An eight-week study with baseline, 2-month, 6-month, and 12 month follow-up assessments, in which dually diagnosed patients who meet inclusion criteria and sign informed consent will be randomly assigned to one of two groups: one group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group), or to a group that receives treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). The length of the health education sessions (four group session and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging. Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition. Comparison between the TLC (treatment group) and health education group (control group) will be examined via the following hypothesizes:

Hypothesis # 1: To further evaluate the impact of the TLC intervention in helping transition individuals from an Acute Psychiatry Day Treatment.

Hypothesis 2: Individuals in the TLC group will have larger improvements on the Global Assessment of Functioning (GAF) compared to those in the control group.

Hypothesis #3: Individuals in the TLC group will have reduced substance use and fewer relapses compared to controls.

Hypothesis #4: Individuals in TLC group will make greater improvements than the control group in other significant life domains, including medical status, family/social adjustment, employment and criminal justice involvement.

Condition	Intervention
Schizophrenia Psychotic Disorders Substance-Related Disorders Bipolar Disorder	Behavior: Time limited case management  Behavior: Health Education

Further Study Details: 

Primary Outcomes: Show rate at outpatient day treatment center within one week post–hospitalization. Differences in TLC group completion at 2 months. Number of day treatment attended at 6 month and 12 months. Number days re-hospitalized at 6 month and 12 month.
Secondary Outcomes: Global Level of Functioning at 2 months, 6 month and 12 months. Number of days alcohol use at 2 months, 6 months, 12 months Number of days drug use at 2 months, 6 months, 12 months
Expected Total Enrollment:  170

Substance abuse is common among individuals with serious mental illnesses (SMI) and often contributes to poor treatment outcome and high attrition. Local and national data suggest that treatment attrition frequently occurs when dually diagnosed individuals transition from in-patient hospital settings to outpatient treatment. To address this vulnerable period, improve longer term treatment outcomes and reduce costly inpatient treatment days, we developed an 8-week community linkage intervention, called Time-Limited Case Management (TLC) to assist in transitioning individuals from acute inpatient to outpatient services. The rationale for the development of a short-term approach to address this problem stems from the observation that many dually diagnosed patients have different needs from non-substance abusing SMI individuals. For example, dually diagnosed patients are often higher functioning with more sophisticated social skills, but are less treatment compliant; treatment non-compliance and substance abuse, often precipitates symptom exacerbations, instability and re-hospitalization. Such patients are likely to benefit from brief interventions that facilitate community and outpatient treatment engagement yet, unlike the more functionally impaired they often do not need indefinite support once they have made a successful transition to the community.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Male and female patients over 18 years old.
2. Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder.
3. Patients seeking outpatient treatment for the above disorders from the VA.
4. Physically mobile
5. Agree to take public transportation if they do not have other private sources.

Exclusion Criteria:

1. Patients who only have either a mental health problem, or a substance abuse problem, but not both.
2. Patients who do not have a residence where they can stay upon discharge from the hospital.
3. Patients who are not sufficiently medically or psychiatrically stable to participate in residential or outpatient treatment. Those patients could be re-evaluated for the study once stabilized.
4. Patients exclusively engaged in methadone maintenance programs.
5. Patients who represent a serious suicide risk.

Please refer to this study by ClinicalTrials.gov identifier  NCT00137267

New Jersey
      VA New Jersey Health Care System, East Orange, East Orange,  New Jersey,  07018,  United States; Recruiting

Study chairs or principal investigators

David A. Smelson, PSYD,  Principal Investigator,  VA New Jersey Health Care System, East Orange   

Study ID Numbers:  IIR 02-145
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137267
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30