UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012344
Receipt number R000014436
Scientific Title Intervention study of cognitive behavioral therapy program for patients with substance use disorder and other mental disorders
Date of disclosure of the study information 2013/11/19
Last modified on 2017/03/02 10:53:10

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Basic information

Public title

Intervention study of cognitive behavioral therapy program for patients with substance use disorder and other mental disorders

Acronym

Intervention study of cognitive behavioral therapy program for substance use disorder

Scientific Title

Intervention study of cognitive behavioral therapy program for patients with substance use disorder and other mental disorders

Scientific Title:Acronym

Intervention study of cognitive behavioral therapy program for substance use disorder

Region

Japan


Condition

Condition

Substance Use Disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of cognitive behavioral therapy program for patients with substance use disorder

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

psychological changes
Brief Psychiatric Rating Scale(BPRS)
Schedule for Assessment of Insight(SAI-J)
Global Assessment of Functioning Scale (GAF)

Key secondary outcomes

1. Social situation (before start Program)
Alcohol Use Disorders Identification Test(AUDIT)
Drug Abuse Screening Test(DAST)
2.Changes of thinking for substance use (DRUG ATTITUDE INVENTORY, DAI-10)
General Self-Efficacy Scale(GSES)
Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
3. Impression for used program


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

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

cognitive behavioral therapy program

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. In patients at Showa University Karasuyama Hospital
2. Patients who diagnosed as follows by ICD-10
F1
doubled diagnosed with other mental disorder such as F2, F3
F1x.5 or F1x.7
3. Mentally stable judged by the investigator
4. No other serious psychological and physical complication
5. Patients who understand the content of the study

Key exclusion criteria

1. Patients who are inadequate for treatment judged by the investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junko Inamoto

Organization

Showa University

Division name

School of Medicine, Department of Psychiatry

Zip code


Address

6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo 157-8577

TEL

03-3300-5232

Email

atsuko_inamoto@excite.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Ikeda

Organization

Showa University

Division name

School of Medicine, Department of Psychiatry

Zip code


Address

6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo 157-8577

TEL

03-3300-5231

Homepage URL


Email

t.ikeda@cmed.showa-u.ac.jp


Sponsor or person

Institute

Department of Psychiatry Showa University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Mitsubishi Foundation, Grants for Social Welfare Activities

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

none


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

昭和大学附属烏山病院


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Japanese Bulletin of Social Psychiatry 26:11-24,2017
The results revealed that these individuals had difficult backgrounds, including a high rate of never being married, a low level of education, unemployment, a history of narcotics use, and a history of crime. About 60 percent of the subjects had concurrent psychotic disorders with a combination of psychotic disorder and substance use disorder (PSCD group). Compared with non-psychotic substance use disorder patients (NPs-SUD group), those in the PSCD group were younger, unemployment, and tended to have a history of narcotics use and crime. A certain improvement partially effect was seen as a result of this program in PSCD group, with increases in the function of generalization, schedule for assessment of insight, effective for stopping the substance use. But self-rating scales was not seen improvement effect by row value self-efficacy scale.
In addition to these interventions, the concurrent use of individual interventions to raise self-efficacy , other programs for psychopathic symptoms and/or to participate repetition is thought to be necessary for patients with concurrent psychotic disorders. In the future, more active implementation of simple programs for this type of concurrent disorder will be required at a greater number of designated hospitals for forced psychiatric treatment.

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

Main results already published

Date of protocol fixation

2013 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 25 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete

2016 Year 01 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 19 Day

Last modified on

2017 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name