Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder

Depression Clinical Trial

Official title:

The STIRR Intervention for Dually Diagnosed Clients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316303
• Other study ID #: R01MH072556
• Secondary ID: R01MH072556DAHBR
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2006
• Last updated: April 4, 2013
• Start date: February 2006
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.

Description:

People who have been dually diagnosed with a severe mental illness and a substance abuse disorder are at an elevated risk for contracting blood-borne infections, such as HIV, hepatitis B, and hepatitis C virus (HCV). Prevention, early detection, and treatment for these diseases are essential for this particular population. Research has shown that rates of HCV infection are 11 times higher in people with mental illnesses than in the general population. People with mental health illnesses and those with dual diagnoses should receive basic CDC-recommended services for risk screening and testing of HIV infection, AIDS, and hepatitis. They should also receive hepatitis A and B immunizations, risk reduction counseling, and referrals for medical care. However, most people with severe mental illnesses and substance abuse disorders do not receive the care they need. The STIRR (screen, test, immunize, reduce risk, and refer) intervention will provide necessary prevention and treatment services to an at-risk, under-treated population. This study will determine the effectiveness of the STIRR intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.

Participants in this open-label study will be recruited from two publicly funded community mental health agencies in Baltimore, MD. Participants will be randomly assigned to receive either enhanced treatment as usual or the STIRR intervention. Individuals assigned to STIRR will attend three sessions over the course of 6 months. The first session will involve education, personalized risk assessment, risk reduction counseling, pre-test counseling, blood testing, and an initial immunization with Twinrix for hepatitis A and B viruses (HAV and HBV). At the second session, participants will receive their test results, as well as post-test and risk reduction counseling, medical referral and linkage, if necessary, and a second Twinrix immunization. The third session will include an assessment of risk level and reinforcement of risk reduction, a final immunization, an assessment of progress on treatment and linkage, and behavior reinforcement or modification. Enhanced treatment as usual will entail comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments. All participants will be assessed for treatment outcomes at Month 6. A 12-month post-intervention follow-up will be carried out with the infected participants in the STIRR group to evaluate quality of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression

• Diagnosis of a substance use disorder

• Enrolled in clinical care at Creative Alternatives or People Encouraging People for at least 3 months

Exclusion Criteria:

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• HIV Infections
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Twinrix
This vaccine will be given in three parts: at entry and after 3 and 6 months.

Behavioral:
• Enhanced treatment as usual
Participants will receive comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.

Locations

Country	Name	City	State
United States	University of Maryland, Department of Psychaitry	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Rosenberg S, Brunette M, Oxman T, Marsh B, Dietrich A, Mueser K, Drake R, Torrey W, Vidaver R. The STIRR model of best practices for blood-borne diseases among clients with serious mental illness. Psychiatr Serv. 2004 Jun;55(6):660-4. — View Citation

Rosenberg SD, Drake RE, Brunette MF, Wolford GL, Marsh BJ. Hepatitis C virus and HIV co-infection in people with severe mental illness and substance use disorders. AIDS. 2005 Oct;19 Suppl 3:S26-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Immunization Status	Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.	Measured at 6 Months relative to Baseline	No
Primary	Tested for Hepatitis C	Participant self-report of being tested for hepatitis C	6 Months	No
Primary	Tested for Hepatitis B	Participant self-report of being tested for hepatitis B	6 Months	No
Primary	Tested for HIV	Participant self-report of being tested for HIV	6 Months	No
Primary	Referral for Medical Care	For participants infected with hepatitis C, their self-report of being referred for medical care.	6 Months	Yes