(b) fifty six or over for PSWQ score (i.e., high worriers; Ruscio, 2002)
Key exclusion criteria
(a) difficult to reading and writing Japanese
(b) now participating anything psychotherapy at psychiatry or psychosomatic medicine
(c) suffering from claustrophobia
(d) use of benzodiazepines
(e) suffering from any of the following health issues: diseases related to the inner ear or vestibular system, cardiovascular diseases or circulatory disorders, migraines, blood pressure disorders or diabetes
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
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6756
jtayama@waseda.jp
Public contact
Name of contact person
| 1st name | Minori |
| Middle name | |
| Last name | Machida |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6756
Homepage URL
m.machida@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects in Waseda University
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 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
| 2024 | Year | 10 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063877
