Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

NCT ID: NCT04143126

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2026-06-30

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.

Detailed 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Enhancement Therapy

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

Group Type: EXPERIMENTAL

Cognitive Enhancement Therapy

Intervention Type: 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.

Enriched Supportive Therapy

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

Group Type: ACTIVE_COMPARATOR

Enriched Supportive Therapy

Intervention Type: 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.

Interventions

Cognitive Enhancement Therapy

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.

Intervention Type: BEHAVIORAL

Enriched Supportive Therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CET; EST

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Shaun M. Eack

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shaun M Eack, PhD

Role: CONTACT

sme12@pitt.edu

412-246-5958

Michelle M Perrin, MBA

Role: CONTACT

perrinm@upmc.edu

412-683-7524

Facility Contacts

Shaun Eack, PhD

Role: primary

sme12@pitt.edu

Other Identifiers

R01MH118267

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19050382

Identifier Type: -

Identifier Source: org_study_id