Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

University of Pittsburgh

Status: Enrolling

Conditions: Schizophrenia

Treatments: Behavioral: Cognitive Enhancement Therapy; Behavioral: Enriched Supportive Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04143126

STUDY19050382

R01MH118267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This project will conduct a confirmatory efficacy trial to examine the efficacy of Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST) for the treatment of schizophrenia patients with significant and persistent negative symptoms. A total of 90 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of CET or EST. Comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of CET and EST for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of CET and EST effects on negative symptoms and functioning.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and:

1. are between 18-60 years of age;
2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
8. have had changes to their primary antipsychotic medication within the previous 3 months;
9. have current IQ > 80; and
10. are able to read (sixth grade level or higher) and speak fluent English. -

Exclusion criteria

Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include:

1. the presence of organic brain syndrome;
2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
3. persistent suicidal or homicidal behavior;
4. significant clinician-estimated medication non-adherence; and
5. SCID-verified substance use disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Cognitive Enhancement Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Enhancement Therapy

Enriched Supportive Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Enriched Supportive Therapy