Contingency Management of Alcohol Abuse in the Severely Mentally ILL (CMETG)

University of Washington

Status

Completed

Conditions

Major Depressive Disorder

Schizophrenia

Bipolar Disorder

Alcohol Abuse

Treatments

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other

Identifiers

NCT01567943

41552-G

Details and patient eligibility

About

The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.

Full description

The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions.

The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.

Enrollment

123 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
Aged 18 to 65 years.
Ability to understand written and spoken English language.
DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview.
Alcohol use in the month prior to study entry: self-reported alcohol use of 5 days or more during the 30 days prior to study entry (5 drinking days/month is selected based on previous research reporting alcohol use in 18% of days assessed in a sample of psychiatric outpatients with co-occurring SUDs & SMI).120
A CPC treating clinician must affirm the potential participant is safe to participate in the study.

Exclusion criteria

A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal.
DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
Chart defined organic brain disorder or dementia.
Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.