UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Self-Care Combined Auricular Therapy and Cognitive Behavioral Therapy on Sleep, Mentality, and Learning in College Students
Acronym	Effects of Self-Care Combined Auricular Therapy and Cognitive Behavioral Therapy on Sleep, Mentality, and Learning in College Students
Scientific Title	Effects of Self-Care Combined Auricular Therapy and Cognitive Behavioral Therapy on Sleep, Mentality, and Learning in College Students
Scientific Title:Acronym	Effects of Self-Care Combined Auricular Therapy and Cognitive Behavioral Therapy on Sleep, Mentality, and Learning in College Students
Region	Japan

Condition
Condition	Persons with sleep problems
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the efficacy and sustainability of ICBT and auricular therapy combined self-care on sleep, mental health, and motivation to learn in college students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Insomnia Severity Scale (ISI)
Key secondary outcomes	Sleep diary, Pittsburgh Sleep Questionnaire (PSQI), sleepiness scale (ESS), Sleep Attitudes Survey (DBAS), mental status on the Depression Scale (PHQ-9), student version of the Utrecht Work Engagement Scale (UWESS) for learning motivation, autonomic nervous activity during sleep

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	Device,equipment
Interventions/Control_1	cognitive behavioral therapy
Interventions/Control_2	auricular therapy
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	1. Those who have no apparent organic disease on physical examination. 2. Those with an Insomnia Severity Index (ISI) of 8 or more points.
Key exclusion criteria	1. Those who are receiving hospitalization or medication 2. Those who are participating in other clinical trials or clinical studies at the same time 3. Those who live day and night in reverse due to work or part-time job.
Target sample size	142

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Waki
Organization	University of Teikyoheise Faculty of Health Care
Division name	Department of acupuncture and Moxibustion.
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL	035-843-3111
Email	h.waki@thu.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Waki
Organization	University of Teikyoheise Faculty of Health Care
Division name	Department of acupuncture and Moxibustion.
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL	035-843-3111
Homepage URL
Email	h.waki@thu.ac.jp

Sponsor
Institute	Teikyo Heisei University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
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	Teikyo Heisei University
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo 170-8445, Japan
Tel	03-5843-3111
Email	rec@thu.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	2022 Year 11 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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 01 Day
Date of IRB	2022 Year 09 Month 13 Day
Anticipated trial start date	2022 Year 10 Month 06 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	2022 Year 10 Month 07 Day
Last modified on	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055998