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

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 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


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

Value
https://center6.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