Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

Schizophrenia Clinical Trial

Official title:

Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143126
• Other study ID #: STUDY19050382
• Secondary ID: R01MH118267
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Shaun M Eack, PhD
• Phone: 412-246-5958
• Email: sme12[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Functioning	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.	Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months