- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01142609
Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
April 2, 2013 updated by: Van King, Johns Hopkins University
This research is being done to compare the effectiveness of standard on-site, in-person counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients in opioid-agonist treatment programs.
The study is looking to see if there are any differences in satisfaction or in treatment outcome if counseling sessions are given by e-therapy compared to standard, in-person counseling given in the clinic.
The e-therapy happens in real time- it works very much like standard therapy in the clinic except that the patient is in his or her own home (or other convenient location outside the clinic) and talks to and sees the therapist through an Internet connection on the computer (the therapist will usually be at the clinic).
Study Overview
Detailed Description
This study will be the first to evaluate the efficacy of an accredited and currently available, Internet web-based videoconferencing platform to deliver routine schedules of counseling in an opioid agonist treatment program.
It has outstanding potential to help determine transportability of this technology to other treatment programs by demonstrating the benefits of integration of web-based therapy with on-site services to expand the continuum of care.
Study Type
Interventional
Enrollment (Actual)
85
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 Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Addiction Treatment Services
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Access to a computer with Internet capability
- Full adherence to their routine counseling schedule over the previous 30-days
- Negative urine specimens over the previous 30-days
- Patient at ATS for 90 days
Exclusion Criteria:
- No access to a computer with Internet capability
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet (eGetgoing)
Subjects will assigned to use an accredited web-based platform (eGetgoingTM, CRC Health Group, Inc.) to deliver routine substance abuse counseling.
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eGet individual counseling sessions from home will be scheduled weekly for 12 weeks.
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No Intervention: Routine on-site
Subjects will attend routine face-to-face individual counseling sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Counseling efficacy
Time Frame: Weekly for 12 weeks
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Attendance to individual counseling sessions, both online and on-site will be tracked weekly for the duration of the study.
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Weekly for 12 weeks
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Reinforcement value (eGetgoing)
Time Frame: Monthly for 3 months
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Subjects will complete monthly surveys to evaluate the reinforcement value of eGetgoing using a multiple choice design that will compare its perceived value to other aspects of routine treatment (e.g., take-home medications).
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Monthly for 3 months
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Reinforcement value (on-site)
Time Frame: Baseline
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Subjects will complete a survey to evaluate the reinforcement value of eGetgoing using a multiple choice design that will compare its perceived value to other aspects of routine treatment (e.g., take-home medications).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Satisfaction
Time Frame: Baseline and monthly for 3 months
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Subjects will complete a survey to assess their overall program satisfaction
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Baseline and monthly for 3 months
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Treatment cost
Time Frame: Baseline and Month 3
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Subjects will complete surveys to measure treatment related time and monetary travel costs.
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Baseline and Month 3
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Therapeutic relationship
Time Frame: Baseline and monthly for 3 months
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Subjects and their therapists will complete surveys to assess qualities of the therapeutic relationship.
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Baseline and monthly for 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Van King, M.D., Johns Hopkins University
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
December 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
June 10, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 2, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1RC1DA028189-01 (U.S. NIH Grant/Contract)
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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