CompletedNot Applicable

Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis

Denmark146 participantsStarted 2014-03

Plain-language summary

Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether: * Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups). * Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-40 yrs. * Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following): * Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year. * Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year. * Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year. * Provided informed consent. Exclusion Criteria: * Past history of a treated or untreated psychotic episode of one week's duration or longer * Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use). * Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome * Currently receiving treatment with metylphenidate. * Rejects providing informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brief Assessment of Cognition in Schizophrenia (BACS)

Timeframe: 6 and 12 months

Trial details

NCT IDNCT02098408

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

View on ClinicalTrials.gov More Patients at Ultra-high Risk of Psychosis trials