- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953899
Contingency Management as an Adjunct Treatment for Rural and Remote Disordered Gamblers
December 4, 2023 updated by: Darren R. Christensen, University of Lethbridge
Piloting the Addition of Contingency Management to Best Practice Counselling as an Adjunct Treatment for Rural and Remote Disordered Gamblers
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darren R Christensen, PhD
- Phone Number: 403-329-5124
- Email: darren.christensen@uleth.ca
Study Contact Backup
- Name: Chad Witcher, PhD
- Phone Number: 403-332-4439
- Email: chad.witcher@uleth.ca
Study Locations
-
-
Alberta
-
Lethbridge, Alberta, Canada, T1K 3M4
- Recruiting
- University of Lethbridge
-
Contact:
- Chad Witcher, PhD
- Phone Number: 403-332-4439
- Email: chad.witcher@uleth.ca
-
Contact:
- Darren R Christensen, PhD
- Phone Number: 4033295124
- Email: darren.christensen@uleth.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
In addition to Cognitive Behavioural Therapy, this intervention uses small incentives to reinforce study attendance and gambling abstinence.
|
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.
|
This intervention uses psychoeducation, behavioural strategies, and cognitive restructuring to assist the participant in their efforts to become abstinent from gambling.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gambling Abstinence
Time Frame: 12 weeks
|
The total number of sessions that a participant provided evidence of gambling abstinence in the study
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Session Attendance
Time Frame: 12-weeks
|
The total number of sessions that a participant attended the study
|
12-weeks
|
Study Retention
Time Frame: 12-weeks
|
The total number of weeks that a participant attended the study
|
12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darren R Christensen, PhD, University of Lethbridge
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 1, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimated)
November 3, 2016
Study Record Updates
Last Update Posted (Actual)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only the research team will have access to the individual participant data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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