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Behavioral Intervention

Cognitive and Activity Therapies for Schizophrenia

N/A

Recruiting

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period

have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period

Must not have

comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness)

the presence of organic brain syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Awards & highlights

Summary

This trial will test two new therapies for treating negative symptoms in schizophrenia, which may improve cognition and daily functioning.

Who is the study for?

The PACES trial is for outpatients aged 18-60 with schizophrenia or schizoaffective disorder, having persistent negative symptoms for at least 3 months. Participants must be stable on antipsychotic meds, have an IQ over 80, and read/speak English well. Excluded are those with cognitive impairments from medical conditions, substance use disorders, or significant medication non-adherence.

What is being tested?

This study tests two psychosocial treatments: Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST), aiming to improve persistent negative symptoms in schizophrenia patients. The effectiveness of these novel interventions will be compared through this confirmatory efficacy trial.

What are the potential side effects?

While the side effects aren't specified for CET and EST as they're psychosocial interventions rather than medications, participants may experience discomfort during therapy sessions or when discussing personal issues related to their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of antipsychotic medication for at least 4 weeks.

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My symptoms have not improved over the last 4 weeks.

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I am between 18 and 60 years old.

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My condition is diagnosed as schizophrenia or schizoaffective disorder.

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I have had symptoms for at least 3 months that haven't improved.

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I can read and speak English fluently at a sixth grade level or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a medical condition affecting my thinking or memory.

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I have been diagnosed with organic brain syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Persistent Negative Symptoms

Secondary study objectives

Change in Functioning

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Enhancement TherapyExperimental Treatment1 Intervention

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 II: Enriched Supportive TherapyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Enhancement Therapy

2012

N/A

~160

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,762 Previous Clinical Trials

16,347,913 Total Patients Enrolled

28 Trials studying Schizophrenia

6,348 Patients Enrolled for Schizophrenia

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,446 Total Patients Enrolled

253 Trials studying Schizophrenia

89,834 Patients Enrolled for Schizophrenia

Media Library

Cognitive Enhancement Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04143126 — N/A

Schizophrenia Research Study Groups: Cognitive Enhancement Therapy, Enriched Supportive Therapy

Schizophrenia Clinical Trial 2023: Cognitive Enhancement Therapy Highlights & Side Effects. Trial Name: NCT04143126 — N/A

Cognitive Enhancement Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04143126 — N/A

~12 spots leftby Jun 2025

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