Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
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|ClinicalTrials.gov Identifier: NCT04143126|
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : October 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive Enhancement Therapy Behavioral: Enriched Supportive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This proposed study consists of an 18-month randomized-controlled trial in which 90 outpatients with schizophrenia with moderate-to-severe persistent negative symptoms will be randomized to Cognitive Enhancement Therapy (CET) or Enriched Supportive Therapy (EST) and treated for 18 months. Comprehensive measures of cognition, negative symptoms, and functional outcome will be collected prior to treatment, every 6-months thereafter (6 and 12 months), at treatment completion (18 months), and 3-month post-treatment follow-up (21 months) to provide a rigorous confirmatory test of the efficacy of CET and EST for patients with persistent negative symptoms and the cognitive mechanisms of negative symptom improvement in the disorder.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||March 30, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Cognitive Enhancement Therapy
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
Behavioral: Cognitive Enhancement Therapy
An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.
Other Name: CET
Active Comparator: Enriched Supportive Therapy
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
Behavioral: Enriched Supportive Therapy
An 18-month intervention that 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.
Other Name: EST
- Change in Persistent Negative Symptoms [ Time Frame: Prior to treatment, 6 months, 12, months, 18 months, and 21 months ]Negative symptoms will be assessed using the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a structured interview measure of expressive and motivational negative symptoms consisting of 13 items based on a standardized interview with anchor points for each rating. This measure was developed to address the limitations of previous negative symptom measures and designed for use in clinical trials of negative symptom therapeutics. This outcome has two endpoints that will be evaluated in this trial, persistent negative symptoms related to expression (Expression subscale) and persistent negative symptoms related to motivation/pleasure (Motivation/Pleasure subscale). Items are rated on a 0 to 4 scale, with higher scores indicating greater negative symptom severity.
- Change in Functioning [ Time Frame: Prior to treatment, 6 months, 12, months, 18 months, and 21 months ]A composite index of functional outcomes will be derived from measures of social adjustment commonly used in schizophrenia research. These are clinical interview-based measures of functioning, with some self-report measures, covering vocational, social, family, and other functional outcome domains. Measures will include the Social Adjustment Scale-II, Major Role Adjustment Inventory, the Global Assessment of Functioning, and other field standards of functional outcome in schizophrenia. Because these measures do not share a common Unit of Measure and because of the large number of functional outcome measures used, a composite index will be formed to assess changes in functioning to reduce Type I error from multiple inference testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143126
|Contact: Shaun M Eack, PhDemail@example.com|
|Contact: Michelle M Perrin, MBAfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Shaun Eack, PhD email@example.com|
|Principal Investigator: Shaun Eack, PhD|