Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention
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|ClinicalTrials.gov Identifier: NCT00980252|
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : June 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychotic Disorders||Behavioral: Cognitive Behavioral Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
Behavioral: Cognitive Behavioral Therapy
Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions
- 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 ]
- 1. Compare the course of symptoms and relapse of patients in HDI to those in the TS. [ Time Frame: Completion of Study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980252
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Peter J. Weiden, M.D.||University of Illinois at Chicago|