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Promoting Adherence to Treatment in Schizophrenia

Promoting Adherence to Treatment in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01125267
Enrollment
174
Registered
2010-05-18
Start date
2003-04-30
Completion date
2008-10-31
Last updated
2010-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

medication adherence, schizophrenia, Mexican American, multifamily groups

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

Interventions

BEHAVIORALmultifamily 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

BEHAVIORALmultifamily group-standard

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants who are Hospitalized in a Psychiatric Inpatient Unittwo yearsPsychiatric 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

MeasureTime frameDescription
Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment periodtwo yearsMulti-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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026