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
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
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
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
