Neurofeedback Training for High Risk Psychosis

NCT03447548 | Completed

• 2 other identifiers: HHC-2017-01901R33MH111850-01A1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Prodromal Schizophrenia

Keywords

Cognitive training; Social function; Processing speed

Outcome Measures

Primary Outcomes (1)

• Change on the Wechsler Intelligence Scale Processing Speed Index

  Change on a paper and pencil test of processing speed

  Baseline, 1 month, 2 month, 6 month

Study Arms (2)

Processing speed training

EXPERIMENTAL

Neurofeedback processing speed training

Behavioral: Neurofeedback processing speed training

Active control

ACTIVE COMPARATOR

Computer games

Behavioral: Active control

Interventions

Neurofeedback processing speed training BEHAVIORAL

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

Processing speed training

Active control BEHAVIORAL

Commercially available games on tablet

Active control

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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

Hartford, Connecticut, 06106, United States

Location

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Schizotypal Personality Disorder; Social Adjustment

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with intervention versus active control

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 27, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (2)