UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015591 |
|---|---|
| Receipt number | R000018111 |
| Scientific Title | A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression |
| Date of disclosure of the study information | 2014/11/03 |
| Last modified on | 2016/11/14 09:34:27 |
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Basic information
Public title
A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Acronym
P-iCBT Study
Scientific Title
A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Scientific Title:Acronym
P-iCBT Study
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To assess the clinical- and cost- effectiveness of P-iCBT on Japanese adults with depression as compared to standalone iCBT or waiting list
2)To assess the validity and reliability of a smartphone-app for the Autonomic Nervous System's Imbalance Index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Beck Depression Inventory-2 (BDI-2)
Japanese Version
2)The Autonomic Nervous System's
Imbalance Index
Key secondary outcomes
1)
1-1) K6 Japanese Version
1-2) STAI Japanese Version
1-3) SF-12v2 Japanese Version
2) Medical Costs
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Weekly self-help intervention by standalone iCBT over seven weeks
Interventions/Control_2
Weekly self-help intervention by peer-enhanced iCBT over seven weeks
Interventions/Control_3
Wait-list over seven weeks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Regular access to the Internet
2) A score of 5 or more on the PHQ-9
3) Ability to both understand and agree
with informed consent in Japanese
4) Availability of iPhone, iPad or iPod
touch,regardless of its ownership, at
three assessment points
Key exclusion criteria
1) Receiving any other CBT intervention
during the trial
2) A score of 21 or more on the PHQ-9
3) Strong suicidal ideation
4) Schizophrenia
5) Dementia
6) Any substance addiction (except
nicotine addiction) during the 12
months prior to the trial
7) (For patients receiving treatment by a
mental health practitioner)
Unavailability of practitioner's
permission for the patient to
participate in the trial
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mirai So |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-(0)3-3353-1211
mirai.so@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mirai So |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-(0)3-3353-1211
Homepage URL
mirai.so@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Society for the Promotion of Science
Grant-in-Aid for Scientific Research (26350862)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Wellness and Ecological Sciences (Global Research Center for Applied System Science)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 11 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 03 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018111
