Patients at Ultra-high Risk of Psychosis Clinical Trial
— FOCUSOfficial 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.
| NCT number | NCT02098408 |
| Other study ID # | H-6-2013-015 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | February 2019 |
| Verified date | March 2019 |
| Source | Mental Health Services in the Capital Region, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 146 |
| Est. completion date | February 2019 |
| Est. primary completion date | February 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Mental Health Centre Copenhagen | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Mental Health Services in the Capital Region, Denmark | Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Copenhagen Trial Unit, Center for Clinical Intervention Research |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A) | 6 and 12 months | ||
| Other | Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A) | 6 and 12 months | ||
| Other | Global Functioning: Social and Role Scales | 6 and 12 months | ||
| Other | Quality Of Life Scale (QOLS). | 6 and 12 months | ||
| Other | Comprehensive Assessment of At-Risk Mental States (CAARMS) | 6 and 12 months | ||
| Other | The Awareness of Social Inference Test (TASIT) | 6 and 12 months | ||
| Other | Emotion Recognition Task (ERT) | Emotion Recognition Task from CANTAB | 6 and 12 months | |
| Other | Social Responsiveness Scale (SRS) | 6 and 12 months | ||
| Other | Social Cognition Screening Questionnaire (SCSQ) | 6 and 12 months | ||
| Other | Adverse events | Number of participants with adverse events | 6 and 12 months | |
| Other | The High-Risk Social Challenge (HiSoC) Task | 6 and 12 months | ||
| Primary | 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. | 6 and 12 months | |
| Secondary | Personal and Social Performance Scale (PSP) | 6 and 12 months | ||
| Secondary | Brief Psychiatric Rating Scale Expanded Version (BPRS-E) | 6 and 12 months | ||
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) | 6 and 12 months | ||
| Secondary | The Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 and 12 months |