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RECRUITINGINTERVENTIONAL

Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.

Who May Be Eligible (Plain English)

Who May Qualify: Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and: 1. are between 18-60 years of age; 2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID; 3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record; 4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period; 5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period; 6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period; 7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period; 8. have had changes to their primary antipsychotic medication within the previous 3 months; 9. have current IQ \> 80; and 10. are able to read (sixth grade level or higher) and speak fluent English. - Who Should NOT Join This Trial: Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include: 1. the presence of organic brain syndrome; 2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness); 3. persistent suicidal or homicidal behavior; 4. significant clinician-estimated medication non-adherence; and 5. SCID-verified substance use disorder. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and: 1. are between 18-60 years of age; 2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID; 3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record; 4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period; 5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period; 6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period; 7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period; 8. have had changes to their primary antipsychotic medication within the previous 3 months; 9. have current IQ \> 80; and 10. are able to read (sixth grade level or higher) and speak fluent English. - Exclusion Criteria: Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include: 1. the presence of organic brain syndrome; 2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness); 3. persistent suicidal or homicidal behavior; 4. significant clinician-estimated medication non-adherence; and 5. SCID-verified substance use disorder.

Treatments Being Tested

BEHAVIORAL

Cognitive Enhancement Therapy

An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.

BEHAVIORAL

Enriched Supportive Therapy

An 18-month intervention that uses individual supportive therapy to help patients learn about schizophrenia, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies.

Locations (1)

University of Pittsburgh
Pittsburgh, Pennsylvania, United States