UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053430 |
|---|---|
| Receipt number | R000060977 |
| Scientific Title | Developing resilience through rumination-focused cognitive-behavior therapy self-help in female university students: Randomized controlled trial |
| Date of disclosure of the study information | 2024/01/29 |
| Last modified on | 2024/01/31 22:11:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Resilience through Emotional Support for University Mental well-being and Empowerment through CBT
Acronym
RESUME
Scientific Title
Developing resilience through rumination-focused cognitive-behavior therapy self-help in female university students: Randomized controlled trial
Scientific Title:Acronym
RESUME
Region
| Japan |
Condition
Condition
repetitive negative thoughts (rumination, worry), depression, anxiety
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Repetitive negative thoughts (RNT) such as rumination and worry are an important risk factor for depression and anxiety. A self-help programme based on rumination-focused cognitive-behavioural therapy aims to prevent depression and anxiety and develop resilience by reducing RNT in Japanese female university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Ruminative Responses Scale
Key secondary outcomes
Penn State Worry Questionnaire, PHQ-9, GAD-7
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will receive an RFCBT self-help programme. RFCBT is a form of CBT that applies functional analysis, and aims to reduce RNT through modules such as self-monitoring of RNT, concrete thinking, compassion, and absorption exercises.
Interventions/Control_2
The control is a waitlist group. After pre/post measurement, participants are asked whether they would prefer receiving RFCBT self-help programme.
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
High ruminators/worriers, as measured by the RRS (scoring 55 or higher; Hasegawa, 2013) and PSWQ (scoring 64 or higher; Sugiura & Tanno, 2000)
Key exclusion criteria
(a) Students with high depression (scoring 22 or higher on PHQ-9; Inoue et al., 2012), or those who responded 2 (more than half the days) or higher to PHQ-9 item 9 (suicidal ideation); (b) Those who are receiving regular psychiatric treatment or counseling
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Umegaki |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
630-8506
Address
Kita-Uoya-Nishi-Machi, Nara City, Nara
TEL
0742203577
y.umegaki@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Umegaki |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
630-8506
Address
Kita-Uoya-Nishi-Machi, Nara City, Nara
TEL
0742203577
Homepage URL
y.umegaki@cc.nara-wu.ac.jp
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
Yusuke Umegaki
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Other
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 Human Subjects, Nara Women's University
Address
Higashi-machi Kitauoya, Nara-city, Nara
Tel
0742-20-3762
kenkyou@cc.nara-wu.ac.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
奈良女子大学（奈良県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2028 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060977
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
