Promoting Adherence to Treatment in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125267
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
National Institute of Mental Health (NIMH)
Information provided by:
University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: multifamily group-adherence Behavioral: multifamily group-standard Not Applicable

Detailed Description:
As above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Adherence to Treatment in Schizophrenia
Study Start Date : April 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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
No Intervention: treatment as usual

Primary Outcome Measures :
  1. Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit [ Time Frame: two years ]
    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.

Secondary Outcome Measures :
  1. Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period [ Time Frame: two years ]
    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).

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01125267

United States, California
San Fernando Mental Health Center
Granada Hills, California, United States, 91344
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Alex J Kopelowicz, MD Geffen School of Medicine at UCLA

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alex Kopelowicz, M.D., David Geffen School of Medicine at UCLA Identifier: NCT01125267     History of Changes
Other Study ID Numbers: 5R01MH064542-05 ( U.S. NIH Grant/Contract )
5R01MH064542-05 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by University of California, Los Angeles:
medication adherence
Mexican American
multifamily groups

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders