Clinical trial NCT01125267: Promoting Adherence to Treatment in Schizophrenia
Official title: Promoting Adherence to Treatment in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: medication adherence
schizophrenia
Mexican American
multifamily groups
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-18
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: As above

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit
timeFrame: two years
Secondary outcomes:
measure: Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period
timeFrame: two years
Other outcomes:
Locations:
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
Study officials:
affiliation: Geffen School of Medicine at UCLA
name: Alex J Kopelowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.