Promoting Adherence to Treatment in Schizophrenia
1 other identifier
interventional
174
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Apr 2003
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedMay 18, 2010
May 1, 2010
4.4 years
May 17, 2010
May 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period
two years
Study Arms (3)
multifamily group-adherence
EXPERIMENTALmultifamily group treatment with a focus on improving adherence to antipsychotic medication
multifamily group-standard
ACTIVE COMPARATORmultifamily group focused on problems identified by group participants
treatment as usual
NO INTERVENTIONInterventions
multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior
multifamily groups held twice a month focused on general problem solving method
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient on conservatorship or legal guardian status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Fernando Mental Health Center
Granada Hills, California, 91344, United States
Related Publications (1)
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.
PMID: 22393219DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex J Kopelowicz, MD
Geffen School of Medicine at UCLA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 18, 2010
Study Start
April 1, 2003
Primary Completion
September 1, 2007
Study Completion
October 1, 2008
Last Updated
May 18, 2010
Record last verified: 2010-05