Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

Last updated: November 4, 2024
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

Enriched Supportive Therapy

Cognitive Enhancement Therapy

Clinical Study ID

NCT04143126
STUDY19050382
R01MH118267
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 asidentified from the medical record;

  4. have observed persistent negative symptoms at the beginning and end of the 4-weekevaluation 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-weekevaluation period;

  7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-weekevaluation period;

  8. have had changes to their primary antipsychotic medication within the previous 3months;

  9. have current IQ > 80; and

  10. are able to read (sixth grade level or higher) and speak fluent English. -

Exclusion

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.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Enriched Supportive Therapy
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
June 30, 2025

Study Description

This project will conduct a confirmatory efficacy trial to examine the efficacy of Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST) for the treatment of schizophrenia patients with significant and persistent negative symptoms. A total of 90 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of CET or EST. Comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of CET and EST for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of CET and EST effects on negative symptoms and functioning.

Connect with a study center

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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