Substance AbuseNCT01501318
Impact of Personalized Feedback Alone on Substance Use Behaviors
A study testing Personalized feedback report and Personalized feedback report plus education in people with Substance Abuse, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Personalized feedback report and Personalized feedback report plus education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 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 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low level risky substance use
Who cannot join
- high substance use risk levels
- potential alcohol or drug addiction or dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital ER
Columbia, Missouri, 65212
About this study
Official title: Brief Education to Reduce Health Care Consumers' Risky Substance Use Behaviors: How Brief is Brief?
The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.
Read the detailed description
Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.
Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.
Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..
- Conditions
- Substance Abuse
- Being tested
- Personalized feedback report, Personalized feedback report plus education
- Keywords
- SBIRT, brief intervention, alcohol, 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.
Personalized feedback reportBehavioural
Participants receive the personalized feedback report but no additional education.
Personalized feedback report plus educationBehavioural
Participants receive the personalized feedback report plus education. This is the currently implemented service approach.
| Study group | Role | What they receive |
|---|---|---|
| Personalized feedback plus education | Active comparator | Participants receive the personalized feedback report plus education. This is the currently implemented service approach.Treatment as usual with participants receiving a personalized feedback report about the risks associated with their current substance use behaviors and a brief (5-15 minute) motivational interviewing based education session provided by a trained health coach. Receives: Behavioral: Personalized feedback report plus education |
| Personalized feedback report alone | Experimental | Provision of the personalized feedback report alone. Receives: Behavioral: Personalized feedback report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use behaviors and consequences
Interview questionnaire includes items concerning substance use behaviors (e.g., the number of drinks in the last 7 days) and consequences {e.g., ''During the past month, how often have you failed to do what was normally expected of you because of your use of alcohol?'
Measured: 1 month follow-up
Secondary outcomes (1)
Substance use behavioral intentions
Interview questionnaire that asks participants about their memory of the materials provided in the intervention, their motivation toward change, and their self-reported change efforts.
Measured: 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, St. Louis, Institute of Mental Health, Singapore
- Responsible party
- Sponsor
- Investigators
- Matthew G Hile, PhD, Principal investigator, Missouri Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501318
- Sponsor's protocol ID
- 1200450
- Status last verified
- Sep 2016
- First submitted
- 23 Dec 2011
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Education to Reduce Health Care Consumers' Risky Substance Use Behaviors: How Brief is Brief?
- ClinicalTrials.gov ID
- NCT01501318
- Acronym / sponsor ID
- 1200450
- Conditions
- Substance Abuse
- Keywords
- SBIRT, brief intervention, alcohol, drug abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Missouri, St. Louis, Institute of Mental Health, Singapore
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Dec 2011 (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.
The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.
Detailed description
Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.
Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.
Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized feedback plus education | Active comparator | Behavioral: Personalized feedback report plus educationParticipants receive the personalized feedback report plus education. This is the currently implemented service approach.Treatment as usual with participants receiving a personalized feedback report about the risks associated with their current substance use behaviors and a brief (5-15 minute) motivational interviewing based education session provided by a trained health coach. |
| Personalized feedback report alone | Experimental | Behavioral: Personalized feedback reportProvision of the personalized feedback report alone. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low level risky substance use
Key exclusion criteria (2 listed)
- high substance use risk levels
- potential alcohol or drug addiction or dependence
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 |
|---|---|---|
| Personalized feedback reportParticipants receive the personalized feedback report but no additional education. | Behavioural | Personalized feedback report alone |
| Personalized feedback report plus educationParticipants receive the personalized feedback report plus education. This is the currently implemented service approach. | Behavioural | Personalized feedback plus education |
Primary outcome
Substance use behaviors and consequences
Time frame: 1 month follow-up
Interview questionnaire includes items concerning substance use behaviors (e.g., the number of drinks in the last 7 days) and consequences {e.g., ''During the past month, how often have you failed to do what was normally expected of you because of your use of alcohol?'
1 secondary outcome
Substance use behavioral intentions
Time frame: 1 month follow-up
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 30 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Matthew G Hile, PhD principal investigator
Missouri Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized feedback report and Personalized feedback report plus education in people with Substance Abuse, run by University of Missouri-Columbia 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 1 inclusion and 2 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 30 Sep 2016. 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?
Substance use behaviors and consequences (time frame: 1 month follow-up). 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 30 Sep 2016.