UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009242
Receipt No. 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

* 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 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
Email 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
Email yoguchi1978@gmail.com

Sponsor
Institute i-CBT study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.