Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY).

BACKGROUND: Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits. Causes of fatigue in schizophrenia are poorly understood and there are no established treatments. Several evidence-based interventions for fatigue syndrome including psychoeducation, cognitive behavioral therapy, and graded exercise therapy have been shown to be effective in other medical conditions and could be adapted to address fatigue in schizophrenia patients. As there are no psychosocial or pharmacological interventions with proved efficacy for fatigue in schizophrenia, there is an urgent need for the development of strategies to improve fatigue management in schizophrenia. The aim of this project is to evaluate in a single blind randomized clinical trial the efficacy of a cognitive-behavioral therapy (CBT) intervention compared to treatment as usual (TAU) on fatigue as the main outcome in schizophrenia patients. Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers are also considered as secondary outcomes. METHODS/DESIGN: Two hundred patients meeting the inclusion criteria will be randomized to either of the study arms (intervention or TAU). The ENERGY intervention will be delivered according to a standardized treatment manual comprising six modules addressing fatigue and sleep over 14 individual therapy sessions. The treatment encompasses core CBT principles of psycho-education, behavioral activation, behavioral experiments, cognitive restructuring, problem-solving, and relapse prevention. Sessions will follow the traditional CBT structure of agenda setting, review of homework tasks, and introduction of a new concept/technique with collaborative discussions on how to implement such strategies in the participant's day-to-day environment. Our primary endpoint will be the severity of fatigue assessed at baseline and at the 9-month follow-up using the "Multidimensional Fatigue Inventory" (MFI). DISCUSSION: The trial will provide the first test of CBT intervention for fatigue for patients with schizophrenia. This study will also test to what extent the treatment can be implemented in everyday practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04332601 . Registered on 10 April 2020.

Why you can't be in sync with schizophrenia patients.

Most individuals with schizophrenia will be confronted with some form of stigma. In recent years, clinicians and family members have increasingly contested the term "schizophrenia". Many of them discuss changing this name, as a means to fight stigma. Up until now, surprisingly, most research has been conducted using self-reports and behavioral research is lacking. The aim of our study was to assess through an experimental design if the term "schizophrenia" itself modifies social behaviours. Forty participants were asked to engage in a synchronization task with a dot displayed on a screen and moved by another person. Non-clinicians participants had to synchronize their movements as accurately as possible with either a "schizophrenia" patient, a patient with "neuro-emotional integration disorder" or a "healthy" subject, kept out of sight. Each condition was counterbalanced between participants. In fact, the movements of the dot were pre-recorded (five trajectories) and were therefore identical for all three conditions. Measuring the error between the displayed and performed trajectories, participants exhibited more errors when they thought they were interacting with a patient in comparison to the "healthy" subject. Post-hoc analysis revealed an even higher difference between "schizophrenia" and "healthy" conditions. Altogether, our results show a significant behavioral impact of the term "schizophrenia" with possibly negative consequences on social interactions. The effect of changing the name reduces this impact but remains unclear.