Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia

Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia
often experience hallucinations, delusions, thought disorders, and movement disorders. These
symptoms make it difficult to maintain a job, participate in school, and keep up self-care.
Proper treatment of first-episode schizophrenia may increase the chances of controlling
disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and
psychosocial treatments, such as cognitive enhancement training and health behavior training,
are common, effective treatments for schizophrenia. This study will determine the
effectiveness of various combinations of psychosocial therapy and risperidone treatment in
improving work or school performance in people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive one of the
following four combinations of an antipsychotic medication and a psychosocial treatment:
cognitive enhancement training plus oral risperidone; cognitive enhancement training plus
long-acting injectable risperidone; health behavior training plus oral risperidone; or health
behavior training plus long-acting injectable risperidone. Cognitive enhancement training
will entail 2 hours per week of computer-assisted training targeted at improving attention,
memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour
group meeting to learn how to apply these skills to work and school situations. Health
behavior training will involve 3 hours per week of relaxation training, nutrition education,
and physical exercise to enhance wellness. Participants assigned to receive oral risperidone
will receive their medication in pill form at the dosage determined to be optimal by the
study psychiatrist. Participants assigned to receive injectable risperidone will be given one
injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as
needed.

Treatment will continue for 1 year following dosage stabilization, which typically occurs 2
to 3 months following study entry. For the first 6 months, participants assigned to receive
health behavior training will attend study visits once a week and participants assigned to
receive cognitive enhancement training will attend study visits twice a week. For the final 6
months, all participants will attend study visits twice weekly. At each visit, participants
will receive their assigned psychosocial treatment; attend group therapy; meet with a case
manager for counseling and assessment of symptoms, work functioning, and social functioning;
and meet with a psychiatrist to monitor medication response. Additional cognitive and health
behavior measures will be taken every 6 months to assess treatment effectiveness.

Inclusion Criteria:

- Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or
schizophreniform disorder

- First major episode of psychotic symptoms occurred within 2 years prior to study entry

Exclusion Criteria:

- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)

- Mental retardation (e.g., premorbid IQ less than 70)

- Significant alcohol or substance use during last 6 months

- Unable to complete research measures in English

- Any condition that may make risperidone use medically inadvisable