Neurofeedback Training for High Risk Psychosis

NCT ID: NCT03447548

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-12-01

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.

Conditions

Prodromal Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Processing speed training

Neurofeedback processing speed training

Group Type: EXPERIMENTAL

Neurofeedback processing speed training

Intervention Type: BEHAVIORAL

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

Active control

Computer games

Group Type: ACTIVE_COMPARATOR

Active control

Intervention Type: BEHAVIORAL

Commercially available games on tablet

Interventions

Neurofeedback processing speed training

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

Intervention Type: BEHAVIORAL

Active control

Commercially available games on tablet

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Hartford, Connecticut, United States

Olin Neuropsychiatry Research Center

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

1R33MH111850-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HHC-2017-0190

Identifier Type: -

Identifier Source: org_study_id