UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053893 |
|---|---|
| Receipt number | R000061439 |
| Scientific Title | Comparative Effects of Differential Metacognition and Attention Manipulation on Effects and Mechanism of Change for Social Dysfunction in High Worriers on University Students in Japan. |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/10/21 20:56:20 |
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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 for anxiety and life impairment.
Scientific Title
Comparative Effects of Differential Metacognition and Attention Manipulation on Effects and Mechanism of Change for Social Dysfunction in High Worriers on University Students in Japan.
Scientific Title:Acronym
Investigation of the Mechanism of Change of Metacognition and Attention Manipulation on Social Dysfunction in High Worriers.
Region
| Japan |
Condition
Condition
High Worrier
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By manipulating variables that are hypothesized to be associated with social dysfunction and symptom change in high worriers who exhibit clinically meaningful levels of worry and social dysfunction, we will examine the associations between these target variables and social dysfunction and symptom change and identify processes controlling social dysfunction and symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
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
Classification of the percentage of subjects achieving functional and/or symptomatic resolution at the end of the intervention period (post) and 3 months later (follow-up):
(1) Recovery: Sheehan Disability Scale (SDS) scores below the remission criteria (<= 6) and Penn State Worry Questionnaire (PSWQ) scores below remission criteria (<= 47)
(2) Functional remission only: Sheehan Disability Scale score below the cutoff (<= 6)
(3) Symptomatic remission only (improvement): Percentage of person achieving symptomatic remission criteria and clinically significant change on the PSWQ (>= 7 points reduction and final score on PSWQ <= 47)
Ecological Momentary Assessment-social function items change between Baseline term (1 week before intervention start) to Post term (1 week later of the end of intervention term).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A total of three sessions of online intervention, one session per week, will be conducted on the following topics
Session 1: Implement psychoeducation targeting attentional control abilities and seek to implement Attention Training Technique twice a day as homework targeting the same subject.
Session 2: Psychoeducation targeting negative metacognitive beliefs about worry will be conducted and homework targeting the same subjects will involve conducting the Self-Instruction Training.
Session 3: Implement psychoeducation targeting constructive attentional strategies. Also, seek to implement the Situational Attentional Refocusing as homework targeting similar targets.
Interventions/Control_2
A total of three sessions of online intervention, one session per week, will be conducted on the following topics
Session 1: Implement psychoeducation targeting attentional control abilities and seek to implement Attention Training Technique twice a day as homework targeting the same subject.
Session 2: Psychoeducation targeting negative metacognitive beliefs about worry will be conducted and homework targeting the same subjects will involve conducting the Worry Postponement Experiment and the Loss of Control Experiment.
Session 3: Only sharing of the past week's homework will be conducted.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Undergraduate or graduate students attending a university in Japan.
(2) Score 56 or higher on the Penn State Worry Questionnaire (Mayer et al., 1999), which is the standard for high worriers.
(3) Score 7 or higher on the Sheehan Disability Scale (Sheehan et al., 2008), which is the standard for clinically meaningful social dysfunction.
Key exclusion criteria
(1) Currently receiving support for mental health problems at a medical institution or other counseling facility.
(2) Have difficulty in reading and writing Japanese.
Target sample size
40
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
Machida Minori
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 | 03 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 18 | 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=R000061439
