UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052377 |
|---|---|
| Receipt number | R000059794 |
| Scientific Title | Effect of cognitive behavior therapy for delayed phase (CBT-dp) on sleep problems and mental health in university students |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2023/10/02 17:49:34 |
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Basic information
Public title
Effect of cognitive behavior therapy for delayed phase (CBT-dp) on sleep problems and mental health in university students
Acronym
Effect of cognitive behavior therapy for delayed phase (CBT-dp) on sleep problems and mental health in university students
Scientific Title
Effect of cognitive behavior therapy for delayed phase (CBT-dp) on sleep problems and mental health in university students
Scientific Title:Acronym
Effect of cognitive behavior therapy for delayed phase (CBT-dp) on sleep problems and mental health in university students
Region
| Japan |
Condition
Condition
Delayed Sleep-Wake Phase Disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is examine to develop a cognitive-behavioral therapy for delayed sleep-wake phase (CBT-dp) in adolescents in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athen Insomnia Scale (AIS)
Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN)
Epworth Sleepiness Scale (ESS)
Key secondary outcomes
K6
subjective sleep variable (Sleep diary)
objective sleep variable (Actigraph)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral therapy for delayed phase (CBT-dp) including bright-light therapy
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Individuals whose BRIAN score is 41 points or higher
(2) Individuals who currently enrolled in a university
Key exclusion criteria
Individuals with a history of mental health clinic visits.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei Univeristy
Division name
Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5276
okajima-i@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei Univeristy
Division name
Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5276
Homepage URL
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei Univeristy
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei Univeristy
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
Tokyo Kasei Univeristy
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
03-3961-5276
okajima-i@tokyo-kasei.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
It was revealed the AIS (Hedges' g=4.16 [post], 1.89 [FU]), BRIAN (g=1.24, 0.51), and ESS (g=4.34, 1.13) were significantly reduced from pre-intervention to post-intervention and 1-month follow-up period. Although K6 was not significantly different, effect size after intervention was large at post-intervention (g=3.05, 0.26).
Results date posted
| 2023 | Year | 10 | Month | 02 | Day |
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
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059794
