UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052148 |
|---|---|
| Receipt number | R000059517 |
| Scientific Title | Effects of Different Types of Use of Computerized Cognitive Behavioral Therapy (SPARX) on Improvement of Depressive Symptoms in College Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/09/09 |
| Last modified on | 2023/09/07 23:26:34 |
* 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
Examining differences in effectiveness of cognitive behavioral therapy apps depending on the type of use.
Acronym
Effectiveness of Cognitive Behavioral Therapy Apps
Scientific Title
Effects of Different Types of Use of Computerized Cognitive Behavioral Therapy (SPARX) on Improvement of Depressive Symptoms in College Students: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Computerized Cognitive Behavioral Therapy by Type of Use
Region
| Japan |
Condition
Condition
Depressive symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the effects of differences in the use of computer-based cognitive-behavioral therapy (SPARX) on depressive symptoms in college students. Specifically, the study will examine whether the use of SPARX at one's own pace in daily life is effective in improving depressive symptoms through a randomized controlled trial, by comparing the use of SPARX with professional support, completely non-face-to-face (use at one's own pace), and a wait-and-see control group. In addition, usability data obtained through the study will be used to identify more effective ways to use SPARX.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Depressive symptoms
Key secondary outcomes
Well-being, mood states, health-related quality of life, rumination, cognitive behavioral therapy skills
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Seven weeks of professionally guided computerized cognitive behavioral therapy
Interventions/Control_2
Seven weeks of computerized cognitive behavioral therapy
Interventions/Control_3
Waiting-list
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Depressive symptoms are moderate or more (10 <= PHQ-9)
Gives full informed consent to participate in the study
Key exclusion criteria
Experience using the SPARX
Other relevant reason as determined by the researchers
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mayu |
| Middle name | |
| Last name | Sekiguchi |
Organization
Health Science of University Hokkaido
Division name
Department of Clinical Psychology
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido
TEL
0133-23-1211
sekiguchi@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Sekiguchi |
Organization
Health Science of University Hokkaido
Division name
Department of Clinical Psychology
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido
TEL
0133-23-1211
Homepage URL
sekiguchi@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Science of University Hokkaido
Institute
Department
Personal name
Mayu Sekiguchi
Funding Source
Organization
KDDI Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Medical University
University of Human Environments
Hokusho University
HIKARI Lab CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Science of University Hokkaido
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido
Tel
0133-23-1211
sekiguchi@hoku-iryo-u.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 | 09 | Month | 09 | 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
81
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059517
