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Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

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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

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

Trial contacts and locations

1

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Central trial contact

Michelle M Perrin, MBA; Shaun M Eack, PhD

Data sourced from clinicaltrials.gov

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