NCT01883791

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

4.3 years

First QC Date

November 30, 2012

Last Update Submit

October 31, 2018

Conditions

Keywords

substance abuse prevention and treatmentcomorbiditySBIRT

Outcome Measures

Primary Outcomes (1)

  • 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.

    These data will be assessed for each 90-day period preceding the 3-, 6- and 12-month follow ups.

Study Arms (2)

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.

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.

Behavioral: Health Education

Interventions

SBIRTBEHAVIORAL

See above Arm description.

Also known as: Screening, Brief Intervention and Referral to Treatment.
SBIRT

See Arm Description.

Health Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Inpatient and Outpatient Psychiatric Units

Los Angeles, California, 90025, United States

Location

Ventura County Behavioral Health

Oxnard, California, 93036, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersMental Disorders

Interventions

Mass ScreeningCrisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mitch Karno, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Suzette Glasner-Edwards, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Richard Rawson, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychologist

Study Record Dates

First Submitted

November 30, 2012

First Posted

June 21, 2013

Study Start

March 1, 2013

Primary Completion

June 30, 2017

Study Completion

June 30, 2018

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations