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Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling

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ClinicalTrials.gov Identifier: NCT01529047
Recruitment Status : Unknown
Verified December 2013 by Mary Larimer, University of Washington.
Recruitment status was:  Enrolling by invitation
First Posted : February 8, 2012
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mary Larimer, University of Washington

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
gambling behavior and consequences [ Time Frame: across 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling
Official Title  ICMJE RTC of Web Versus In-Person SUD and Comorbidity Treatment
Brief Summary Rates of gambling and substance use behaviors are elevated among emerging adults (ages 18-24), and these behaviors are individually and jointly associated with a host of negative consequences. Evidence suggests there is significant overlap between these behaviors as well as comorbidity of associated mental disorders (i.e., pathological gambling and substance abuse/dependence). Prior research suggests that a brief in-person delivered personalized feedback intervention (PFI) may be an effective method of reducing these behaviors and their associated consequences among emerging adults. Thus, the purpose of this study is to determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample of emerging adults, as well as explore potential moderators and mediators of intervention efficacy and the longevity of intervention effects (over a period of 18-months).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Gambling
  • Alcohol Consumption
  • Cannabis
Intervention  ICMJE Behavioral: Personalized Feedback Intervention
Printed or electronic form containing personalized information about health-relevant behaviors
Study Arms  ICMJE
  • Experimental: In-person PFI
    In-person personalized feedback intervention
    Intervention: Behavioral: Personalized Feedback Intervention
  • Experimental: Web-based PFI
    Web-based personalized feedback intervention
    Intervention: Behavioral: Personalized Feedback Intervention
  • No Intervention: Assessment Only
    Complete online survey assessments only.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Endorse disordered gambling behavior (including 1 or more consequence)
  • Meet diagnostic criteria for one or more substance use disorder

Exclusion Criteria:

  • Not meeting inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529047
Other Study ID Numbers  ICMJE 35898-C
R01DA025051 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Larimer, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Mary E Larimer, Ph.D. University of Washington Dept of Psychiatry & Behavioral Sciences
PRS Account University of Washington
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP