UMIN-CTR Clinical Trial

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
Email	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
Email	ayumi-takano@umin.ac.jp

Sponsor
Institute	Department of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018484