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

NCT02459210 | Completed

• 2 other identifiers: 2014P0002851R34MH105596-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Psychosis

Keywords

clinical high risk for psychosis; psychosis prodrome; cognitive remediation; psychosis prevention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Social and Role Functioning at 6 Month and 9 Month (clinical interview)

  Assessed through clinical interview

  Baseline, 6 month, and 9 month

Secondary Outcomes (4)

• Change from Baseline in Neurocognitive functioning (neuropsychological test battery)

  Baseline, 6 month, and 9 month

• Change from Baseline in Social-cognitive functioning (neuropsychological test battery)

  Baseline, 6 month, and 9 month

• Satisfaction with treatment (Self report of client satisfaction)

  6 month and 9 months

• Feasibility of treatment (Rates of attendance for all aspects of treatment)

  6 months and 9 months

Study Arms (2)

CLUES

EXPERIMENTAL

active treatment

Behavioral: CLUES

therapy and computer games

ACTIVE COMPARATOR

supportive therapy + computer games

Behavioral: therapy and computer games

Interventions

CLUES BEHAVIORAL

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

CLUES

therapy and computer games BEHAVIORAL

Weekly psychotherapy+ computer games such as sporcle

therapy and computer games

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (34)

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MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Matcheri Keshavan, MD

  Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley Cobb Professor of Psychiatry

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: June 2, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)