Promoting Adherence to Treatment in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01125267
First received: May 17, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention
Schizophrenia
Behavioral: multifamily group-adherence
Behavioral: multifamily group-standard

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Adherence to Treatment in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit [ Time Frame: two years ] [ Designated as safety issue: No ]
    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:
  • Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period [ Time Frame: two years ] [ Designated as safety issue: No ]
    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).


Enrollment: 174
Study Start Date: April 2003
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

As above

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125267

Locations
United States, California
San Fernando Mental Health Center
Granada Hills, California, United States, 91344
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Alex J Kopelowicz, MD Geffen School of Medicine at UCLA
  More Information

No publications provided

Responsible Party: Alex Kopelowicz, M.D., David Geffen School of Medicine at UCLA
ClinicalTrials.gov Identifier: NCT01125267     History of Changes
Other Study ID Numbers: 5R01MH064542-05, 5R01MH064542-05
Study First Received: May 17, 2010
Last Updated: May 17, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 21, 2014