title: Web-based cognitive behavioral relapse prevention program with tailored feedback for people with methamphetamine and other drug use problems: protocol for a multicenter randomized controlled trial in Japan.
abstract: BACKGROUND
  Despite the effectiveness of psychosocial programs for recovery from drug use problems, there have been challenges in implementation of treatment. Internet-based and computerized approaches have been known to be effective in treatment dissemination. The study purpose is to assess the effects of a web-based psychosocial relapse prevention program with a multicenter randomized controlled trial.
  
  
  METHODS
  Recruitment began in January 2015 for outpatient participants diagnosed with drug abuse or dependence who have used a primary abused drug in the past year at psychiatric hospitals and a clinic. Participants are randomized either to a web-based relapse prevention program or a self-monitoring group. The intervention is a web-based relapse prevention program named "e-SMARPP" that consists of six relapse prevention program modules with tailored feedback from health care professionals and 8 weeks of self-monitoring. The content is adapted from a face-to-face relapse prevention program which is based on cognitive behavioral therapy and motivational enhancement. The primary outcomes are relapse risk assessed by the Stimulant Relapse Risk Scale (baseline, 2-, 5- and 8-month) and the longest duration of consecutive abstinent days from primary abused drug during the intervention. Secondary outcomes will include motivation to change, self-efficacy for drug use and craving, abstinent days in the past 28 or 56 days, quality of life, sense of coherence, cost of substance use, medical cost, retention of treatment and use of self-help group. Completion, usability and satisfaction of the program will be also assessed to explore feasibility. This study protocol was approved by the Ethics Committee of The University of Tokyo and each recruiting hospital and clinic.
  
  
  CONCLUSIONS
  To our knowledge, this study is the first clinical trial to assess the effects of a web-based therapeutic program for drug users in Japan. If successful, this program is a promising approach for drug user treatment in Japan, where the stigma toward drug users is strong. The results are also useful for researchers who want to know about programs for various substances, including methamphetamine.
  
  
  BACKGROUND
  This trial was registered with the University Hospital Medical Information Network clinical trial registry: UMIN000016075 (Date of registration: January 5, 2015).
authors.affiliation: Department of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. ayumi-takano@umin.ac.jp.
authors.forename: Ayumi
authors.initials: A
authors.lastname: Takano
authors.affiliation: Department of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Miyamoto
authors.affiliation: Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Norito
authors.initials: N
authors.lastname: Kawakami
authors.affiliation: Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8553, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Matsumoto
authors.affiliation: Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Shinozaki
authors.affiliation: Department of Health Technology Assessment and Public Policy, Graduate School of Public Policy, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sugimoto
mesh_terms: D015928:Cognitive Behavioral Therapy / Q000379:methods*; D030141:Feedback, Psychological; D005260:Female; D006801:Humans; D020407:Internet; D007564:Japan; D008297:Male; D008694:Methamphetamine / Q000009:adverse effects; D009042:Motivation; D015397:Program Evaluation / Q000706:statistics & numerical data*; D012008:Recurrence; D019966:Substance-Related Disorders / Q000523:psychology / Q000628:therapy*
chemical_list: D008694:Methamphetamine
keywords: Cognitive behavioral therapy; Drug dependence; Internet; Methamphetamine; Motivational interviewing; Relapse prevention; Self-monitoring; Web-based