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Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis

NCT02459210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-05-07

No results posted yet for this study

Summary

The purpose of this study is to test the feasibility of a modification of CET (Cognitive Enhancement Therapy) to address symptomatic and functional difficulties associated with Clinical High Risk for Psychosis (CHR).

Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to improve school, work, and social functioning. CLUES includes the following:

1. Computerized cognitive remediation ("exercises") to improve cognition.
2. Social-cognitive skills group designed to teach participants to act wisely in social situations.
3. Individual coaching sessions designed to enhance translation of skills learned from computer exercises and the group into real life.

CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was designed for treating individuals with schizophrenia. Research on CET for individuals with schizophrenia has found that CET appears to have helped participants improve cognition and social and work functioning.

This study will investigate the feasibility of CLUES for young people who are showing signs of clinical risk for psychosis.

Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of target engagement (change in cognition and social cognition), to refine assessment and recruitment approaches, to further optimize the treatment manual, and to ascertain feasibility and tolerability.

Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) + computer games to explore preliminary evidence of efficacy of CLUES vs. the control treatment (n=30).

Conditions

Interventions

BEHAVIORAL

CLUES

Cognition for learning and for understanding everyday social situations intervention described above

BEHAVIORAL

therapy and computer games

Weekly psychotherapy+ computer games such as sporcle

Sponsors & Collaborators

Principal Investigators

  • Matcheri Keshavan, MD · Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459210 on ClinicalTrials.gov