UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study of cognitive behavioral therapy program for patients with substance use disorder and other mental disorders
Title of the study (Brief title)	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	Junko Inamoto
Organization	Showa University
Division name	School of Medicine, Department of Psychiatry
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	Tomohiro Ikeda
Organization	Showa University
Division name	School of Medicine, Department of Psychiatry
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
Institute	Department of Psychiatry Showa University, School of Medicine
Institute
Department

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

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014436