Prodromal SchizophreniaNCT03447548
Neurofeedback Training for High Risk Psychosis
A study testing Neurofeedback processing speed training in people with Prodromal Schizophrenia, run by Hartford Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- Neurofeedback processing speed training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecting Adolescents with Psychosis (CAP), Child & Adolescents Day Program
Hartford, Connecticut, 06106
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106
About this study
Official title: 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.
Read the 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
- Being tested
- Neurofeedback processing speed training, Active control
- Keywords
- Cognitive training, Social function, Processing speed
- Medical subject headings
- Schizotypal Personality Disorder, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback processing speed trainingBehavioural
Processing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm
Active controlBehavioural
Commercially available games on tablet
| Study group | Role | What they receive |
|---|---|---|
| Processing speed training | Experimental | Neurofeedback processing speed training Receives: Behavioral: Neurofeedback processing speed training |
| Active control | Active comparator | Computer games Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Wechsler Intelligence Scale Processing Speed Index
Change on a paper and pencil test of processing speed
Measured: Baseline, 1 month, 2 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with intervention versus active control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447548
- Sponsor's protocol ID
- HHC-2017-0190
- Other IDs
- 1R33MH111850-01A1
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Processing Speed Training to Improve Social Functioning in Teenagers and Young Adults at Clinical High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT03447548
- Acronym / sponsor ID
- HHC-2017-0190
- Conditions
- Prodromal Schizophrenia
- Keywords
- Cognitive training, Social function, Processing speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with intervention versus active control
| Arm | Type | Receives |
|---|---|---|
| Processing speed training | Experimental | Behavioral: Neurofeedback processing speed trainingNeurofeedback processing speed training |
| Active control | Active comparator | Behavioral: Active controlComputer games |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback processing speed trainingProcessing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm | Behavioural | Processing speed training |
| Active controlCommercially available games on tablet | Behavioural | Active control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback processing speed training in people with Prodromal Schizophrenia, run by Hartford Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Wechsler Intelligence Scale Processing Speed Index (time frame: Baseline, 1 month, 2 month, 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.