Improving cognitive and social skills in schizophrenia patients
Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia
This study is testing two new therapy approaches to see if they can help improve thinking and social skills in people with schizophrenia who have ongoing negative symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04143126 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of two innovative psychosocial interventions, Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST), for treating persistent negative symptoms in individuals with schizophrenia. A total of 90 outpatients aged 18-60 with moderate-to-severe negative symptoms will be randomly assigned to receive either CET or EST over an 18-month period. The study will collect extensive data on symptoms, cognition, and functional outcomes at baseline and every six months to assess the efficacy of these therapies and their long-term effects.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18-60 with a diagnosis of schizophrenia or schizoaffective disorder and persistent negative symptoms lasting at least three months.
Not a fit: Patients with acute exacerbations of schizophrenia or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients with schizophrenia by reducing negative symptoms and enhancing cognitive function.
How similar studies have performed: Previous studies have shown promise in using psychosocial interventions for schizophrenia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Shaun M Eack, PhD
- Email: sme12@pitt.edu
- Phone: 412-246-5958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.