Screening, Brief Intervention and Referral to Treatment for Substance Abuse in Mental Health Treatment Settings

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

Inclusion Criteria. Participants who:

- (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.

Exclusion Criteria. Patients who:

- (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).