SchizophreniaNCT04143126

Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

A study testing Cognitive Enhancement Therapy and Enriched Supportive Therapy in people with Schizophrenia, run by University of Pittsburgh at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Schizophrenia
What is being tested?: Cognitive Enhancement Therapy and Enriched Supportive Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Show all 11Show fewer

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. -

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia

Read the 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
Being tested: Cognitive Enhancement Therapy, Enriched Supportive Therapy
Keywords: Negative Symptoms, Cognition, Social Cognition
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Enhancement TherapyBehavioural
Also called CET
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 TherapyBehavioural
Also called EST
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.

Study groups in NCT04143126
Study group	Role	What they receive
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 Receives: 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 Receives: Behavioral: Enriched Supportive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Secondary outcomes (1)

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.
Measured: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201930 Jun 2027

First posted29 Oct 2019
Study start1 Oct 2019
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 (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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143126
Sponsor's protocol ID: STUDY19050382
Other IDs: R01MH118267
Status last verified: Apr 2026
First submitted: 24 Oct 2019
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia
ClinicalTrials.gov ID: NCT04143126
Acronym / sponsor ID: STUDY19050382
Conditions: Schizophrenia
Keywords: Negative Symptoms, Cognition, Social Cognition
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Oct 2019 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 29 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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 (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.

Arm	Type	Receives
Cognitive Enhancement Therapy	Experimental	Behavioral: Cognitive Enhancement TherapyThis 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
Enriched Supportive Therapy	Active comparator	Behavioral: Enriched Supportive TherapyThis 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

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Enhancement TherapyAlso: CETAn 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.	Behavioural	Cognitive Enhancement Therapy
Enriched Supportive TherapyAlso: ESTAn 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.	Behavioural	Enriched Supportive Therapy

Primary outcome

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.

1 secondary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Enhancement Therapy and Enriched Supportive Therapy in people with Schizophrenia, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Persistent Negative Symptoms (time frame: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.