Substance Use DisordersSBIRT in MHNCT01883791
Screening, Brief Intervention and Referral to Treatment for Substance Abuse in Mental Health Treatment Settings
A study testing SBIRT and Health Education in people with Substance Use Disorders and Mental Illness, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol and/or drug use. One model of intervention that has been shown effective in medical settings to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief intervention, and referral to treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Mental Illness
- What is being tested?
- SBIRT and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to 30 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)have affective disorder (Major Depressive Disorder, Dysthymia, Bipolar Disorder) or psychotic disorder (Schizophrenia, Schizoaffective, or Psychotic Disorder Not Otherwise Specified),
- (2) have any use of cannabis or stimulants in the past year or a heavy drinking day (5+/4+ drinks for men/women) in the past year,
- (3) are 18 years or older,
- (4) have a stable living situation (i.e., has not been homeless during the past two years),
- (5) are not under the influence of alcohol and/or drugs at the time of enrollment and
- (6) have not received substance abuse treatment within the past year.
Who cannot join
- (1) have received any substance abuse treatment in the past year will be excluded because exposure to addiction treatment may confound the effects of the SBIRT intervention.
- (2) have Opiate and opioid use because we cannot guarantee access to appropriate pharmacotherapies (e.g., suboxone or methadone).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Inpatient and Outpatient Psychiatric Units
Los Angeles, California, 90025
Ventura County Behavioral Health
Oxnard, California, 93036
About this study
An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol and/or drug use. One model of intervention that has been shown effective in medical settings to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in mental health treatment settings. Given the proportionately large number of mental health patients who also engage in hazardous substance use, research is needed to find an appropriate and effective substance use intervention for patients in these settings.
The proposed study uses a randomized controlled trial to examine the extent to which the World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) and its associated brief behavioral intervention, leads to reductions in substances prevalent in mental health settings: alcohol, cannabis and stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose level of substance misuse indicates a need for treatment, initiation and engagement into SUD treatment services. Eligible participants will be mental health patients who report any past year use of cannabis or stimulants or at least one heavy drinking day in the past year. Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly assigned to either the SBIRT intervention condition or to a health education attention control condition. Participants will be assessed at baseline on substance use, psychiatric symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month follow up points for alcohol and drug use, involvement in SUD treatment services, severity of psychiatric symptoms and quality of life. If successful this study will yield valuable new knowledge about the effectiveness of SBIRT in mental health treatment settings and will promote improved well being of mental health patients. Further, the study will provide evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this research will be used as the basis for broader dissemination and of SBIRT in mental health settings.
Read the detailed description
Research Design and Methods The proposed 5-year study is a randomized, controlled trial of screening, brief intervention, and referral to treatment (SBIRT) for alcohol, cannabis and stimulant use in mental health treatment settings. These 3 substances have been chosen as the focus for the proposed study because (a) in the US alcohol and cannabis are the most common substances used by individuals with serious mental illness in the general population1 and (b) stimulant use (in particular, methamphetamine) is a significant public health threat in the US. 31,32 The SBIRT model will be tested in a two-group design in which eligible participants (N=750) will be randomly assigned to either the SBIRT intervention condition (N=375) or to a control condition (N=375) that offers an informational leaflet. The participants will comprise male and female mental health patients who have a positive pre-screen for being at risk of having or developing a substance use disorder. The performance site for the study will be publicly-funded mental health clinics in Ventura County, California. All participants (intervention and control groups) will receive mental health care as usual and their participation in the study will in no way reduce the level of usual care they receive.
The SBIRT condition will include the WHO's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and its accompanying brief intervention that uses motivational interviewing techniques to provide feedback, emphasize personal responsibility, give advice, provide a menu of options, convey empathy, and promote self-efficacy.33,34 All participants in the SBIRT condition will complete the ASSIST as an interview. Based on the results of the ASSIST, participants who score in the moderate-risk range for alcohol, cannabis or a stimulant will immediately receive a 15-minute brief intervention. Participants who score in the high-risk range for one of these substances will receive the brief intervention and a referral to a substance abuse treatment facility for further assessment and rehabilitative care. Referral to treatment will be an active intervention and is described below in 'Description of Study Conditions'. We expect that few patients will score in the low-risk range on the ASSIST because the pre-screen for the study (described below in 'Recruitment of Participants and Randomization') should exclude most of these individuals. In the event that any individuals enroll in the study and score in the low-risk range on the ASSIST, their data will be excluded from analysis and they will not be counted toward the target enrollment for the study.
The baseline assessment will occur prior to randomization. Research assistants will administer the assessments in-person at each clinic. Clinical social workers (English and Spanish speaking) will conduct the SBIRT intervention with patients. Follow-up assessments will occur at 3-, 6- and 12-months post baseline.
Project Timeline Table 1 summarizes the main study activities across the 5 years of the project. The research and clinical facilities are in place, but a start-up period of 6 months will be needed to complete the IRB application and approval process, develop data collection templates, train staff and finalize the study protocols and procedures. As shown below in Table 1, subject recruitment will begin in month 7 and extend for 36 months. The timetable for the project is based on an enrollment of 30 participants per month. This rate of recruitment is feasible based on consultations with the mental health treatment sites and will allow for recruitment of 750 participants into the study. As Table 1 shows, the timeline provides adequate time to collect 12-month follow-up data and conduct data analysis.
