90 Participants Needed

Cognitive and Activity Therapies for Schizophrenia

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Overseen ByShaun M Eack, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies designed to help individuals with schizophrenia manage persistent negative symptoms, such as difficulty thinking clearly or connecting with others. Cognitive Enhancement Therapy, the first therapy, uses computer programs and group sessions to improve thinking and social skills. The second therapy, Enriched Supportive Therapy, focuses on individual counseling to manage emotions and stress. Individuals with schizophrenia or schizoaffective disorder who have ongoing negative symptoms for at least three months and are on stable medication may be suitable candidates. The trial takes place in Pittsburgh, PA. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance treatment options for schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been stabilized on antipsychotic medication for the evaluation period. This suggests you may need to continue your current antipsychotic medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Cognitive Enhancement Therapy (CET) to be safe for people with schizophrenia. Research shows that CET can improve thinking and social skills. Participants in these studies found the program easy to follow, suggesting it was manageable.

For Enriched Supportive Therapy, the safety information is less clear. However, both treatments are talk-based therapies and do not involve drugs or medical procedures, generally indicating very low risk.

Overall, both treatments appear well-tolerated and aim to help with thinking and emotional skills without significant safety concerns.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to help people with schizophrenia improve their thinking and social skills. Cognitive Enhancement Therapy stands out by combining computer-based cognitive training with social-cognitive group sessions, helping participants understand social situations and perspectives better. This approach specifically targets cognitive deficits, which are often not addressed by standard medications. Meanwhile, Enriched Supportive Therapy focuses on teaching individuals how to manage stress and enhance their social skills through personalized supportive therapy. Both therapies emphasize skill-building and personal insight, which are unique compared to traditional medication-focused treatments.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that Cognitive Enhancement Therapy (CET), one of the treatments in this trial, can improve thinking skills and social interactions in people with early schizophrenia. Studies suggest that CET may reduce disability by enhancing mental abilities, which are crucial for everyday tasks and socializing. Participants in CET often notice improved planning and social skills over time.

Enriched Supportive Therapy (EST) is another treatment option in this trial. It focuses on teaching patients about schizophrenia, managing emotions, and improving social skills. Although specific data on EST alone is limited, studies often compare it with CET. The combination of learning and support in EST may help patients better manage stress and daily challenges. Together, these therapies offer promising benefits for people dealing with ongoing negative symptoms of schizophrenia.36789

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My depression symptoms have been stable for the last 4 weeks.
I have little to no involuntary movements now and after 4 weeks.
I have not changed my main antipsychotic medication in the last 3 months.
See 7 more

Exclusion Criteria

I have a medical condition affecting my thinking or memory.
I have been diagnosed with organic brain syndrome.
You have a history of consistently having thoughts about hurting yourself or others.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Enhancement Therapy or Enriched Supportive Therapy for 18 months

18 months
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Assessments at 21 and 30 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Enhancement Therapy
  • Enriched Supportive Therapy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Enhancement TherapyExperimental Treatment1 Intervention
Group II: Enriched Supportive TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Cognitive enhancement therapy (CET) significantly improved overall cognition in patients with early-course schizophrenia over an 18-month period, as confirmed by a study involving 102 outpatients.
While CET showed promising effects on social cognition and attention, it did not significantly outperform enriched supportive therapy (EST) in improving social adjustment, although the benefits appeared to increase for those who completed the treatment.
Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial.Wojtalik, JA., Mesholam-Gately, RI., Hogarty, SS., et al.[2023]
Cognitive Enhancement Therapy (CET) has been shown to provide lasting benefits in functional outcomes for patients with early course schizophrenia, as evidenced by a follow-up study of 58 patients one year after treatment.
Patients who received CET continued to show significant improvements compared to those who underwent Enriched Supportive Therapy (EST), indicating that cognitive rehabilitation can have a durable impact on managing schizophrenia.
One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia.Eack, SM., Greenwald, DP., Hogarty, SS., et al.[2021]
In a 2-year trial involving 58 early-course schizophrenia patients, cognitive enhancement therapy (CET) led to significant improvements in both neurocognition, particularly executive functioning, and social cognition, specifically emotion management.
These cognitive improvements were found to mediate functional outcomes, suggesting that effective cognitive rehabilitation should address both social and non-social cognitive deficits to enhance overall functioning in individuals with schizophrenia.
Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia.Eack, SM., Pogue-Geile, MF., Greenwald, DP., et al.[2022]

Citations

Confirmatory Efficacy of Cognitive Enhancement Therapy ...CET is effective for improving cognition in early schizophrenia. It appears the functional benefits of CET potentially increase with treatment retention.
Cognitive Enhancement Therapy for Early Course ...CET appears to be an effective approach to the remediation of cognitive deficits in early schizophrenia that may help reduce disability among this population.
Cognitive Enhancement Therapy vs social skills training in ...Confirmatory efficacy of cognitive enhancement therapy for early schizophrenia: results from a multisite randomized trial. Psychiatr Serv ...
Integrative cognitive remediation for early psychosis: A 12- ...The study suggests ICR may have favorable effect on long-term cognitive improvements and functional gains in early psychosis.
Adaptation of Cognitive Enhancement Therapy for Persons ...Research on CET for individuals with schizophrenia has found that CET appears to have helped participants improve cognition and social and work functioning.
Cognitive Enhancement Therapy vs social skills training in ...Confirmatory efficacy of cognitive enhancement therapy for early schizophrenia: results from a multisite randomized trial. Psychiatr Serv ...
A Meta-analysis of Cognitive Remediation for SchizophreniaBroad-spectrum cognitive impairments are a core feature of schizophrenia, present at the first episode of psychosis, and remain stable, or ...
Feasibility of six-month outpatient cognitive remediation in ...Our findings support the feasibility of six-month outpatient CRT in schizophrenia in terms of adherence to scheduled sessions and safety.
Enhanced computerized cognitive remediation therapy ...We hypothesized that patients with schizophrenia receiving CCRT would show significant improvement in psychiatric symptoms and cognitive ...
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