Contingency Management of Alcohol Abuse in the Severely Mentally ILL
Status: | Completed |
---|---|
Conditions: | Depression, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 7/11/2015 |
Start Date: | March 2012 |
End Date: | March 2015 |
Contact: | Michale G McDonell, Ph. D. |
Phone: | 206-744-9971 |
Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
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.
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.
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.
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.
Inclusion Criteria:
1. Currently receiving psychiatric [AND intensive outpatient addiction treatment] at
Community Psychiatric Clinic (CPC).
2. Aged 18 to 65 years.
3. Ability to understand written and spoken English language.
4. DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
5. 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.
6. 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
7. A CPC treating clinician must affirm the potential participant is safe to participate
in the study.
Exclusion Criteria:
1. 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.
2. DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI
interview.
3. Any medical/psychiatric condition, or severity of that condition, that in the opinion
of the PI, would compromise safe study participation.
4. Chart defined organic brain disorder or dementia.
5. 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.
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