UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043685 |
|---|---|
| Receipt number | 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 | 2023/10/02 18:09:08 |
* 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
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
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
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei Univeristy
Institute
Department
Personal name
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
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
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
Completed
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
| 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=R000049883
