In the FOCUS project, we wish to stratify individuals at ultra-high risk of developing psychosis by using multimodal variables comparable to the ones used in the PECANS II study. This allows us to compare pathophysiological abnormalities at different stages of the illness. Since antipsychotic medication will not be indicated in most of these patients, the intervention is nonpharmacological, i.e. cognitive remediation.
Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality of life.
The FOCUS trial is a randomized, parallel group, observer-blinded clinical trial enrolling 126 patients meeting the standardized criteria of being at UHR for psychosis. Patients are randomized to five months of treatment in one of two treatment arms: 1) cognitive remediation plus standard treatment versus 2) standard treatment. The cognitive remediation consists of 20 weekly group-based and manualized sessions targeting neurocognition and social cognition. In addition to the group sessions, the patients will be offered 12 individual sessions aiming at maximizing the transfer of the effects of the cognitive training to the everyday lives of the patients. The primary outcome is the effect on a cognitive composite score, with secondary outcomes on social and daily functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology.
This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. Our trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living and symptomatology as well as long-term outcome in preventing transition to psychosis in UHR patients.
PhD theses based on data from this project:
- Louise Birkedal Glenthøj "Targeting functioning in patients at ultra-high risk for psychosis: Findings from the FOCUS trial: The impact of cognition and clinical symptoms on functioning, and means to alleviate functional impairments in patients at ultra-high risk for psychosis" (expected 2017)
- Christina Wenneberg "Glutamatergic and GABAergic disturbances in individuals at ultra-high risk of psychosis: Implications for clinical and functional outcome" (expected 2018)
- Tina Dam Kristensten "Preventing psychosis: Improving brain networks in Ultra High Risk patiens by means of psychological interventions" (expected 2018)