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Active, Not Recruiting

NCT Number: NCT04143126

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and:

  • are between 18-60 years of age;
  • have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
  • have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
  • have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
  • have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
  • have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
  • have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
  • have had changes to their primary antipsychotic medication within the previous 3 months;
  • have current IQ > 80; and
  • 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:

  • the presence of organic brain syndrome;
  • comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
  • persistent suicidal or homicidal behavior;
  • significant clinician-estimated medication non-adherence; and
  • SCID-verified substance use disorder.

Treatment and study plan

Cognitive Enhancement Therapy

Behavioral

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.

Other names: CET

Enriched Supportive Therapy

Behavioral

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.

Other names: EST

Primary outcomes

  1. Change in Persistent Negative Symptoms

    Time frame: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

    Negative symptoms will be assessed using the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a structured interview measure of expressive and motivational negative symptoms consisting of 13 items based on a standardized interview with anchor points for each rating. This measure was developed to address the limitations of previous negative symptom measures and designed for use in clinical trials of negative symptom therapeutics. This outcome has two endpoints that will be evaluated in this trial, persistent negative symptoms related to expression (Expression subscale) and persistent negative symptoms related to motivation/pleasure (Motivation/Pleasure subscale). Items are rated on a 0 to 4 scale, with higher scores indicating greater negative symptom severity.

Secondary outcomes

  1. Change in Functioning

    Time frame: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

    A composite index of functional outcomes will be derived from measures of social adjustment commonly used in schizophrenia research. These are clinical interview-based measures of functioning, with some self-report measures, covering vocational, social, family, and other functional outcome domains. Measures will include the Social Adjustment Scale-II, Major Role Adjustment Inventory, the Global Assessment of Functioning, and other field standards of functional outcome in schizophrenia. Because these measures do not share a common Unit of Measure and because of the large number of functional outcome measures used, a composite index will be formed to assess changes in functioning to reduce Type I error from multiple inference testing.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2019
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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