Patients at Ultra-high Risk of Psychosis
Conditions
Keywords
Ultra-high risk psychosis, Schizophrenia prodrome, Cognitive remediation
Brief 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).
Interventions
BEHAVIORALCognitive remediation
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.
BEHAVIORALStandard treatment
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.
Sponsors
Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS
Copenhagen Trial Unit, Center for Clinical Intervention Research
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Assessment of Cognition in Schizophrenia (BACS) | 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
| Measure | Time frame |
|---|---|
| Personal and Social Performance Scale (PSP) | 6 and 12 months |
| Brief Psychiatric Rating Scale Expanded Version (BPRS-E) | 6 and 12 months |
| Scale for the Assessment of Negative Symptoms (SANS) | 6 and 12 months |
| The Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 and 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Awareness of Social Inference Test (TASIT) | 6 and 12 months | — |
| Emotion Recognition Task (ERT) | 6 and 12 months | Emotion Recognition Task from CANTAB |
| Social Responsiveness Scale (SRS) | 6 and 12 months | — |
| Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A) | 6 and 12 months | — |
| Adverse events | 6 and 12 months | Number of participants with adverse events |
| The High-Risk Social Challenge (HiSoC) Task | 6 and 12 months | — |
| Social Cognition Screening Questionnaire (SCSQ) | 6 and 12 months | — |
| Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A) | 6 and 12 months | — |
| Global Functioning: Social and Role Scales | 6 and 12 months | — |
| Quality Of Life Scale (QOLS). | 6 and 12 months | — |
| Comprehensive Assessment of At-Risk Mental States (CAARMS) | 6 and 12 months | — |
Countries
Denmark
Outcome results
None listed