Promoting Adherence to Treatment in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2008-10-31

Brief Summary

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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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Detailed Description

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As above

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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multifamily group-adherence

multifamily group treatment with a focus on improving adherence to antipsychotic medication

Group Type EXPERIMENTAL

multifamily group-adherence

Intervention Type 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

multifamily group focused on problems identified by group participants

Group Type ACTIVE_COMPARATOR

multifamily group-standard

Intervention Type BEHAVIORAL

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

treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

multifamily group-standard

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.