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Contingency Management as an Adjunct Treatment for Rural and Remote Disordered Gamblers

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ClinicalTrials.gov Identifier: NCT02953899
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Alberta Rural Development Network
Information provided by (Responsible Party):
Darren R. Christensen, University of Lethbridge

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 3, 2016
Last Update Posted Date May 22, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
Gambling Abstinence [ Time Frame: 12 weeks ]
The total number of sessions that a participant provided evidence of gambling abstinence in the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02953899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Session Attendance [ Time Frame: 12-weeks ]
    The total number of sessions that a participant attended the study
  • Study Retention [ Time Frame: 12-weeks ]
    The total number of weeks that a participant attended the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contingency Management as an Adjunct Treatment for Rural and Remote Disordered Gamblers
Official Title  ICMJE Piloting the Addition of Contingency Management to Best Practice Counselling as an Adjunct Treatment for Rural and Remote Disordered Gamblers
Brief Summary The purpose of this project is to pilot contingency management as an adjunct treatment to counselling as usual using internet delivered video-conferencing applications for remote disordered gamblers. This project further investigates the impact of adding contingency management to counselling to improve counselling attendance and retention and uses internet-delivered approaches to assist rural and remote disordered gamblers gain access to counselling treatments.
Detailed Description The chosen methodology is a randomised clinical trial where participants are allocated into one of two conditions; Contingency Management and Cognitive Behavioural Therapy (CM+), or Cognitive Behavioural Therapy alone (CBT) for the treatment of disordered gambling. Participants will experience a battery of tests pre- and post-treatment examining clinical, psychological, and behavioural issues, including co-morbid substance use. Alberta Rural Development Network (ARDN) affiliates will be provided with information regarding how participants can access the Qualtrics study site (e.g., an on-line survey hosting company) and will be individually directed to the study site by the principal investigator to complete the consent form and the base-line assessments. Counselling will be provided free of charge using Skype or Facetime video-conferencing internet applications. Participation in each condition will last 14 weeks: 12 weeks for treatment, and 2 weeks of assessments (one week prior to treatment and one week post treatment). Pre-treatment assessments (including demographic information) will take approximately 30-45 minutes, as will the post-treatment assessments. The progress check-ups by the Principal Investigator will take 5 to 10 minutes. A subset of treatment seekers, counsellors, and community/project stakeholders (e.g., ARDN affiliates) will also be chosen to participate in qualitative interviews to explore their experiences as well as their perceptions regarding the utility of the program for residents of rural and remote areas. The qualitative interviews will take approximately 30-60 minutes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gambling Disorder
Intervention  ICMJE
  • Behavioral: Contingency Management
    In addition to Cognitive Behavioural Therapy, this intervention uses small incentives to reinforce study attendance and gambling abstinence.
  • Behavioral: Cognitive Behavioural Therapy
    This intervention uses psychoeducation, behavioural strategies, and cognitive restructuring to assist the participant in their efforts to become abstinent from gambling.
Study Arms  ICMJE
  • Experimental: Contingency Management
    This is a treatment where participants earn points for treatment attendance and for providing evidence of gambling abstinence. These points are added to study accounts that can be redeemed for goods and services available at a variety of on-line businesses (e.g., Amazon, Walmart, etc.). Submission of evidence of gambling behaviour or non-attendance at an on-line counselling session re-sets subsequent points to the starting level. The CM procedure is implemented as part of the CBT counselling session.
    Intervention: Behavioral: Contingency Management
  • Active Comparator: Cognitive Behavioural Therapy
    CBT is currently considered "best practice" for the treatment of problem gambling, as noted in the National Health and Medical Research Council (Australia) endorsed Clinical Guidelines for problem and pathological gambling treatment (Problem Gambling Research and Treatment Centre, 2011). CBT is typically a semi-structured approach for delivering cognitive behavioural therapy addressing the participant's experiences, thoughts, and emotions relating to their gambling and substance use. Techniques include psychoeducation, behavioural interventions, and cognitive strategies. Participants are expected to attend on-line counselling sessions three times a week for approximately 12 weeks. All participants will receive individual counselling from an experienced counsellor/therapist.
    Intervention: Behavioral: Cognitive Behavioural Therapy
Publications * Christensen DR, Witcher CSG, Leighton T, Hudson-Breen R, Ofori-Dei S. Piloting the addition of contingency management to best practice counselling as an adjunct treatment for rural and remote disordered gamblers: study protocol. BMJ Open. 2018 Apr 3;8(4):e018804. doi: 10.1136/bmjopen-2017-018804.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
55
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • capable of providing written consent,
  • received a diagnosis of gambling disorder (American Psychiatric Association, 2013),
  • gambled within the last month,
  • live in a rural or remote location, and
  • speak English

Exclusion Criteria:

  • Medically unmanaged psychiatric or neurological disorder(s) except for disordered gambling
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Darren R Christensen, PhD 403-329-5124 darren.christensen@uleth.ca
Contact: Chad Witcher, PhD 403-332-4439 chad.witcher@uleth.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953899
Other Study ID Numbers  ICMJE 2016-080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only the research team will have access to the individual participant data
Responsible Party Darren R. Christensen, University of Lethbridge
Study Sponsor  ICMJE University of Lethbridge
Collaborators  ICMJE Alberta Rural Development Network
Investigators  ICMJE
Principal Investigator: Darren R Christensen, PhD University of Lethbridge
PRS Account University of Lethbridge
Verification Date May 2019

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