Substance Abuse DisorderNCT01142609
Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
A study testing eGet in people with Substance Abuse Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse Disorder
- What is being tested?
- eGet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No access to a computer with Internet capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Treatment Services
Baltimore, Maryland, 21224
About this study
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).
Read the 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.
- Conditions
- Substance Abuse Disorder
- Being tested
- eGet
- Keywords
- Web based videoconferencing, methadone, substance abuse counseling
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGetBehavioural
eGet individual counseling sessions from home will be scheduled weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet (eGetgoing) | Experimental | Subjects will assigned to use an accredited web-based platform (eGetgoingTM, CRC Health Group, Inc.) to deliver routine substance abuse counseling. Receives: Behavioral: eGet |
| Routine on-site | No intervention | Subjects will attend routine face-to-face individual counseling sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counseling efficacy
Attendance to individual counseling sessions, both online and on-site will be tracked weekly for the duration of the study.
Measured: Weekly for 12 weeks
Reinforcement value (eGetgoing)
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).
Measured: Monthly for 3 months
Reinforcement value (on-site)
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).
Measured: Baseline
Secondary outcomes (3)
Program Satisfaction
Subjects will complete a survey to assess their overall program satisfaction
Measured: Baseline and monthly for 3 months
Treatment cost
Subjects will complete surveys to measure treatment related time and monetary travel costs.
Measured: Baseline and Month 3
Therapeutic relationship
Subjects and their therapists will complete surveys to assess qualities of the therapeutic relationship.
Measured: Baseline and monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Van King, Johns Hopkins University
- Investigators
- Van King, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142609
- Sponsor's protocol ID
- 1RC1DA028189-01
- Other IDs
- 1RC1DA028189-01
- Status last verified
- Apr 2013
- First submitted
- 10 Jun 2010
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
- ClinicalTrials.gov ID
- NCT01142609
- Acronym / sponsor ID
- 1RC1DA028189-01
- Conditions
- Substance Abuse Disorder
- Keywords
- Web based videoconferencing, methadone, substance abuse counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet (eGetgoing) | Experimental | Behavioral: eGetSubjects will assigned to use an accredited web-based platform (eGetgoingTM, CRC Health Group, Inc.) to deliver routine substance abuse counseling. |
| Routine on-site | No intervention | –Subjects will attend routine face-to-face individual counseling sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No access to a computer with Internet capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eGeteGet individual counseling sessions from home will be scheduled weekly for 12 weeks. | Behavioural | Internet (eGetgoing) |
Primary outcome
Counseling efficacy
Time frame: Weekly for 12 weeks
Attendance to individual counseling sessions, both online and on-site will be tracked weekly for the duration of the study.
Reinforcement value (eGetgoing)
Time frame: Monthly for 3 months
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).
Reinforcement value (on-site)
Time frame: Baseline
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).
3 secondary outcomes
Program Satisfaction
Time frame: Baseline and monthly for 3 months
Treatment cost
Time frame: Baseline and Month 3
Therapeutic relationship
Time frame: Baseline and monthly for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van King, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eGet in people with Substance Abuse Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counseling efficacy (time frame: Weekly for 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.