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

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.

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

Exclusion criteria for the Evaluation Phase:

1. Unable to understand informed consent process

2. A history of nonresponse to prior antipsychotic trials such that long-term inpatient
treatment or clozapine will be recommended

3. Prior treatment with clozapine

4. 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

5. Pregnancy or stated goal to become pregnant

6. Will not be living close enough to the medical center to return for follow-up visits
or assessments

7. History of geographic instability such that it is judged unlikely that patient will
reside in the area

8. Currently under arrest for a felony, or an arrest is deemed likely in the near future

9. Currently receiving medication over objection by court order

10. Currently receiving treatment in another research protocol

Inclusion Criteria for the Treatment Intervention Phase:

1. Willingness to transition to receive evaluation and future pharmacologic treatment at
the Psychotic Disorders Program at UIC

2. Has capacity to understand the risks and benefits of participating in a randomized
psychosocial trial

3. Willingness to sign informed consent to go into the Treatment Intervention Phase

4. 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

5. Is willing to have therapy sessions recorded for fidelity assessments

6. 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:

1. Diagnosis or inpatient treatment for psychotic symptoms occurred more than 6 months
from date of enrollment into evaluation phase

2. Acutely psychotic individuals may not participate because therapy will not benefit if
symptoms are too severe

3. Has dropped out of the treatment program and cannot be located for follow-up
appointments

4. 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

5. Judged to be at significant and imminent risk of harm to self or others*

6. 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

7. Remains enrolled in another research protocol at UIC*

8. Unwilling to consider any additional psychotherapeutic intervention above and beyond
coming in to the service for medication management appointment

9. 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)*

10. Judged to require additional concrete case management services to support medication
adherence*

11. 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.