UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026355
Receipt number R000030278
Scientific Title Effects of cognitive behavior therapy offered by assertive community treatment team- a randomized control trial-
Date of disclosure of the study information 2017/03/05
Last modified on 2020/03/03 11:18:56

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Basic information

Public title

Effects of cognitive behavior therapy offered by assertive community treatment team- a randomized control trial-

Acronym

ACT&CBT study

Scientific Title

Effects of cognitive behavior therapy offered by assertive community treatment team- a randomized control trial-

Scientific Title:Acronym

ACT&CBT study

Region

Japan


Condition

Condition

Users of assertive community treatment who have difficulties in daily life caused by anxiety

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To exam effects of cognitive behavioral therapy provided by ACT staff in community settings using RCT design

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Anxiety assessed STAIY of ACT users at 12 months after from baseline

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

ACT with CBT

Interventions/Control_2

ACT only

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

ACT user
To have difficulties in daily life caused by anxiety

Key exclusion criteria

under 20 years of age
To be diagnosed with organic diseases or personality disorders

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Sayaka
Middle name
Last name Sato

Organization

National Institute of Mental Health,National Center of Neurology and Psychiatry

Division name

Department of Psychiatric Rehabilitation

Zip code

187-8553

Address

411 Ogawa higashi Kodaira Tokyo Japan

TEL

042-341-2711

Email

sayakas@ncnp.go.jp


Public contact

Name of contact person

1st name Sayaka
Middle name
Last name Sato

Organization

National Institute of Mental Health, National Center of Ne

Division name

Department of Psychiatric Rehabilitation

Zip code

187-8553

Address

411 Ogawa higashi Kodaira Tokyo Japan

TEL

042-341-2711

Homepage URL


Email

sayakas@ncnp.go.jp


Sponsor or person

Institute

Health, Labour and Welfare Ministry

Institute

Department

Personal name



Funding Source

Organization

Health, Labour and Welfare Ministry

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center of Neurology and Psychiatry

Address

4-1-1, Ogawa-higashi, Kodaira, Tokyo

Tel

042-341-2711

Email

sayakas@ncnp.go.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

2017 Year 03 Month 05 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

No longer recruiting

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2018 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

2017 Year 03 Month 01 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name