UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055435 |
|---|---|
| Receipt number | R000058691 |
| Scientific Title | The impact of cognitive behavioral therapy for sleep on the development of psychological and physical problems in college athletes. |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/05 21:33:24 |
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Basic information
Public title
The impact of cognitive behavioral therapy for sleep on the development of psychological and physical problems in college athletes.
Acronym
The impact of cognitive behavioral therapy for sleep on the condition of college athletes
Scientific Title
The impact of cognitive behavioral therapy for sleep on the development of psychological and physical problems in college athletes.
Scientific Title:Acronym
The impact of cognitive behavioral therapy for sleep on the condition of college athletes
Region
| Japan |
Condition
Condition
College athletes with sleep problems
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of CBT for college athletes with sleep problems on the condition of the athlete, including sleep and physical psychological problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index(PSQI)
Key secondary outcomes
Questionnaire on history of injury in the past year and presence and severity of current injury
Athlete Psychological Strain Questionnaire (APSQ)
Melatonin metabolites in urine
Oslo Sports Trauma Research Center questionnaires(OSTRC-H2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy
Interventions/Control_2
No treatment
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Those who have no obvious organic diseases on physical examination
(ii) College athletes who belong to a national collegiate athletic association and are active as an athlete
(iii) Those with a Pittsburgh Sleep Quality Index (PSQI) score of 6 or higher
Key exclusion criteria
(i) Those who are receiving hospitalization or medication
(ii) Those who are participating in other clinical trials or clinical studies at the same time
(iii) Those who live day and night in reverse due to work or part-time job.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
TEL
048-471-7549
naruto-y-ad@rikkyo.ac.jp
Public contact
Name of contact person
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
TEL
048-471-7549
Homepage URL
naruto-y-ad@rikkyo.ac.jp
Sponsor or person
Institute
Rikkyo University
Institute
Department
Personal name
Funding Source
Organization
Rikkyo 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
Rikkyo University
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
Tel
048-471-7549
naruto-y-ad@rikkyo.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
| 2024 | Year | 09 | Month | 30 | 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 | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2026 | 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 | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058691
