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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026355
Receipt No. 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 2018/09/01

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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
Middle name
Last name Sayaka Sato
Organization National Institute of Mental Health,National Center of Neurology and Psychiatry
Division name Department of Psychiatric Rehabilitation
Zip code
Address 411 Ogawa higashi Kodaira Tokyo Japan
TEL 042-341-2711
Email sayakas@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Sato
Organization National Institute of Mental Health, National Center of Ne
Division name Department of Psychiatric Rehabilitation
Zip code
Address 411 Ogawa higashi Kodaira Tokyo Japan
TEL 042-341-2711
Homepage URL
Email sayakas@ncnp.go.jp

Sponsor
Institute Health, Labour and Welfare Ministry
Institute
Department

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
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

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
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.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


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