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

Description

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).

Study Start Date

January 2015

Estimated Completion Date

January 2018

Interventions

  • Behavioral: CLUES
  • Behavioral: therapy and computer games

Specialties

  • Internal Medicine: Psychiatry
  • Nursing: Mental Health
  • Psychiatry: Psychotherapy/analysis,Schizophrenia/Psychosis
  • Physician Assistant: Psychiatry

MeSH Terms

  • Mental Disorders
  • Psychotic Disorders
  • Schizophrenia and Disorders with Psychotic Features

Study ID

Beth Israel Deaconess Medical Center -- 2014P-000285

Status

Unknown

Trial ID

NCT02459210

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

38

Sponsor

Beth Israel Deaconess Medical Center

Inclusion Criteria

    Broad criteria for clinical high risk for psychosis including meeting for SIPS clinical high risk syndrome or any two of the following:
  • Trait risk: Having a first degree relative with a psychotic disorder, or a schizotypal disorder in the patient
  • Positive symptoms: One or more of the attenuated SOPS Positive or Disorganized items scoring mild (3), moderate (4) or severe (5) but not at a psychotic level
  • these may include one or more Basic Symptoms (Klosterkotter et al 2001).
  • Negative symptoms: Two or more of the SOPS negative symptoms rated at least moderate in severity
  • Cognition: executive cognitive impairment (at least 1.0 standard deviation deficit relative to age-expected norms on at least 30% of the measures
  • Functioning: GAF decline > 30% over the last 2 years, sustained for > 1 mo.

Exclusion Criteria

  • History of meeting full criteria for psychotic disorder
  • Significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury)
  • More than 6 months (lifetime) of exposure to antipsychotic treatment
  • A recent (within the past 3 months) history of substance abuse or dependence
  • IQ < 80
  • Failure to achieve at least a 6th grade reading level
  • Persistent suicidal or homicidal behavior

Gender

Both

Ages

16 Years to 25 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center Massachusetts Mental Health Center - Boston, Massachusetts 2.6 miles None None None

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