UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009242 |
|---|---|
| Receipt number | R000010852 |
| Scientific Title | A randomized controlled trial of internet-assisted Cognitive Behavioral Therapy for depression |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2016/10/14 18:52:23 |
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Basic information
Public title
A randomized controlled trial of internet-assisted Cognitive Behavioral Therapy for depression
Acronym
i-CBT Study
Scientific Title
A randomized controlled trial of internet-assisted Cognitive Behavioral Therapy for depression
Scientific Title:Acronym
i-CBT Study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the internet-assisted cognitive behavior therapy with waiting-list control group in adult patients with moderate major depression (Hamilton-Depression Scale17-items(HAMD-17)>=14) who had received adequate one antidepressant trial at least 6weeks at study entry.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Hamilton Depression Rating Scale (HAMD-17) score at endpoint will be compared between the groups
Key secondary outcomes
Response rate(defined as 50% reduction of baseline HAMD-17),remission rate(defined as HAMD=<7),subjective depression(measured with the BDI and QIDS),quality of life(measured with EQ-5D and SF-36) and vulnerability measure of depression and cognition (DAS) at 12week and post-intervention phase(up to 6months) will be compared between the groups.Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups.
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
internet-assisted cognitive behavior therapy in addition to treatment as usual
Interventions/Control_2
treatment as usual
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects with current DSM-IV Major Depressive Disorder based on SCID at screening.
2.Subjects with HAMD-17 score>=14 at screening.
3.Subjects who had received at least adequate one trial of antidepressant therapy for more than 6weeks.
4.Aged 20 years or older, and younger than 65 years at screening.
5.Subjects who give full consent in the participation of the study.
6.Subjects who can be used to use the internet.
7.Subjects who have the possibility that they can go to the hospital more than 6 times during the study period.
Key exclusion criteria
1.No alcohol or substance use disorder in 6 months prior to the screening.
2.No history or concurrent manic or psychotic episode.
3.No other primary DSM-IV Axis I Disorders at screening.
4.No comorbid of antisocial personality disorder.
5.No serious suicidal ideation at screening.
6.No past treatment of individual CBT.
7.No organic brain lesions or major cognitive deficits in a year prior to the screening.
8.No severe or unstable medical co-morbidities at screening.
9.Other relevant reason decided by the i-CBT principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Nakagawa, MD, PhD |
Organization
National Center of Neurology & Psychiatry
Division name
Translational Medical Center/CBT Center
Zip code
Address
Ogawahigashi-cho 4-1-1, Kodaira-shi Tokyo 187-8551, Japan
TEL
042-341-2711
anakagawa@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyo Oguchi |
Organization
National Center of Neurology & Psychiatry
Division name
CBT Center
Zip code
Address
Ogawahigashi-cho 4-1-1, Kodaira-shi Tokyo 187-8551, Japan
TEL
042-341-2711
Homepage URL
yoguchi1978@gmail.com
Sponsor or person
Institute
i-CBT study group
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry Intramural Grant Aid
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
慶應義塾大学医学部（東京都）
独立行政法人国立病院機構東京医療センター（東京都）
桜ヶ丘記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 14 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 01 | Day |
Last modified on
| 2016 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852
