UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051449 |
|---|---|
| Receipt number | R000058684 |
| Scientific Title | A study on development and evaluation of individual cognitive behavioral therapy for substance dependence and addictive behaviors |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2023/06/26 11:57:13 |
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Basic information
Public title
A study on development and evaluation of individual cognitive behavioral
therapy for substance dependence and addictive behaviors
Acronym
A study on development and evaluation of individual cognitive behavioral
therapy for substance dependence and addictive behaviors
Scientific Title
A study on development and evaluation of individual cognitive behavioral
therapy for substance dependence and addictive behaviors
Scientific Title:Acronym
A study on development and evaluation of individual cognitive behavioral
therapy for substance dependence and addictive behaviors
Region
| Japan |
Condition
Condition
Substance Use Disorder Gambling Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the efficacy of an individual cognitive behavioral therapy program for substance dependence and addictive behaviors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days of use (implementation) in the last 30 days.
Key secondary outcomes
TMD score (POMS2 shortened version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The developed individual cognitive behavioral therapy for about four months.
Interventions/Control_2
The existing group cognitive behavioral therapy for about four months.
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) Those who continue treatment for alcohol use, drug use, or gambling disorder at a research institution.
2) Those who meet the criteria for the diagnosis of substance use disorder and gambling disorder according to the DSM-5.
3) Those who do not have comorbidities or mental or physical problems that should be treated in preference to the disorders described in 2) .
4) Those who do not need to be hospitalized and are able to receive outpatient treatment.
5) Those who have received an explanation about this research and voluntarily agreed to it.
6) A person who is 20 years of age or older at the time of obtaining consent.
Key exclusion criteria
Patients whose primary physician determines that treatment with individual or collective CBT is inappropriate.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Matsumoto |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health Department of Drug Dependence Research
Zip code
187-8553
Address
4-1- 1 Ogawahigashicho, Kodaira, Tokyo,
TEL
042-346-1954
tmatsu@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kondo |
Organization
National Institute of Mental Health Department of Drug Dependence Research
Division name
National Institute of Mental Health Department of Drug Dependence Research
Zip code
187-8553
Address
4-1- 1 Ogawahigashicho, Kodaira
TEL
042-346-1954
Homepage URL
a-kondo@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Toshihiko Matsumoto
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1- 1 Ogawahigashicho, Kodaira, Tokyo
Tel
042-341-2712
rinri-jimu@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
| 2023 | Year | 06 | Month | 26 | 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
69
Results
A repeated measures ANOVA revealed that the difference in the number of days of use (implementation) in the past 30 days at the three timepoints was not significant (F value = 0.075, p = 0.838), that there was no interaction (F value = 0.095, p = 0.814), and that there was no significant difference observed in the number of days of use (implementation) in the past 30 days between both groups (F value = 0.017, p = 0.898).
Results date posted
| 2023 | Year | 06 | Month | 26 | Day |
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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058684
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| Registered date | File name |
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