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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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My depression symptoms have been stable for the last 4 weeks.
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I have little to no involuntary movements now and after 4 weeks.
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I have not changed my main antipsychotic medication in the last 3 months.
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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 not currently hospitalized.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Persistent Negative Symptoms
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,716 Previous Clinical Trials
16,346,364 Total Patients Enrolled
25 Trials studying Schizophrenia
6,160 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,775 Previous Clinical Trials
2,673,711 Total Patients Enrolled
247 Trials studying Schizophrenia
89,318 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my demographic meet the criteria for participation in this experiment?

"In order to participate in this study, applicants must be between 18 and 60 years old with a diagnosis of schizophrenia. There are 90 total spots available for suitable candidates."

Answered by AI

What is the highest number of participants that are taking part in this medical study?

"Affirmative, the information on clinicaltrials.gov attests that this examination is currently in search of volunteers. This exploration was originally posted on October 1st 2019 and underwent its most recent revision March 1st 2022. 90 individuals are being accepted at a single location for participation."

Answered by AI

Does this trial extend to people older than 25?

"This clinical trial mandates that patients must be aged between 18 to 60 years old. For those under 18 and over 65, there are 46 and 164 trials respectively for them to participate in."

Answered by AI

Are individuals currently being enrolled for this trial?

"According to clinicaltrials.gov, this research project is actively seeking volunteers and has been since October 1st 2019 (updated on March 1st 2022)."

Answered by AI
~20 spots leftby Jun 2025