Promoting Adherence to Treatment in Schizophrenia

The project evaluates a culturally adapted, family-based intervention designed to promote treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled design in a public mental health setting. Mexican-American patients with schizophrenia and their families were randomly assigned to either: 1) one year of multi- family groups that emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived and actual adherence skills in maintaining adherence, added to ongoing customary outpatient care; 2) standard multi-family groups without an emphasis on medication adherence, added to customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy sessions and additional services as clinically needed). The study hypotheses are that subjects assigned to the adapted multi-family group would have better medication adherence, less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the study (one year of treatment and one year of follow up) compared to the comparison conditions.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: multifamily group-adherence; Behavioral: multifamily group-standard

Detailed Description

As above

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Granada Hills, California, United States, 91344
      • San Fernando Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder;
• Between 18 and 50 years of age;
• Of Mexican origin and speaks Spanish fluently;
• Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization;
• Was living with his/her family of origin immediately preceding the inpatient stay and would return to live with his/her family after discharge; and
• The patient and at least one family member were willing to participate.

Exclusion Criteria:

• Patient on conservatorship or legal guardian status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: treatment as usual
Experimental: multifamily group-adherence; multifamily group treatment with a focus on improving adherence to antipsychotic medication	Behavioral: multifamily group-adherence; multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior
Active Comparator: multifamily group-standard; multifamily group focused on problems identified by group participants	Behavioral: multifamily group-standard; multifamily groups held twice a month focused on general problem solving method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit	Psychiatric hospitalization will be monitored through the use of the Los Angeles County Department of Mental Health Management Information System. This allows for the data capture of all participants who are hospitalized in an inpatient unit anywhere in Los Angeles County throughout the two-yaer course of the study. Although the primary outcome variable is whether or not a participant has been hospitalized within a given assessment period, the number of hospitalizations and the number of days hospitalized across all assessment periods will be assessed, as well.	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period	Multi-modal method of assessing medication adherence including pill count, pharmacy records and interviews of patient, key relative and treating psychiatrist. Using the Treatment Compliance Interview, participants will be rated as either non-adherent (less than 50% adherence), partially adherent (50%-79% adherent) or fully adherent (80% or greater).	two years

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Alex J Kopelowicz, MD, Geffen School of Medicine at UCLA

Publications and helpful links

General Publications

• Kopelowicz A, Zarate R, Wallace CJ, Liberman RP, Lopez SR, Mintz J. The ability of multifamily groups to improve treatment adherence in Mexican Americans with schizophrenia. Arch Gen Psychiatry. 2012 Mar;69(3):265-73. doi: 10.1001/archgenpsychiatry.2011.135.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): May 18, 2010
• Last Update Submitted That Met QC Criteria: May 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: schizophrenia; medication adherence; Mexican American; multifamily groups
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 5R01MH064542-05 (U.S. NIH Grant/Contract)