Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

NCT04143126 | Active Not Recruiting

• 2 other identifiers: STUDY19050382R01MH118267
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Negative Symptoms; Cognition; Social Cognition

Outcome Measures

Primary Outcomes (1)

• Change in Persistent Negative Symptoms

  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.

  Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Secondary Outcomes (1)

• Change in Functioning

  Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Study Arms (2)

Cognitive Enhancement Therapy

EXPERIMENTAL

This research treatment aims to help with problems in thinking, planning, and socialization. Participants begin with cognitive training using computer software programs. They also participate in a small social-cognitive group to learn about their condition and how to act wisely in social situations by developing the abilities needed to understand another person's perspective, evaluate social contexts, and be foresightful. Time commitment: about 3½ hours per week; Location: Pittsburgh, PA only

Behavioral: Cognitive Enhancement Therapy

Enriched Supportive Therapy

ACTIVE COMPARATOR

This research treatment 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. Time commitment: about 2 hours per week; Location: Pittsburgh, PA only

Behavioral: Enriched Supportive Therapy

Interventions

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.

Also known as: CET

Cognitive Enhancement Therapy

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.

Also known as: EST

Enriched Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This proposed study consists of an 18-month randomized-controlled trial in which 90 outpatients with schizophrenia with moderate-to-severe persistent negative symptoms will be randomized to Cognitive Enhancement Therapy (CET) or Enriched Supportive Therapy (EST) and treated for 18 months. Comprehensive measures of cognition, negative symptoms, and functional outcome will be collected prior to treatment, every 6-months thereafter (6 and 12 months), at treatment completion (18 months), and 3-month (21 months) and one year (30 months) post-treatment follow-up to provide a rigorous confirmatory test of the efficacy of CET and EST for patients with persistent negative symptoms and the cognitive mechanisms of negative symptom improvement in the disorder.

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 1, 2019
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final data that has not yet been published will be shared after acceptance of publication of the relevant paper.
• Access Criteria: Data sharing will occur at two levels:1) specific requests to analyze data from investigators in the field and 2) collaboration with NIH to facilitate data sharing activities for the NIMH National Database for Clinical Trials Related to Mental Illness (NDCT).

Locations

US (1)