Schizophrenia > Cognitive Enhancement Therapy

Cognitive and Activity Therapies for Schizophrenia

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Must be taking: Antipsychotics

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in 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.

What data supports the effectiveness of the treatment Cognitive Enhancement Therapy for schizophrenia?

Research shows that Cognitive Enhancement Therapy (CET) can improve thinking skills and social functioning in people with early schizophrenia. Studies found that CET helps reduce negative symptoms like social withdrawal and emotional flatness, and these benefits can last even a year after treatment ends.

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Is Cognitive Enhancement Therapy safe for humans?

The research on Cognitive Enhancement Therapy (CET) for schizophrenia does not report any safety concerns, suggesting it is generally safe for humans.

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How is Cognitive Enhancement Therapy (CET) different from other treatments for schizophrenia?

Cognitive Enhancement Therapy (CET) is unique because it combines supportive therapy with social skills and cognitive training to improve thinking and social abilities in people with schizophrenia. Unlike other treatments, CET focuses on enhancing cognitive and social functions through interactive exercises and a supportive therapeutic relationship, which can help reduce negative symptoms like social withdrawal and emotional flatness.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Pittsburgh, PA

Who Is Running the Clinical Trial?

University of Pittsburgh Lead Sponsor

National Institute of Mental Health (NIMH) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy for early-course schizophrenia: effects of a two-year randomized controlled trial. [2022] The early application of cognitive rehabilitation may afford long-term functional benefits to patients with schizophrenia. This study examined the two-year effects of an integrated neurocognitive and social-cognitive rehabilitation program, cognitive enhancement therapy (CET), on cognitive and functional outcomes in early-course schizophrenia.

2. Netherlands pubmed.ncbi.nlm.nih.gov

One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. [2021] Cognitive rehabilitation is an effective intervention for addressing cognitive impairments in patients with schizophrenia. Previous research has shown that the early application of Cognitive Enhancement Therapy (CET) can improve neurocognitive and social-cognitive deficits in the early course of the disorder, and ultimately reduce the substantial functional disability that these patients experience. However, the lasting effects of CET on functional outcome in early course schizophrenia patients remain unknown. In this study, 58 patients in the early course of schizophrenia or schizoaffective disorder treated with 2 years of either CET or an Enriched Supportive Therapy (EST) control were followed-up 1 year after the completion of treatment to examine the durability of CET effects on functional outcome. At one-year post-treatment, a high (72%) retention rate was observed in both treatments. Results from intent-to-treat analyses employing linear mixed-effects models indicated that CET effects on functional outcome were broadly maintained one-year post-treatment, and that patients receiving CET continued to demonstrate highly significant differential functional benefits compared to patients treated with EST. These findings support the durability of CET effects on functional outcome in the early course of schizophrenia, and point to the potential of cognitive rehabilitation to have a lasting impact on the early trajectory of the disorder.

3. United States pubmed.ncbi.nlm.nih.gov

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. [2023] Cognitive enhancement therapy (CET) is an 18-month comprehensive cognitive remediation intervention designed to improve cognition and functioning among patients with schizophrenia. The current study sought to confirm previously observed benefits of CET on cognitive and behavioral outcomes in the early course of the condition in a large multisite trial.

4. Ireland pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. [2021] Cognitive rehabilitation has shown beneficial effects on cognition in patients with schizophrenia, which may also help to improve negative symptoms due to overlapping pathophysiology between these two domains. To better understand the possible relationship between these areas, we conducted an exploratory analysis of the effects of Cognitive Enhancement Therapy (CET) on negative symptoms. Early course schizophrenia outpatients (n=58) were randomized to 2 years of CET or an Enriched Supportive Therapy (EST) control condition. Results revealed significant and medium-sized (d=0.61) differential improvements favoring CET in overall negative symptoms, particularly social withdrawal, affective flattening, and motor retardation. Neurocognitive improvement was associated with reduced negative symptoms in CET, but not EST patients. No relationships were observed between improvements in emotion processing aspects of social cognition, as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test, and negative symptoms. CET represents an effective cognitive rehabilitation intervention for schizophrenia that may also have benefits to negative symptoms. Future studies specifically designed to examine negative symptoms during the course of cognitive rehabilitation are needed.

5. England pubmed.ncbi.nlm.nih.gov

Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. [2022] Cognitive rehabilitation has emerged as an effective treatment for addressing cognitive impairments and functional disability in schizophrenia; however, the degree to which changes in various social and non-social cognitive processes translate into improved functioning during treatment remains unclear. This research sought to identify the neurocognitive and social-cognitive mechanisms of functional improvement during a 2-year trial of cognitive enhancement therapy (CET) for early-course schizophrenia.

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. [2019] Cognitive enhancement therapy (CET) for first-episode schizophrenia combines supportive therapy with social skills and cognitive remediation training. It includes exercises aimed at ameliorating cognitive and negative symptoms in a purposefully motivational format. In this treatment model, the clinician takes an active role as coach, teacher, and therapist in order to engage patients in skills-enhancing work matched to levels of illness and abilities. The therapeutic alliance allows for a safe environment to utilize principles of errorless learning and positive reinforcement. Although this strategy is best implemented in groups, it can be adapted to the individual mode of treatment. Skills-building exercises are described in sufficient detail to be useful to clinicians working with patients in the first years of schizophrenia.

7. United States pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. [2019] Cognitive Enhancement Therapy (CET) is a developmental approach to the rehabilitation of schizophrenia patients that attempts to facilitate an abstracting and "gistful" social cognition as a compensatory alternative to the more demanding and controlled cognitive strategies that often characterize schizophrenia as well as much of its treatment. Selected cognitive processes that developmentally underlie the capacity to acquire adult social cognition have been operationalized in the form of relevant interactive software and social group exercises. Treatment methods address the impairments, disabilities, and social handicaps associated with cognitive styles that appear to underlie the positive, negative, and disorganized symptom domains of schizophrenia. Style-related failures in secondary rather than primary socialization, particularly social cognitive deficits in context appraisal and perspective taking, are targeted goals. Illustrative examples of the techniques used to address social and nonsocial cognitive deficits are provided, together with encouraging preliminary observations regarding the efficacy of CET.