Psychotic Disorders, Schizophrenia
Conditions
Keywords
Schizophrenia, Cognitive Behavioral Therapy, Compliance, Medication Adherence, Psychotic Disorders, Mental Disorders, Outcomes, Psychoeducation, Adherence Attitudes, Intervention, Nonadherence, Schizophrenia and Disorders with Psychotic Features
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions
Sponsors
National Institute of Mental Health (NIMH)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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: 1. Between 16-45 years of age 2. A provisional clinical diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder in last 6 months 3. Discharge from inpatient unit for treatment of psychotic symptoms must have occurred in the last 6 months, or, if never hospitalized, initial treatment started in the last 6 months 4. Able to fully participate in the informed consent process 5. The patient is judged to be an appropriate candidate for ongoing outpatient follow-up at the First-episode Treatment Program at the Psychotic Disorders Program at UIC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | Completion of Study |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compare the course of symptoms and relapse of patients in HDI to those in the TS. | Completion of Study |
Countries
United States
Outcome results
None listed