UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055083 |
|---|---|
| Receipt number | R000062925 |
| Scientific Title | Effectiveness of a Cognitive Behavioral Changes Program for Subthreshold Depression in Perimenopausal Women |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/07/26 12:43:34 |
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Basic information
Public title
Effectiveness of a Cognitive Behavioral Changes Program for Subclinical Depression in Perimenopausal Women
Acronym
Effectiveness of a Cognitive Behavioral Changes Program in Perimenopausal Women
Scientific Title
Effectiveness of a Cognitive Behavioral Changes Program for Subthreshold Depression in Perimenopausal Women
Scientific Title:Acronym
Effectiveness of a Cognitive Behavioral Changes Program for Subthreshold Depression in Perimenopausal Women
Region
| Japan |
Condition
Condition
Subthreshold Depression in Perimenopausal Women
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a web-based psychoeducational program designed to promote cognitive and behavioral changes in women experiencing menopausal depression and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menopause Symptom Coping Scale (27 items)
Key secondary outcomes
-Patient Health Questionnaire-9 (PHQ-9) (9 items)
-Generalized Anxiety Disorder-7 (GAD-7) (7 items)
-Simplified Menopausal Index (SMI) (10 items)
-Satisfaction (Anchor Question) (1 item)
-Japanese version of the Ten Item Personality Inventory (TIPI-J)
-Motivational Ruler (2 items)
-Satisfaction (Usability of the App, Content Satisfaction) (2 items)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A web-based psychological education program aimed at promoting cognitive and behavioral changes will be conducted five days a week for four weeks, totaling 20 sessions.
Interventions/Control_2
While the web-based psychoeducational program aimed at promoting cognitive and behavioral changes was not implemented, participants were asked to complete a survey at both the beginning and end of the study.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Women aged between 40 and 59 years (broadly defined as the perimenopausal period, during which various symptoms or discomforts may begin to appear).
2.Individuals who have never sought medical consultation or been diagnosed for depression.
3.Individuals who have access to the internet via a computer, smartphone, or tablet.
4.Native speakers of Japanese who can understand explanations in Japanese and provide online consent of their own free will.
Key exclusion criteria
Individuals currently receiving outpatient psychiatric care.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Numata |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2027
n_numata@chiba-u.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Numata |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2027
Homepage URL
n_numata@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba 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
Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
043-226-2027
n_numata@chiba-u.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 | 01 | 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 | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 17 | 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 | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062925
