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Clinical Trials/NCT00980252
NCT00980252
Completed
Not Applicable

Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention

University of Illinois at Chicago1 site in 1 country34 target enrollmentNovember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Illinois at Chicago
Enrollment
34
Locations
1
Primary Endpoint
1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI).
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

Detailed Description

Overview: Many people recovering from first-episode schizophrenia typically respond very well to their initial course of antipsychotic medications; however, studies indicate that nonadherence rates soar as high as 90% in the first year and do not improve over time. To date, there is no effective psychosocial intervention that improves adherence or reduces the adverse consequences of nonadherence after it occurs. Thus, it is imperative to develop a new intervention to improve medication adherence and improve clinical outcomes in patients recovering from first-episode schizophrenia. This study is to pilot an intervention specifically suited for patients with first-episode schizophrenia based on the principles of Cognitive Behavioral Therapy (CBT). This is to focus on adherence from the perspective of the patient. Methods: This study compares the effectiveness of a standard psychoeducation program \[Team Solutions (TS)\] to a CBT approach known as the Health Dialogue Intervention (HDI). Consenting patients will receive a 4 week stabilization assessment period and then be randomized to a prospective, random-assignment study comparing the effectiveness of TS to HDI to improve medication adherence of patients recovering from first-episode schizophrenia.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
March 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Weiden

Professor

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI).

Time Frame: Completion of Study

Secondary Outcomes

  • 1. Compare the course of symptoms and relapse of patients in HDI to those in the TS.(Completion of Study)

Study Sites (1)

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