Status:
COMPLETED
Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
16-45 years
Phase:
NA
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 tra...
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 so...
Eligibility Criteria
Inclusion
- 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:
- Between 16-45 years of age
- A provisional clinical diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder in last 6 months
- 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
- Able to fully participate in the informed consent process
- 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
- Exclusion criteria for the Evaluation Phase:
- Unable to understand informed consent process
- A history of nonresponse to prior antipsychotic trials such that long-term inpatient treatment or clozapine will be recommended
- Prior treatment with clozapine
- Discharge from inpatient treatment for psychotic symptoms, initial treatment, or provisional diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform occurred more than 6 months from enrollment into the evaluation phase
- Pregnancy or stated goal to become pregnant
- Will not be living close enough to the medical center to return for follow-up visits or assessments
- History of geographic instability such that it is judged unlikely that patient will reside in the area
- Currently under arrest for a felony, or an arrest is deemed likely in the near future
- Currently receiving medication over objection by court order
- Currently receiving treatment in another research protocol
- Inclusion Criteria for the Treatment Intervention Phase:
- Willingness to transition to receive evaluation and future pharmacologic treatment at the Psychotic Disorders Program at UIC
- Has capacity to understand the risks and benefits of participating in a randomized psychosocial trial
- Willingness to sign informed consent to go into the Treatment Intervention Phase
- Is able to complete a post-test for understanding the nature of the study and what it entails, and the potential risks and benefits of study participation
- Is willing to have therapy sessions recorded for fidelity assessments
- Is willing to receive follow-up independent assessments of adherence status, including separate interviews with trained independent raters, and our contacting the outpatient pharmacy for pharmacy refill records
- Exclusion criteria for Treatment Intervention Phase:
- Diagnosis or inpatient treatment for psychotic symptoms occurred more than 6 months from date of enrollment into evaluation phase
- Acutely psychotic individuals may not participate because therapy will not benefit if symptoms are too severe
- Has dropped out of the treatment program and cannot be located for follow-up appointments
- Stated refusal to come for to at least one clinical evaluation appointment at the PDP, or has been a "no show" for at least three consecutive appointments
- Judged to be at significant and imminent risk of harm to self or others\*
- Ongoing active substance or alcohol use that is not controlled during the Evaluation Phase, along with refusal of referral to a "dual diagnosis" treatment program for substance abuse problems
- Remains enrolled in another research protocol at UIC\*
- Unwilling to consider any additional psychotherapeutic intervention above and beyond coming in to the service for medication management appointment
- Baseline PANSS total score ≥ 90, or has a individual PANSS item of conceptual disorganization (item P2), excitement (P4), or hostility (P7) that is ≥ 5 (moderately severe)\*
- Judged to require additional concrete case management services to support medication adherence\*
- Receives antipsychotics under coercive conditions (e.g. inpatient or outpatient commitment)\*
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00980252
Start Date
November 1 2009
End Date
March 1 2013
Last Update
June 16 2014
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612