Integrating Combined Therapies for Persons With Co-occurring Disorders

The proposed study will evaluate the effectiveness and implementability of a manual-guided
integrated psychosocial treatment, Integrating Combined Therapies (ICT). ICT is an adaptation
of the Combined Behavioral Intervention (CBI) from NIAAA Project COMBINE, and expands CBI's
indication for alcohol problems to extend to drug use and the most common psychiatric
problems in addiction treatment. ICT is designed to be transferable to routine care settings
and for delivery by the existing workforce. Findings from a 2014 study provide a signal for
ICT effectiveness and implementation.

We intend to randomly assign 76 eligible patients in outpatient addiction treatment to ICT
adapted standard care (ICT+SC) versus standard care only (SC). There are 2 specific aims for
this study:

Aim 1: Relative to standard care alone, to evaluate if patients receiving ICT have more
significant reductions in alcohol use and severity as measured by the 90-day Timeline Follow
Back (TLFB), Addiction Severity Index (ASI), and Short Inventory of Problems (SIP).

Aim 2: Relative to standard care alone, to evaluate if patients receiving ICT have more
significant reductions in psychiatric symptom severity, as measured by the Brief Symptom
Inventory (BSI) adn the ASI psychiatric severity composite.

This study involves a two-group repeated measure design. This study is a randomized
controlled trial. The investigators plan to examine the outcomes associated with ICT versus
standard care among patients receiving outpatient addiction treatment services. The
investigators will employ assessments at baseline, four-month follow-up, and seven-month
follow-up. Eligible participants will be randomly assigned to ICT therapy (plus standard
care) or standard care, and all will be followed for the research assessments regardless of
whether they drop out of treatment early (whenever possible).

Patients admitted to the participating addiction treatment program are routinely screened for
an alcohol use disorder using the AUDIT and a mental health disorder using the MMS. These
forms are collected by clinic staff and scored for alcohol use disorder (AUDIT: 8 or greater)
and mental health disorder (MMS: 6 or greater). Patients meeting the threshold criteria on
the AUDIT and MMS measures are approached by clinic staff about potential interest in the
study. If they wish to learn more about the study, the research assistant is contacted, a
suitable time is arranged, and the patient engaged in the process of informed consent.

If consent is granted, the participant completes the baseline assessment. The baseline
assessment consists of measures gathered via interview by a member of the research team,
self-administered surveys completed directly by the participant, and review of the
participant's medical record to extract substance use, treatment history, and chart
diagnoses.

The interview portion of the assessment consists of :

- Standardized interview designed to assess mental health diagnoses: Structured Clinical
Interview for DSM5 (SCID).

- A urine screen and breathalyzer to test for alcohol and other drugs.

- Standardized follow-back method for gathering data on recent alcohol and drug use:
Timeline Follow-back calendar (TLFB)

The self-administered portion of the assessment consists of measures designed to assess:

- Alcohol and drug use, as well as associated problems in other life areas such as
medical, employment, legal, social, and psychiatric: Addiction Severity Index

- Psychiatric symptoms: Brief Symptom Inventory (BSI)

- Mental health disorders: Modified MINI Screen (MMS)

- Negative consequences of alcohol and substance use: Short Inventory of Problems- Alcohol
and Drugs (SIP-AD)

- Substance use symptoms and problems: Brief Addiction Monitor (BAM)

- Treatment utilization: Recent Treatment Survey (RTS)

If the participant continues to meet criteria for a mental health disorder (i.e. SCID
interview confirms diagnosis of DSM5 mental health disorder, he or she is randomized to
receive the study ICT therapy or standard care (SC)

Research assessments are then also conducted at four months and seven months post baseline
assessment. The follow-up assessments will consist of the same measures administered at
baseline, with the exception of the SCID interview.

The investigators plan to randomize approximately 76 participants in the study.

Inclusion Criteria:

1. At least 18 years old;

2. Evaluated and admitted to outpatient addiction treatment services at RMHS Evergreen
program and meets criteria for any alcohol or substance use disorder;

3. Screened positive for an alcohol problem on the Alcohol Use Disorders Identification
Test (AUDIT) (score of 8 or higher) (screening instrument);

4. Screened positive for a mental health problem on the Modified MINI Screen (MMS) (score
of 6 or higher) (screening instrument);

5. Diagnoses confirmed by SCID (diagnostic interview); AND

6. Willing and able to provide informed consent.

Exclusion Criteria:

1. They have acute psychotic symptoms and are not appropriately connected with mental
health services;

2. They have had a psychiatric hospitalization or suicide attempt within the past month
(however, if the hospitalization or attempt was directly related to substance
intoxication or detoxification and the person is currently stable, they are eligible);
OR

3. They have unstable medical or legal situations that would make participation for the
full duration of the study highly unlikely.