Patients at Ultra-high Risk of PsychosisFOCUSNCT02098408
Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis
A study testing Cognitive remediation and Standard treatment in people with Patients at Ultra-high Risk of Psychosis, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patients at Ultra-high Risk of Psychosis
- What is being tested?
- Cognitive remediation and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Feb 2019
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.
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).
- Conditions
- Patients at Ultra-high Risk of Psychosis
- Being tested
- Cognitive remediation, Standard treatment
- Keywords
- Ultra-high risk psychosis, Schizophrenia prodrome, Cognitive remediation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationBehavioural
Also called Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science., Social Cognition and Interaction Training (SCIT)
Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014.
The intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients.
Standard treatmentBehavioural
Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + cognitive remediation | Experimental | The cognitive remediation therapy targets neurocognition as well as social cognition. Receives: Behavioral: Cognitive remediation; Behavioral: Standard treatment |
| Standard treatment | Active comparator | Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Assessment of Cognition in Schizophrenia (BACS)
BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.
Measured: 6 and 12 months
Secondary outcomes (4)
Personal and Social Performance Scale (PSP)
Measured: 6 and 12 months
Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
Measured: 6 and 12 months
Scale for the Assessment of Negative Symptoms (SANS)
Measured: 6 and 12 months
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients at Ultra-high Risk of PsychosisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor
- Investigators
- Merete Nordentoft, Professor, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalLouise B Glenthøj, MsC, Study director, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098408
- Sponsor's protocol ID
- H-6-2013-015
- Acronym
- FOCUS
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2014
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kristensen TD, Ebdrup BH, Hjorthoj C, Mandl RCW, Raghava JM, Jepsen JRM, Fagerlund B, Glenthoj LB, Wenneberg C, Krakauer K, Pantelis C, Glenthoj BY, Nordentoft M. No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis-A Randomized Clinical Trial. Front Psychiatry. 2020 Aug 28;11:873. doi: 10.3389/fpsyt.2020.00873. eCollection 2020.
PubMed 33005161Glenthoj LB, Mariegaard LS, Fagerlund B, Jepsen JRM, Kristensen TD, Wenneberg C, Krakauer K, Medalia A, Roberts DL, Hjorthoj C, Nordentoft M. Cognitive remediation plus standard treatment versus standard treatment alone for individuals at ultra-high risk of developing psychosis: Results of the FOCUS randomised clinical trial. Schizophr Res. 2020 Oct;224:151-158. doi: 10.1016/j.schres.2020.08.016. Epub 2020 Aug 29.
PubMed 32873460Wenneberg C, Nordentoft M, Rostrup E, Glenthoj LB, Bojesen KB, Fagerlund B, Hjorthoj C, Krakauer K, Kristensen TD, Schwartz C, Edden RAE, Broberg BV, Glenthoj BY. Cerebral Glutamate and Gamma-Aminobutyric Acid Levels in Individuals at Ultra-high Risk for Psychosis and the Association With Clinical Symptoms and Cognition. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):569-579. doi: 10.1016/j.bpsc.2019.12.005. Epub 2019 Dec 19.
PubMed 32008981Glenthoj LB, Fagerlund B, Randers L, Hjorthoj CR, Wenneberg C, Krakauer K, Vosgerau A, Gluud C, Medalia A, Roberts DL, Nordentoft M. The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:25. doi: 10.1186/s13063-014-0542-8.
PubMed 25623736
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.
- ClinicalTrials.gov ID
- NCT02098408
- Acronym / sponsor ID
- FOCUS / H-6-2013-015
- Conditions
- Patients at Ultra-high Risk of Psychosis
- Keywords
- Ultra-high risk psychosis, Schizophrenia prodrome, Cognitive remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Mar 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 28 Mar 2014 (estimated)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + cognitive remediation | Experimental | Behavioral: Cognitive remediation, Behavioral: Standard treatmentThe cognitive remediation therapy targets neurocognition as well as social cognition. |
| Standard treatment | Active comparator | Behavioral: Standard treatmentPatients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-40 yrs.
- Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):
- Provided informed consent.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Cognitive remediationAlso: Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science., Social Cognition and Interaction Training (SCIT)Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014. The intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients. | Behavioural | Standard treatment + cognitive remediation |
| Standard treatmentPatients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling. | Behavioural | Standard treatment, Standard treatment + cognitive remediation |
Primary outcome
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: 6 and 12 months
BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.
4 secondary outcomes
Personal and Social Performance Scale (PSP)
Time frame: 6 and 12 months
Brief Psychiatric Rating Scale Expanded Version (BPRS-E)
Time frame: 6 and 12 months
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: 6 and 12 months
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 and 12 months
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 16 Sep 2019.
- Derived from this study: PubMed 33005161Kristensen TD, Ebdrup BH, Hjorthoj C, Mandl RCW, Raghava JM, Jepsen JRM, Fagerlund B, Glenthoj LB, Wenneberg C, Krakauer K, Pantelis C, Glenthoj BY, Nordentoft M. No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis-A Randomized Clinical Trial. Front Psychiatry. 2020 Aug 28;11:873. doi: 10.3389/fpsyt.2020.00873. eCollection 2020.
- Derived from this study: PubMed 32873460Glenthoj LB, Mariegaard LS, Fagerlund B, Jepsen JRM, Kristensen TD, Wenneberg C, Krakauer K, Medalia A, Roberts DL, Hjorthoj C, Nordentoft M. Cognitive remediation plus standard treatment versus standard treatment alone for individuals at ultra-high risk of developing psychosis: Results of the FOCUS randomised clinical trial. Schizophr Res. 2020 Oct;224:151-158. doi: 10.1016/j.schres.2020.08.016. Epub 2020 Aug 29.
- Derived from this study: PubMed 32008981Wenneberg C, Nordentoft M, Rostrup E, Glenthoj LB, Bojesen KB, Fagerlund B, Hjorthoj C, Krakauer K, Kristensen TD, Schwartz C, Edden RAE, Broberg BV, Glenthoj BY. Cerebral Glutamate and Gamma-Aminobutyric Acid Levels in Individuals at Ultra-high Risk for Psychosis and the Association With Clinical Symptoms and Cognition. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):569-579. doi: 10.1016/j.bpsc.2019.12.005. Epub 2019 Dec 19.
- Derived from this study: PubMed 25623736Glenthoj LB, Fagerlund B, Randers L, Hjorthoj CR, Wenneberg C, Krakauer K, Vosgerau A, Gluud C, Medalia A, Roberts DL, Nordentoft M. The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:25. doi: 10.1186/s13063-014-0542-8.
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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.
Merete Nordentoft, Professor principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Louise B Glenthøj, MsC study director
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation and Standard treatment in people with Patients at Ultra-high Risk of Psychosis, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 6 inclusion and 5 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 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Brief Assessment of Cognition in Schizophrenia (BACS) (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098408, which also lists 4 linked publications.
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 16 Sep 2019.