← Back to Search

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

No Placebo-Only Group

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

Select...

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

Select...

My symptoms have not improved over the last 4 weeks.

Select...

I am between 18 and 60 years old.

Select...

My condition is diagnosed as schizophrenia or schizoaffective disorder.

Select...

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

Select...

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:

Select...

I have a medical condition affecting my thinking or memory.

Select...

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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