Back to resultsPromoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Enhancement Therapy
Enriched Supportive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Negative Symptoms, Cognition, Social Cognition
Eligibility Criteria
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.
Sites / Locations
- University of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Enhancement Therapy
Enriched Supportive Therapy
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04143126
First Posted
October 24, 2019
Last Updated
May 30, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04143126
Brief Title
Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
Official Title
Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Negative Symptoms, Cognition, Social Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 post-treatment follow-up (21 months) 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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Enhancement Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Enriched Supportive Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Enhancement Therapy
Other Intervention Name(s)
CET
Intervention Description
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
Intervention Name(s)
Enriched Supportive Therapy
Other Intervention Name(s)
EST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Persistent Negative Symptoms
Description
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.
Time Frame
Prior to treatment, 6 months, 12, months, 18 months, and 21 months
Secondary Outcome Measure Information:
Title
Change in Functioning
Description
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.
Time Frame
Prior to treatment, 6 months, 12, months, 18 months, and 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaun M Eack, PhD
Phone
412-246-5958
Email
sme12@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle M Perrin, MBA
Phone
412-683-7524
Email
perrinm@upmc.edu
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaun Eack, PhD
Email
sme12@pitt.edu
First Name & Middle Initial & Last Name & Degree
Shaun Eack, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The proposed study has a data sharing plan consistent with NIH policy. Data will be de-identified before sharing on a need to know basis. Sharing will be executed with an approved data transfer agreement.
IPD Sharing Time Frame
Final data that has not yet been published will be shared after acceptance of publication of the relevant paper.
IPD Sharing 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).
Learn more about this trial
Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
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