NCT02245607

Brief Summary

This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico. Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

5.8 years

First QC Date

September 16, 2014

Last Update Submit

February 3, 2021

Conditions

Clinical High RiskPsychosisProdromalSchizophrenia

Keywords

Psychotic DisordersCognitive TrainingMental DisordersSchizophrenia and Disorders with Psychotic Features

Outcome Measures

Primary Outcomes (1)

  • Neurocognition (Global Cognitive Index z score)

    The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition

    3 and 6 months post-baseline

Secondary Outcomes (1)

  • Functional capacity (UPSA/UPSA-A)

    3 and 6 month post-baseline

Other Outcomes (2)

  • Self-reported functioning (SLoF)

    3 and 6 month post-baseline

  • Clinical symptom severity (SOPS total)

    3 and 6 month post-baseline

Study Arms (2)

Compensatory Cognitive Training

EXPERIMENTAL

Compensatory Cognitive Training

Behavioral: Compensatory Cognitive Training

Recreational Therapy

ACTIVE COMPARATOR

Recreational Therapy

Behavioral: Recreational Therapy

Interventions

Compensatory Cognitive TrainingBEHAVIORAL
Compensatory Cognitive Training
Recreational TherapyBEHAVIORAL
Recreational Therapy

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meet Clinical High Risk criteria
  • Be of Latino descent
  • Speak Spanish as their preferred language

You may not qualify if:

  • Concomitant medical or neurological illness
  • Brain injury with loss of consciousness \> 30 minutes
  • Current substance abuse (excluding nicotine)
  • IQ \< 80
  • High suicidal risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

La Jolla, California, 92093, United States

Location

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Interventions

Recreation Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Kristin Cadenhead, MD

    University of California, San Diego

    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
Professor

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 19, 2014

Study Start

October 1, 2014

Primary Completion

June 30, 2020

Study Completion

February 1, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

US(1)ME(1)