Table 1: Project Timeline Months 1-6: Training \& start-up activities Months 7-42: Recruitment, SBIRT intervention, \& follow-up activities. 30 Participants recruited/month (N=1080) Months 43-54: Complete follow-up activities Months 55-60: Data Analysis, Report Writing
- Conditions
- Substance Use Disorders, Mental Illness
- Being tested
- SBIRT, Health Education
- Keywords
- substance abuse prevention and treatment, comorbidity, SBIRT
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
Also called Screening, Brief Intervention and Referral to Treatment.
See above Arm description.
Health EducationBehavioural
See Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT | Experimental | The SBIRT condition will include the WHO's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and its accompanying brief intervention that uses motivational interviewing techniques to provide feedback, emphasize personal responsibility, give advice, provide a menu of options, convey empathy, and promote self-efficacy. Receives: Behavioral: SBIRT |
| Health Education | Other | The control group will receive a Health Education (HE) session, informational brochures and a contact information for addiction treatment sites that we will develop with Ventura County. The session will be administered in an individual format for 30-minutes and will address general health, wellness and lifestyle topics. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back (TLFB)
The TLFB will be used to determine days of use for alcohol and drugs over the 90-day period prior to the baseline assessment. The interviewer will guide the participant to identify the number of standard drinks consumed each day, starting from the day immediately before the assessment and moving backwards in time. Days on which cannabis and/or stimulants were used will also be queried. Variables calculated from the interview will include: (1) total standard drinks, (2) drinking frequency, (3) heavy-drinking frequency (5+ for men; 4+ for women), (4) maximum quantity of alcohol consumed, (5) number of days using cannabis, (6) number of days using cocaine, (7) number of days using methamphetamine, and (8) days on which any alcohol, cannabis or stimulant was used. This measure is completed at 3, 6 and 12 months post baseline in order to measure change from one timepoint to the next.
Measured: These data will be assessed for each 90-day period preceding the 3-, 6- and 12-month follow ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Mitch Karno, Ph.D., Principal investigator, University of California, Los AngelesSuzette Glasner-Edwards, Ph.D., Principal investigator, University of California, Los AngelesRichard Rawson, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883791
- Sponsor's protocol ID
- 1R01DA032733-01A1
- Other IDs
- R01DA032733
- Acronym
- SBIRT in MH
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2012
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Brief Intervention and Referral to Treatment for Substance Abuse in Mental Health Treatment Settings
- ClinicalTrials.gov ID
- NCT01883791
- Acronym / sponsor ID
- SBIRT in MH / 1R01DA032733-01A1
- Conditions
- Substance Use Disorders, Mental Illness
- Keywords
- substance abuse prevention and treatment, comorbidity, SBIRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2013
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Jun 2013 (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.
An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol and/or drug use. One model of intervention that has been shown effective in medical settings to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in mental health treatment settings. Given the proportionately large number of mental health patients who also engage in hazardous substance use, research is needed to find an appropriate and effective substance use intervention for patients in these settings.
The proposed study uses a randomized controlled trial to examine the extent to which the World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) and its associated brief behavioral intervention, leads to reductions in substances prevalent in mental health settings: alcohol, cannabis and stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose level of substance misuse indicates a need for treatment, initiation and engagement into SUD treatment services. Eligible participants will be mental health patients who report any past year use of cannabis or stimulants or at least one heavy drinking day in the past year. Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly assigned to either the SBIRT intervention condition or to a health education attention control condition. Participants will be assessed at baseline on substance use, psychiatric symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month follow up points for alcohol and drug use, involvement in SUD treatment services, severity of psychiatric symptoms and quality of life. If successful this study will yield valuable new knowledge about the effectiveness of SBIRT in mental health treatment settings and will promote improved well being of mental health patients. Further, the study will provide evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this research will be used as the basis for broader dissemination and of SBIRT in mental health settings.
Detailed description
Research Design and Methods The proposed 5-year study is a randomized, controlled trial of screening, brief intervention, and referral to treatment (SBIRT) for alcohol, cannabis and stimulant use in mental health treatment settings. These 3 substances have been chosen as the focus for the proposed study because (a) in the US alcohol and cannabis are the most common substances used by individuals with serious mental illness in the general population1 and (b) stimulant use (in particular, methamphetamine) is a significant public health threat in the US. 31,32 The SBIRT model will be tested in a two-group design in which eligible participants (N=750) will be randomly assigned to either the SBIRT intervention condition (N=375) or to a control condition (N=375) that offers an informational leaflet. The participants will comprise male and female mental health patients who have a positive pre-screen for being at risk of having or developing a substance use disorder. The performance site for the study will be publicly-funded mental health clinics in Ventura County, California. All participants (intervention and control groups) will receive mental health care as usual and their participation in the study will in no way reduce the level of usual care they receive.
