ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03447548
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hartford Hospital

January 15, 2018
February 27, 2018
February 27, 2018
March 1, 2018
December 1, 2020   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Neurofeedback Training for High Risk Psychosis
Neurofeedback Processing Speed Training to Improve Social Functioning in Teenagers and Young Adults at Clinical High Risk for Psychosis
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.
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.
Interventional
Not Applicable
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
Prodromal Schizophrenia
  • Behavioral: Neurofeedback processing speed training
    Processing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm
  • Behavioral: Active control
    Commercially available games on tablet
  • Experimental: Processing speed training
    Neurofeedback processing speed training
    Intervention: Behavioral: Neurofeedback processing speed training
  • Active Comparator: Active control
    Computer games
    Intervention: Behavioral: Active control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
Same as current
January 1, 2021
December 1, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 25 Years   (Child, Adult)
No
Contact: Jimmy Choi, PsyD 860-545-7128 jimmy.choi@hhchealth.org
Contact: Jennifer Callaghan, LMSW Jennifer.Callaghan@hhchealth.org
United States
 
 
NCT03447548
HHC-2017-0190
1R33MH111850-01A1 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hartford Hospital
Hartford Hospital
National Institute of Mental Health (NIMH)
Not Provided
Hartford Hospital
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP