Status:
COMPLETED
Neurofeedback Training for High Risk Psychosis
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Prodromal Schizophrenia
Eligibility:
All Genders
12-25 years
Phase:
NA
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 ca...
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. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03447548
Start Date
March 1 2018
End Date
December 1 2021
Last Update
February 28 2024
Active Locations (2)
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1
Connecting Adolescents with Psychosis (CAP), Child & Adolescents Day Program
Hartford, Connecticut, United States, 06106
2
Olin Neuropsychiatry Research Center
Hartford, Connecticut, United States, 06106