UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055495 |
|---|---|
| Receipt number | R000063413 |
| Scientific Title | Examining the Effects of Attention Bias Training Method on Physical Activity in Depression-prone Individuals |
| Date of disclosure of the study information | 2024/09/13 |
| Last modified on | 2025/01/10 15:16:12 |
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Basic information
Public title
Examining the Effects of Attention Bias Training Method on Physical Activity in Depression-prone Individuals
Acronym
Examining the Effects of Attention Bias Training Method on Physical Activity in Depression-prone Individuals
Scientific Title
Examining the Effects of Attention Bias Training Method on Physical Activity in Depression-prone Individuals
Scientific Title:Acronym
Examining the Effects of Attention Bias Training Method on Physical Activity in Depression-prone Individuals
Region
| Japan |
Condition
Condition
subclinical depression
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of the Attention Bias Training Method (ABM) on physical activity in depressed individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Physical Activity Questionnaire(IPAQ) short version Japanese version
Key secondary outcomes
The Center for Epidemiologic Studies Depression Scale Japanese version
Profile of Mood States 2nd Edition Adult Short Japanese version
Number of steps
Physical Status Questionnaire (used only for (7))
Exercise Decision-Making Balance Scale
Exercise Self-Effectiveness Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implement Attention Bias Modification twice a day for two weeks.
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Must be a university or graduate student.
2. Must not have engaged in physical activity for more than 30 minutes at least twice a week over the past month.
3. Must have a CES-D score between 16 and 25.
4. Must be between 18 and 45 years old.
Key exclusion criteria
1. Individuals who currently have an illness or injury.
2. Individuals currently undergoing pharmacotherapy for a psychiatric disorder.
3. Individuals experiencing severe fatigue or lack of sleep.
4. Individuals currently receiving or with past experience in psychotherapy or counseling.
5. Individuals who have recently experienced a traumatic event.
6. Individuals currently participating in other experiments that span multiple days.
Target sample size
20
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,359-1192, Japan
TEL
+81-4-2947-6849
yuiyuimisato@ruri.waseda.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Aoki |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192, Japan
TEL
+81-4-2947-6849
Homepage URL
yuiyuimisato@ruri.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
Waseda University Ethical Review Committee concerning Research with Human Subjects
Address
1-104, Totsuka, Shinjuku, Tokyo, 169-8050, 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 | 09 | Month | 13 | 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 | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | 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 | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063413
