UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016075 |
|---|---|
| Receipt number | R000018484 |
| Scientific Title | Development and evaluation of the effectiveness of an Internet-based cognitive behavioral relapse prevention program for people with drug use problems: a multicenter study |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2020/01/01 12:01:00 |
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Basic information
Public title
Development and evaluation of the effectiveness of an Internet-based cognitive behavioral relapse prevention program for people with drug use problems: a multicenter study
Acronym
Effectiveness of a web-based cognitive behavioral relapse prevention program for people with drug use problems: a multicenter randomized controlled trial
Scientific Title
Development and evaluation of the effectiveness of an Internet-based cognitive behavioral relapse prevention program for people with drug use problems: a multicenter study
Scientific Title:Acronym
Effectiveness of a web-based cognitive behavioral relapse prevention program for people with drug use problems: a multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
Substance use disorder/ Substance abuse or dependence (psychoactive substances other than alcohol and tobacco)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effectiveness of a web-based cognitive behavioral relapse prevention program in assisting individuals who wish to address drug use problems. We hypothesized that at the 8th, 20th and 32nd week of the follow-up assessment, the intervention group will report lower relapse risk and a longer period of abstinent days, compared to a control group that only received web-based self-monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Relapse risk (assessed by the Stimulant Relapse Risk Scale) assessment at the 8th (immediately after intervention), 20th and 32nd week after start of intervention
2) The longest period of abstinent days from primary abused drug during the 56-day intervention period (assessed by self-reports using the self-monitoring calendar)
Key secondary outcomes
1)-10) at assessments in the 8th (immediately after intervention), 20th and 32nd week after start of intervention
1) Motivation toward treatment and behavioral change (assessed by the Stage of Change Readiness and Treatment Eagerness Scale 8D)
2) Confidence in dealing with drug use cravings (assessed by Self-efficacy Scale for Drug Dependence)
3) Percentage of days abstinent from primary abused drug in the past 28 or 56 days (assessed by self-reports using the self-monitoring calendar or the Timeline Follow-back method)
4) Changes in the period of abstinent days from primary abused drug in the past 28 days (assessed by self-reports using the self-monitoring calendar or the Timeline Follow-Back method)
5) Expenses for drugs or alcohol in the last month
6) Retention in outpatient treatment (yes or no)
7) Involvement in self-help groups (yes or no)
8) Use of rehabilitation facilities (yes or no)
9) Health related QOL (assessed by WHOQOL26)
10) Sense of coherence (assessed by 3-item sense of coherence scale)
11) At baseline and 32-week follow-up assessment, psychiatric medical cost in the past 6 months (self-reported period and frequency of hospitalization, outpatient visit, prescription and group therapy).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A weekly 6-session web-based cognitive behavioral relapse prevention program (about 60 minutes per session), web-based day-by-day self-monitoring, provision of relevant information, and usual outpatient treatment for 8 weeks.
Interventions/Control_2
Web-based day-by-day self-monitoring, provision of relevant information, and usual outpatient treatment for 8 weeks.
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) Outpatients who were diagnosed with substance use disorder (abuse or dependence) assessed by DSM-IV or V (psychoactive substances other than alcohol and tobacco)
2) Those who used a primary abused drug in the past year
3) Those with access to the Internet via PC, smartphone or tablet computer and can exchange e-mail.
Key exclusion criteria
1) Patients with severe physical diseases
2) Patients with high suicide risk
3) Patients with severe symptoms of substance-induced psychotic disorder
4) Patients with impaired cognitive function
5) Those judged ineligible to participate in the study by a psychiatrist.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norito |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyuo-ku, Tokyo
TEL
0358413522
ayumi-takano@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Takano |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3522
Homepage URL
ayumi-takano@umin.ac.jp
Sponsor or person
Institute
Department of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Faculty of Medicine and Graduate School of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
国立精神・神経医療研究センター病院（東京都）、埼玉県立精神医療センター（埼玉県）、神奈川県立精神医療センター（神奈川県）、岡山県精神科医療センター（岡山県）、東京都立松沢病院（東京都）、アパリクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 05 | 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
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
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018484
