Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia
Overview
- Phase
- Phase 4
- Intervention
- Cognitive remediation training (CT)
- Conditions
- Schizophrenia
- Sponsor
- University of California, Los Angeles
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Average Medication Non-adherence
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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 once 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.
Investigators
Keith Nuechterlein, Ph.D.
Prinicipal Investigator
University of California, Los Angeles
Eligibility Criteria
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 intelligence quotient (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
Arms & Interventions
Cog Remediation, risperidone injection
Participants will receive cognitive remediation training plus risperidone, administered via injection.
Intervention: Cognitive remediation training (CT)
Cog Remediation, risperidone injection
Participants will receive cognitive remediation training plus risperidone, administered via injection.
Intervention: Risperidone, administered via injection (RLAI)
Healthy Behavior Training, risperidone injection
Participants will receive health behavior training plus risperidone, administered via injection.
Intervention: Healthy behavior training (HBT)
Healthy Behavior Training, risperidone injection
Participants will receive health behavior training plus risperidone, administered via injection.
Intervention: Risperidone, administered via injection (RLAI)
Cog Remediation, oral risperidone
Participants will receive cognitive remediation training plus risperidone administered orally.
Intervention: Cognitive remediation training (CT)
Cog Remediation, oral risperidone
Participants will receive cognitive remediation training plus risperidone administered orally.
Intervention: Risperidone, administered orally (Oral Ris)
Healthy Behavior Training, oral risperidone
Participants will receive health behavior training plus risperidone administered orally.
Intervention: Healthy behavior training (HBT)
Healthy Behavior Training, oral risperidone
Participants will receive health behavior training plus risperidone administered orally.
Intervention: Risperidone, administered orally (Oral Ris)
Outcomes
Primary Outcomes
Average Medication Non-adherence
Time Frame: Averaged over study participation (up to 12 months)
5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time Frame: Measured at baseline and 12 months
Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.
Work/School Functioning (Global Functioning Scale: Role)
Time Frame: Baseline to 12 months
Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.
Secondary Outcomes
- Work Behavior Inventory (WBI) Quality of Work/School Performance(Baseline to 1 year)
- Maintenance of Work/School Attendance(12 months)
- Retention in Treatment(12 months)
- Change in Coping Strategies(Baseline to 12 months)
- Exacerbation or Relapse of Psychotic Symptoms(Occurence after randomization and until end of study participation (up to 12 mos.))
- Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)(12 months after randomization)
- Change in Motivation for Work/School(Baseline to 12 months)