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OpenTrials
Completed

NCT Number: NCT01125267

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.

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Key information

Conditions

Schizophrenia Behavior Health Behavior Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Fernando Mental Health Center

Granada Hills, California, 91344, United States

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multifamily group-adherence

Behavioral

multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior

multifamily group-standard

Behavioral

multifamily groups held twice a month focused on general problem solving method

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
May 18, 2010
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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