Substance Use DisorderSBIRTNCT01003834
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
A study testing Computerized brief intervention, Computerized health screening and Computerized assessment in people with Substance Use Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Computerized brief intervention, Computerized health screening and Computerized assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 713 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years
- Primary care clinic patient
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care
This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.
The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.
- Conditions
- Substance Use Disorder
- Being tested
- Computerized brief intervention, Computerized health screening, Computerized assessment, Therapist-delivered motivational intervention
- Keywords
- substance use, drug use, drug abuse
- 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.
Computerized brief interventionBehavioural
Intervention based on Motivational Interviewing technique
Computerized health screeningBehavioural
Behavioral intervention
Computerized assessmentBehavioural
Behavioral intervention
Therapist-delivered motivational interventionBehavioural
Behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Screening only Receives: Behavioral: Computerized health screening |
| Assessment | Active comparator | Screening plus assessment Receives: Behavioral: Computerized health screening; Behavioral: Computerized assessment |
| Computer Intervention | Experimental | Screening, assessment, and computer-delivered intervention Receives: Behavioral: Computerized brief intervention; Behavioral: Computerized health screening; Behavioral: Computerized assessment |
| Therapist Intervention | Active comparator | Screening, Assessment, and therapist-delivered intervention Receives: Behavioral: Computerized health screening; Behavioral: Computerized assessment; Behavioral: Therapist-delivered motivational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dace Svikis, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003834
- Sponsor's protocol ID
- SBIRTVCU
- Other IDs
- R01DA026091
- Acronym
- SBIRT
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 2009
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care
- ClinicalTrials.gov ID
- NCT01003834
- Acronym / sponsor ID
- SBIRT / SBIRTVCU
- Conditions
- Substance Use Disorder
- Keywords
- substance use, drug use, drug abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Oct 2009 (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 is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.
The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Computerized health screeningScreening only |
| Assessment | Active comparator | Behavioral: Computerized health screening, Behavioral: Computerized assessmentScreening plus assessment |
| Computer Intervention | Experimental | Behavioral: Computerized brief intervention, Behavioral: Computerized health screening, Behavioral: Computerized assessmentScreening, assessment, and computer-delivered intervention |
| Therapist Intervention | Active comparator | Behavioral: Computerized health screening, Behavioral: Computerized assessment, Behavioral: Therapist-delivered motivational interventionScreening, Assessment, and therapist-delivered intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 65 years
- Primary care clinic patient
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Computerized brief interventionIntervention based on Motivational Interviewing technique | Behavioural | Computer Intervention |
| Computerized health screeningBehavioral intervention | Behavioural | Assessment, Computer Intervention, Control, Therapist Intervention |
| Computerized assessmentBehavioral intervention | Behavioural | Assessment, Computer Intervention, Therapist Intervention |
| Therapist-delivered motivational interventionBehavioral intervention | Behavioural | Therapist Intervention |
Primary outcome
Substance use
Time frame: 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 8 Dec 2015.
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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.
Dace Svikis, PhD principal investigator
Virginia Commonwealth 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 Computerized brief intervention, Computerized health screening and Computerized assessment in people with Substance Use Disorder, run by Virginia Commonwealth 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 2 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 8 Dec 2015. 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. Some participants in this study may receive a placebo. 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?
Substance use (time frame: 3 months). 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 8 Dec 2015.