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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01142609
Other study ID # 1RC1DA028189-01
Secondary ID 1RC1DA028189-01
Status Completed
Phase N/A
First received June 10, 2010
Last updated April 2, 2013
Start date December 2009
Est. completion date August 2012

Study information

Verified date April 2013
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
eGet
eGet individual counseling sessions from home will be scheduled weekly for 12 weeks.

Locations

Country Name City State
United States Addiction Treatment Services Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Counseling efficacy Attendance to individual counseling sessions, both online and on-site will be tracked weekly for the duration of the study. Weekly for 12 weeks No
Primary 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). Monthly for 3 months No
Primary 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). Baseline No
Secondary Program Satisfaction Subjects will complete a survey to assess their overall program satisfaction Baseline and monthly for 3 months No
Secondary Treatment cost Subjects will complete surveys to measure treatment related time and monetary travel costs. Baseline and Month 3 No
Secondary Therapeutic relationship Subjects and their therapists will complete surveys to assess qualities of the therapeutic relationship. Baseline and monthly for 3 months No
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