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 |
* 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
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
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
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
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
