90 Participants Needed

Cognitive and Activity Therapies for Schizophrenia

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SM
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)

Trial Summary

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.12345

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.12346

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.13467

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.

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.
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

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

Treatment Details

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.
Participant Groups
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

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+

Findings from Research

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.
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) 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]
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]

References

Cognitive enhancement therapy for early-course schizophrenia: effects of a two-year randomized controlled trial. [2022]
One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. [2021]
Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. [2023]
Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. [2021]
Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. [2022]
Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. [2019]
Practice principles of cognitive enhancement therapy for schizophrenia. [2019]
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