Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
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.
Conditions:
🦠 Schizophrenia
🗓️ Study Start (Actual) 1 October 2019
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 October 2019
  • First Submitted that Met QC Criteria 28 October 2019
  • First Posted 29 October 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 November 2023
  • Last Update Posted 22 November 2023
  • Last Verified November 2023