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Completed

NCT Number: NCT02098408

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

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).

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Key information

Conditions

Patients at Ultra-high Risk of Psychosis

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Centre Copenhagen

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation

Behavioral

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.

Other names: Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science., Social Cognition and Interaction Training (SCIT)

Standard treatment

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Personal and Social Performance Scale (PSP)

    Time frame: 6 and 12 months

  2. Brief Psychiatric Rating Scale Expanded Version (BPRS-E)

    Time frame: 6 and 12 months

  3. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: 6 and 12 months

  4. The Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 6 and 12 months

Other outcomes

  1. Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A)

    Time frame: 6 and 12 months

  2. Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A)

    Time frame: 6 and 12 months

  3. Global Functioning: Social and Role Scales

    Time frame: 6 and 12 months

  4. Quality Of Life Scale (QOLS).

    Time frame: 6 and 12 months

  5. Comprehensive Assessment of At-Risk Mental States (CAARMS)

    Time frame: 6 and 12 months

  6. The Awareness of Social Inference Test (TASIT)

    Time frame: 6 and 12 months

  7. Emotion Recognition Task (ERT)

    Time frame: 6 and 12 months

    Emotion Recognition Task from CANTAB

  8. Social Responsiveness Scale (SRS)

    Time frame: 6 and 12 months

  9. Social Cognition Screening Questionnaire (SCSQ)

    Time frame: 6 and 12 months

  10. Adverse events

    Time frame: 6 and 12 months

    Number of participants with adverse events

  11. The High-Risk Social Challenge (HiSoC) Task

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS
  • Copenhagen Trial Unit, Center for Clinical Intervention Research

Registry information

Official study 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.

Acronym: FOCUS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2014
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.