The SBIRT condition will include the WHO's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and its accompanying brief intervention that uses motivational interviewing techniques to provide feedback, emphasize personal responsibility, give advice, provide a menu of options, convey empathy, and promote self-efficacy.33,34 All participants in the SBIRT condition will complete the ASSIST as an interview. Based on the results of the ASSIST, participants who score in the moderate-risk range for alcohol, cannabis or a stimulant will immediately receive a 15-minute brief intervention. Participants who score in the high-risk range for one of these substances will receive the brief intervention and a referral to a substance abuse treatment facility for further assessment and rehabilitative care. Referral to treatment will be an active intervention and is described below in 'Description of Study Conditions'. We expect that few patients will score in the low-risk range on the ASSIST because the pre-screen for the study (described below in 'Recruitment of Participants and Randomization') should exclude most of these individuals. In the event that any individuals enroll in the study and score in the low-risk range on the ASSIST, their data will be excluded from analysis and they will not be counted toward the target enrollment for the study.
The baseline assessment will occur prior to randomization. Research assistants will administer the assessments in-person at each clinic. Clinical social workers (English and Spanish speaking) will conduct the SBIRT intervention with patients. Follow-up assessments will occur at 3-, 6- and 12-months post baseline.
Project Timeline Table 1 summarizes the main study activities across the 5 years of the project. The research and clinical facilities are in place, but a start-up period of 6 months will be needed to complete the IRB application and approval process, develop data collection templates, train staff and finalize the study protocols and procedures. As shown below in Table 1, subject recruitment will begin in month 7 and extend for 36 months. The timetable for the project is based on an enrollment of 30 participants per month. This rate of recruitment is feasible based on consultations with the mental health treatment sites and will allow for recruitment of 750 participants into the study. As Table 1 shows, the timeline provides adequate time to collect 12-month follow-up data and conduct data analysis.
Table 1: Project Timeline Months 1-6: Training \& start-up activities Months 7-42: Recruitment, SBIRT intervention, \& follow-up activities. 30 Participants recruited/month (N=1080) Months 43-54: Complete follow-up activities Months 55-60: Data Analysis, Report Writing
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT | Experimental | Behavioral: SBIRTThe SBIRT condition will include the WHO's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and its accompanying brief intervention that uses motivational interviewing techniques to provide feedback, emphasize personal responsibility, give advice, provide a menu of options, convey empathy, and promote self-efficacy. |
| Health Education | Other | Behavioral: Health EducationThe control group will receive a Health Education (HE) session, informational brochures and a contact information for addiction treatment sites that we will develop with Ventura County. The session will be administered in an individual format for 30-minutes and will address general health, wellness and lifestyle topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1)have affective disorder (Major Depressive Disorder, Dysthymia, Bipolar Disorder) or psychotic disorder (Schizophrenia, Schizoaffective, or Psychotic Disorder Not Otherwise Specified),
- (2) have any use of cannabis or stimulants in the past year or a heavy drinking day (5+/4+ drinks for men/women) in the past year,
- (3) are 18 years or older,
- (4) have a stable living situation (i.e., has not been homeless during the past two years),
- (5) are not under the influence of alcohol and/or drugs at the time of enrollment and
Key exclusion criteria (2 listed)
- (1) have received any substance abuse treatment in the past year will be excluded because exposure to addiction treatment may confound the effects of the SBIRT intervention.
- (2) have Opiate and opioid use because we cannot guarantee access to appropriate pharmacotherapies (e.g., suboxone or methadone).
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 |
|---|---|---|
| SBIRTAlso: Screening, Brief Intervention and Referral to Treatment.See above Arm description. | Behavioural | SBIRT |
| Health EducationSee Arm Description. | Behavioural | Health Education |
Primary outcome
Time Line Follow Back (TLFB)
Time frame: These data will be assessed for each 90-day period preceding the 3-, 6- and 12-month follow ups.
The TLFB will be used to determine days of use for alcohol and drugs over the 90-day period prior to the baseline assessment. The interviewer will guide the participant to identify the number of standard drinks consumed each day, starting from the day immediately before the assessment and moving backwards in time. Days on which cannabis and/or stimulants were used will also be queried. Variables calculated from the interview will include: (1) total standard drinks, (2) drinking frequency, (3) heavy-drinking frequency (5+ for men; 4+ for women), (4) maximum quantity of alcohol consumed, (5) number of days using cannabis, (6) number of days using cocaine, (7) number of days using methamphetamine, and (8) days on which any alcohol, cannabis or stimulant was used. This measure is completed at 3, 6 and 12 months post baseline in order to measure change from one timepoint to the next.
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 2 Nov 2018.
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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.
Mitch Karno, Ph.D. principal investigator
University of California, Los Angeles
Suzette Glasner-Edwards, Ph.D. principal investigator
University of California, Los Angeles
Richard Rawson, Ph.D. principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT and Health Education in people with Substance Use Disorders and Mental Illness, run by University of California, Los Angeles at 2 sites 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 6 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time Line Follow Back (TLFB) (time frame: These data will be assessed for each 90-day period preceding the 3-, 6- and 12-month follow ups.). 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 2 Nov 2018.