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Region Hovedstaden - en del af Københavns Universitetshospital

Measures of stress and the functional outcome of patients at ultra-high risk for psychosis.

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To examine biological stress levels in patients at ultra high risk for psychosis and to improve cognitive function, level of stress and psychosocial function in patients at ultra high risk (UHR) for psychosis.

It has clearly been demonstrated that patients fulfilling UHR criteria have a 30 percent risk of transition to psychotic disorder. Likewise, stress seems to be one of the important major biological systems involved in the transition to psychosis. Therefore, RCTs about stress and treatment in UHR groups should have high priority.

The FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical trial enrolling 126 patients meeting the criteria of being at UHR for psychosis. Patients are recruited from psychiatric in and outpatient facilities in Copenhagen. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment versus standard treatment. The cognitive remediation consists of 20 weekly groups-based and manualised sessions targeting neurocognition and social cognition. Follow-up assessments will be conducted after targeting neurocognition and social cognition. Follow-up assessments will be conducted after six and 12 months.
The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment. Secondary outcomes are social and daily functioning and psychosis-like symptoms, Explorative outcomes are level of subjectively experienced stress measured with Recent Life Events and Perceived Stress, heart rate variability, and cortisol awakening response from saliva samples, melatonin and quality of sleep measured with subjective rating and objectively measured activity (wristband activity tracker).

The stress study of the FOCUS trial is the first study, to have included baseline and outcome data on subjectively experienced stress, heart rate variability, cortisol awakening response, melatonin and quality of sleep.


  • Sundhedsvidenskab - Schizophrenia Spectrum and Other Psychotic Disorders, Behavior and Behavior Mechanisms, Randomized Controlled Clinical Trial, Sleep wake disorders, stress, cortisol, hart rate variability, ultra high-risk

ID: 61927978