UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022848
Receipt number R000026334
Scientific Title An open trial of the work support effect of group cognitive behacioral therapy for autistic spectrum disorders
Date of disclosure of the study information 2016/06/23
Last modified on 2019/09/26 09:26:50

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Basic information

Public title

An open trial of the work support effect of group cognitive behacioral therapy for autistic spectrum disorders

Acronym

An open trial of work support of CBT for ASD

Scientific Title

An open trial of the work support effect of group cognitive behacioral therapy for autistic spectrum disorders

Scientific Title:Acronym

An open trial of work support of CBT for ASD

Region

Japan


Condition

Condition

Autistic spectrum disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine work supporting effect of group cognitive behavioral therapy for patients with autistic spectrum disorders

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The change of total score of SFS-J between at the beginning and at the time of follow-up session

Key secondary outcomes

The change of each subscale of SFS-J, total score and each subscale of WHODAS2.0, total score and each subscale of LSAS-J, total score of BDI-II, total score of RSES-J between at the beginning and at the time of follow-up session
The change of total score and each subscale of SFS-J, total score and each subscale of WHODAS2.0, total score and each subscale of LSAS-J, total score of BDI-II, total score of RSES-J between at the beginning and at the end of therapy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A series of 12 sessions of group cognitive behavioral therapy

Interventions/Control_2


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

16 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

1. Autistic spectrum disorders defined by DSM-5
2. Outpatients of Chiba University Hospital
3. Age between 16 and 40

Key exclusion criteria

1. Incompetent
2. F0, F1 (excluding caffeine and nicotine), F2, F7 in ICD-10
3. Uncontrollable mental disorders other than above
4. Uncontrollable physical diseases
5. Having participated in other intervening clinical trials within three months
6. Suicidal attempts within one year
7. Prohibited by the doctor in charge

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Shiina

Organization

Center for Forensic Mental Health, Chiba University

Division name

Devision of Medical Treatment and Rehabilitation

Zip code

2608670

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken, Japan

TEL

043-222-7171

Email

shiina-akihiro@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Shiina

Organization

Center for Forensic Mental Health, Chiba University

Division name

Devision of Medical Treatment and Rehabilitation

Zip code

2608670

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken, Japan

TEL

043-222-7171

Homepage URL


Email

shiina-akihiro@faculty.chiba-u.jp


Sponsor or person

Institute

Devision of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University

Institute

Department

Personal name



Funding Source

Organization

The Japan Science Society

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Center of Chiba University Hospital

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken

Tel

043-222-7171

Email

chibacrc@mac.com


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

2016 Year 06 Month 23 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

26

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

2016 Year 06 Month 20 Day

Date of IRB

2016 Year 06 Month 26 Day

Anticipated trial start date

2016 Year 06 Month 26 Day

Last follow-up date

2019 Year 09 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 23 Day

Last modified on

2019 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name