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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00980252 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Psychotic Disorders |
Behavioral: Cognitive Behavioral Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT
UK-based intervention
|
Behavioral: Cognitive Behavioral Therapy
Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
There is a 2 step inclusion/exclusion criteria, the first being for assessing overall eligibility to enter the study, and then, for continued outpatient treatment for schizophrenia, schizophreniform disorder, or schizoaffective disorder.
Inclusion criteria for entry into the Evaluation Phase:
Exclusion criteria for the Evaluation Phase:
Inclusion Criteria for the Treatment Intervention Phase:
Exclusion criteria for Treatment Intervention Phase:
Note: The exclusion criteria (*) may be present during some parts of the Evaluation Phase and would need to be resolved within the 4 week time period permitted for the Evaluation Phase prior to the Treatment Intervention Phase of study entry.
Contacts and Locations| United States, Illinois | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Kasia Liwski, B.S. 312-996-8164 psi@psych.uic.edu | |
| Contact: Emily Sumner, M.A. (312) 996-8164 psi@psych.uic.edu | |
| Principal Investigator: Peter Weiden | |
| Principal Investigator: | Peter J. Weiden, M.D. | University of Illinois |
More Information
| Responsible Party: | Peter J. Weiden, M.D., University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT00980252 History of Changes |
| Other Study ID Numbers: | R34 MH080978, R34MH080978-01A2, DSIR 83-AT |
| Study First Received: | September 18, 2009 |
| Last Updated: | March 26, 2010 |
| Health Authority: | United States: Federal Government |
|
Schizophrenia Cognitive Behavioral Therapy Compliance Medication Adherence Psychotic Disorders Mental Disorders |
Outcomes Psychoeducation Adherence Attitudes Intervention Nonadherence Schizophrenia and Disorders with Psychotic Features |
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features |