Cognitive and Activity Therapies for Schizophrenia

Overseen By Shaun M Eack, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Antipsychotics

Disqualifiers: Organic brain syndrome, Cognitive impairment, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 18 months

90 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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.

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.

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?

Group I: Cognitive Enhancement Therapy Experimental Treatment 1 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 Therapy Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Cognitive enhancement therapy (CET) significantly improved cognitive and functional outcomes in early-course schizophrenia patients over two years, particularly in social cognition and symptom management, compared to enriched supportive therapy (EST).

After two years, CET showed moderate effects on neurocognitive function and strong improvements in social adjustment and negative symptoms, suggesting that early cognitive rehabilitation can help reduce disability in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy for early-course schizophrenia: effects of a two-year randomized controlled trial. Eack, SM., Greenwald, DP., Hogarty, SS., et al.[2022]

Cognitive enhancement therapy (CET) for first-episode schizophrenia effectively combines supportive therapy with social skills and cognitive training, aiming to improve cognitive and negative symptoms in a motivational format.

The therapy emphasizes a strong therapeutic alliance, allowing clinicians to use techniques like errorless learning and positive reinforcement, making it adaptable for both group and individual treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. Miller, R., Mason, SE.[2019]

Cognitive Enhancement Therapy (CET) significantly improved negative symptoms in early course schizophrenia patients, with a medium effect size (d=0.61), particularly in areas like social withdrawal and affective flattening, compared to the control group.

Neurocognitive improvements during CET were linked to reductions in negative symptoms, suggesting that cognitive rehabilitation can be beneficial not only for cognitive deficits but also for negative symptoms in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. Eack, SM., Mesholam-Gately, RI., Greenwald, DP., et al.[2021]

Cognitive Enhancement Therapy (CET) aims to improve social cognition in schizophrenia patients by using interactive software and group exercises, focusing on abstract thinking and social context understanding.

Preliminary observations suggest that CET effectively addresses cognitive deficits related to social interactions, potentially helping patients manage symptoms of schizophrenia more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. Hogarty, GE., Flesher, S.[2019]

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