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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000043685
Receipt No. R000049883
Scientific Title Effect of email-delivered CBT-I on insomnia, anxiety, and depression for young adults: a randomized controlled trial
Date of disclosure of the study information 2021/03/20
Last modified on 2021/03/20

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Basic information
Public title Effect of email-delivered CBT-I on insomnia, anxiety, and depression for young adults: a randomized controlled trial
Acronym Effect of email-delivered CBT-I on insomnia, anxiety, and depression for young adults: a randomized controlled trial
Scientific Title Effect of email-delivered CBT-I on insomnia, anxiety, and depression for young adults: a randomized controlled trial
Scientific Title:Acronym Effect of email-delivered CBT-I on insomnia, anxiety, and depression for young adults: a randomized controlled trial
Region
Japan

Condition
Condition insomnia
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to examine the effects of an e-mail delivered CBT-I program, which is fully-packaged CBT components, on insomnia severity, affective symptoms such as depression, and insomnia-related symptoms for college students with insomnia, compared with self-monitoring group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Insomnia Severity Index (ISI), Depression Anxiety Stress Scale (DASS)
Key secondary outcomes Sleep Hygiene Practice Scale (SHPS), Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16), The Ford Insomnia Response to Stress Test (FIRST), The Pre-Sleep Arousal Scale (PSAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Eight weekly sessions of e-mail delivered CBT-I (REFRESH)
Interventions/Control_2 Self-monitoring (sleep diary) (SM)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) university students, (2) a total score of ISI was greater than 10 or more (a psychopathological cut-off point for Japanese version of the ISI).
Key exclusion criteria (1) current or past medical history of mental disorders such as bipolar disorders, schizophrenia spectrum disorders.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name ISA
Middle name
Last name Okajima
Organization Tokyo Kasei University
Division name Department of Psychological Counseling
Zip code 176-8602
Address 1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3961-5276
Email okajima-i@tokyo-kasei.ac.jp

Public contact
Name of contact person
1st name Isa
Middle name
Last name Okajima
Organization Tokyo Kasei University
Division name Department of Psychological Counseling
Zip code 176-8602
Address 1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3961-5276
Homepage URL
Email okajima-i@tokyo-kasei.ac.jp

Sponsor
Institute Tokyo Kasei Univeristy
Institute
Department

Funding Source
Organization JSPS
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Kasei University
Address 1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel 03-3961-5276
Email isa.okajima@gmail.com

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
2021 Year 03 Month 20 Day

Related information
URL releasing protocol https://www.sciencedirect.com/science/article/abs/pii/S138994571931161X?via%3Dihub
Publication of results Partially published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/abs/pii/S138994571931161X?via%3Dihub
Number of participants that the trial has enrolled 48
Results The results of analysis using mixed-effect model for repeated measures showed a significant effect of interaction for the ISI, DASS-depression, and DASS-anxiety scores (p < 0.005). In the results of the post-hoc test, the REFRESH group significantly improved on these symptoms at the post-intervention period, compared with the self-monitoring group (p < 0.05). In addition, these score significantly improved from pre- to post-intervention in the REFRESH group (p < 0.05).
Results date posted
2021 Year 03 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Forty-eight of young adults (67% female, 19.56 [SD=1.86] years)
Participant flow (1)We recruited participants via advertising on university campus in Japan.
(2)One hundred and twenty-nine students completed an informed consent form and online questionnaires.
(3)Choosing the participants besed on the inclusion and exclusion criteria
(4) Forty-eight of them were randomly assigned to either the REFRESH group (n=24) or a SM group
Adverse events none
Outcome measures ISI, DASS-21, SHPS, DBAS-16, FIRST, PSAS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2017 Year 11 Month 09 Day
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 07 Month 01 Day
Date analysis concluded
2019 Year 07 Month 25 Day

Other
Other related information

Management information
Registered date
2021 Year 03 Month 20 Day
Last modified on
2021 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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