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Neurofeedback Training for High Risk Psychosis

Primary Purpose

Prodromal Schizophrenia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neurofeedback processing speed training

Active control

About this trial

This is an interventional treatment trial for Prodromal Schizophrenia focused on measuring Cognitive training, Social function, Processing speed

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Case identification and ascertainment depends on the fulfillment of the Criteria of Prodromal States as evaluated using the Structured Interview for Prodromal Syndromes: (1) attenuated positive symptom state which includes the emergence or worsening over the past year of non-psychotic disturbances in thought content, thought process or perceptual abnormality, (2) brief intermittent positive symptoms, and (3) genetic risk and deterioration.
Processing speed at least 0.5 Standard Deviation below the norm, as indexed by baseline performance on Digit Symbol Coding of 8 or below
Age range 12-25 (this age range also comprises the main period of risk for psychosis)
Written informed consent by patients >18 years old, and written assent by subjects <18 years old, with written informed consent by both parents (unless one is deceased or unavailable). Participants who turn 18 while in the study will be re-consented as adults through written informed consent.

Exclusion Criteria:

Current or past diagnosis of psychotic disorder noted at baseline assessment (schizophrenia, schizophreniform, bipolar, schizoaffective, major depression with psychotic features, substance-induced psychosis, psychosis due to a medical condition.
Neurological, neuroendocrine or major medical disorders: as putative prodromal symptoms could be secondary to these and unrelated to risk for primary psychotic disorders (clinical interview), including seizure disorder and history of significant traumatic brain injury
Intelligence Quotient < 70: as putative prodromal symptoms could be secondary to these and unrelated to risk for primary psychotic disorders
Positive symptoms that occur only in the context of substance abuse or withdrawal (i.e. within one month), so as not to include those at risk for substance-induced psychotic disorder
Lack of fluency in English: subjects must speak English to complete behavioral assessments for which psychometric properties have been established in English, complete cognitive training, and in order to comprehend and comply with protocol requirements.
Substance abuse or dependence (including alcohol and marijuana) in previous six months: for purposes of standardization and interpretation of cognitive data.

Sites / Locations

Connecting Adolescents with Psychosis (CAP), Child & Adolescents Day ProgramRecruiting
Olin Neuropsychiatry Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Processing speed training

Active control

Arm Description

Neurofeedback processing speed training

Computer games

Outcomes

Primary Outcome Measures

Change on the Wechsler Intelligence Scale Processing Speed Index

Change on a paper and pencil test of processing speed

Secondary Outcome Measures

Full Information

NCT ID

NCT03447548

First Posted

January 15, 2018

Last Updated

October 28, 2019

Sponsor

Hartford Hospital

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03447548

Brief Title

Neurofeedback Training for High Risk Psychosis

Official Title

Neurofeedback Processing Speed Training to Improve Social Functioning in Teenagers and Young Adults at Clinical High Risk for Psychosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hartford Hospital

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Young people who are at great risk for developing psychosis have cognitive deficits which are strongly related to functioning in the community. This study looks to target a specific cognitive skill called processing speed to see if improving the ability to process information in a timely manner will improve social function in adolescents and young adults at risk for developing schizophrenia. Half will receive neurofeedback cognitive training targeting processing speed while the other half will receive an active control.

Detailed Description

Processing speed deficits are characteristic of schizophrenia and related to its functional impairment, including in its nascent stages, during a putatively prodromal or clinical high risk period. These cognitive deficits have proven relatively refractory to pharmacologic strategies, though the deficits can be improved with cognitive remediation programs in schizophrenia. The cognitive gains can then generalize to functional improvement, particularly early in the course of illness (i.e. first episode psychosis). Although processing speed deficits are also prevalent in young people identified as at clinical high risk for psychosis (i.e. "psychosis risk syndrome"), and related to their concurrent impaired function and predictive of later psychosis (onset of which occurs in 20-25% of clinical high risk cohorts), little research has focused on how to remediate these deficits in clinical high risk patients. Remediating core cognitive deficits in clinical high risk patients could plausibly address present functional impairment in these young people and moderate illness progression. The investigators propose to conduct a double-blind randomized trial in 105 clinical high risk patients to examine a focal processing speed training program versus an active control in terms of improvement in processing speed and social function, and reduction in prodromal symptom severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prodromal Schizophrenia

Keywords

Cognitive training, Social function, Processing speed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial with intervention versus active control

Masking

ParticipantOutcomes Assessor

Masking Description

Double blind

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Processing speed training

Arm Type

Experimental

Arm Description

Neurofeedback processing speed training

Arm Title

Active control

Arm Type

Active Comparator

Arm Description

Computer games

Intervention Type

Behavioral

Intervention Name(s)

Neurofeedback processing speed training

Intervention Description

Processing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm

Intervention Type

Behavioral

Intervention Name(s)

Active control

Intervention Description

Commercially available games on tablet

Primary Outcome Measure Information:

Title

Change on the Wechsler Intelligence Scale Processing Speed Index

Description

Change on a paper and pencil test of processing speed

Time Frame

Baseline, 1 month, 2 month, 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Case identification and ascertainment depends on the fulfillment of the Criteria of Prodromal States as evaluated using the Structured Interview for Prodromal Syndromes: (1) attenuated positive symptom state which includes the emergence or worsening over the past year of non-psychotic disturbances in thought content, thought process or perceptual abnormality, (2) brief intermittent positive symptoms, and (3) genetic risk and deterioration. Processing speed at least 0.5 Standard Deviation below the norm, as indexed by baseline performance on Digit Symbol Coding of 8 or below Age range 12-25 (this age range also comprises the main period of risk for psychosis) Written informed consent by patients >18 years old, and written assent by subjects <18 years old, with written informed consent by both parents (unless one is deceased or unavailable). Participants who turn 18 while in the study will be re-consented as adults through written informed consent. Exclusion Criteria: Current or past diagnosis of psychotic disorder noted at baseline assessment (schizophrenia, schizophreniform, bipolar, schizoaffective, major depression with psychotic features, substance-induced psychosis, psychosis due to a medical condition. Neurological, neuroendocrine or major medical disorders: as putative prodromal symptoms could be secondary to these and unrelated to risk for primary psychotic disorders (clinical interview), including seizure disorder and history of significant traumatic brain injury Intelligence Quotient < 70: as putative prodromal symptoms could be secondary to these and unrelated to risk for primary psychotic disorders Positive symptoms that occur only in the context of substance abuse or withdrawal (i.e. within one month), so as not to include those at risk for substance-induced psychotic disorder Lack of fluency in English: subjects must speak English to complete behavioral assessments for which psychometric properties have been established in English, complete cognitive training, and in order to comprehend and comply with protocol requirements. Substance abuse or dependence (including alcohol and marijuana) in previous six months: for purposes of standardization and interpretation of cognitive data.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jimmy Choi, PsyD

Phone

860-545-7128

jimmy.choi@hhchealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Callaghan, LMSW

Jennifer.Callaghan@hhchealth.org

Facility Information:

Facility Name

Connecting Adolescents with Psychosis (CAP), Child & Adolescents Day Program

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Callaghan, LMSW

Facility Name

Olin Neuropsychiatry Research Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jimmy Choi, PsyD

jimmy.choi@hhchealth.org

First Name & Middle Initial & Last Name & Degree

Godfrey Pearlson, MD

First Name & Middle Initial & Last Name & Degree

Michael Stevens, PhD

First Name & Middle Initial & Last Name & Degree

David Glahn, PhD

12. IPD Sharing Statement

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Neurofeedback Training for High Risk Psychosis

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