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Neurofeedback Training for High Risk Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03447548
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : October 29, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Prodromal Schizophrenia Behavioral: Neurofeedback processing speed training Behavioral: Active control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with intervention versus active control
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Neurofeedback Processing Speed Training to Improve Social Functioning in Teenagers and Young Adults at Clinical High Risk for Psychosis
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Processing speed training
Neurofeedback processing speed training
Behavioral: Neurofeedback processing speed training
Processing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm

Active Comparator: Active control
Computer games
Behavioral: Active control
Commercially available games on tablet

Primary Outcome Measures :
  1. Change on the Wechsler Intelligence Scale Processing Speed Index [ Time Frame: Baseline, 1 month, 2 month, 6 month ]
    Change on a paper and pencil test of processing speed

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03447548

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Contact: Jimmy Choi, PsyD 860-545-7128
Contact: Jennifer Callaghan, LMSW

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United States, Connecticut
Connecting Adolescents with Psychosis (CAP), Child & Adolescents Day Program Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jennifer Callaghan, LMSW         
Olin Neuropsychiatry Research Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jimmy Choi, PsyD   
Sub-Investigator: Godfrey Pearlson, MD         
Sub-Investigator: Michael Stevens, PhD         
Sub-Investigator: David Glahn, PhD         
Sponsors and Collaborators
Hartford Hospital
National Institute of Mental Health (NIMH)
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Responsible Party: Hartford Hospital Identifier: NCT03447548    
Other Study ID Numbers: HHC-2017-0190
1R33MH111850-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hartford Hospital:
Cognitive training
Social function
Processing speed
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders