About this trial
Although physical factors play an important role in the treatment and outcomes after proximal humerus fracture (PHF), psychosocial factors need to be taken into account as well.
Few studies have been done to assess the influence of psychosocial factors and mental distress on the outcomes after shoulder surgery and show that it has a negative correlation on the outcomes. It is reported that having low resilience, negative thoughts, signs of depression or anxiety have a significant negative relation with the patient reported outcomes (PROMs).
Mental vulnerability is linked to neuroticism, a personality factor of the Big Five traits, that can be characterized by the tendency to experience negative affect, especially when threatened, frustrated, or facing loss. Neuroticism is related to worse outcomes of health and disease in patients. Although studies have been done to objectify the correlation between psychological factors and functional outcomes after surgery there has not yet been a trial where an intervention has taken place to improve functional outcomes when patients have neurotic tendencies. With this study, we aim to improve the functional outcomes for patients with neuroticism and proximal humerus fractures undergoing surgery by giving them psychological training in the form of focused cognitive behavioral therapy additionally to the standard care. Psychological treatment has shown to improve the well-being of the 'patient characteristics associated with neuroticism and reduce rumination and worry.
Therefore, we hypothesize that providing psychological guidance, consisting of a focused cognitive behavioral therapy program, to patients with neuroticism after a PHF will lead to better patient related outcomes.
Eligibility criteria
Qualifiers
Surgically treated proximal humerus fracture, not older than two weeks
A high or very high level of neuroticism (cut-off score on NEO-FFI test off 37)
Minimal age of 18 years
The fracture must be a mono-injury (not part of a multi-injury incident)
Disqualifiers
Any diagnosed psychiatric disorder that is not adequately managed with medication.
Not being able to communicate: language barrier, neurologic disorders
Paralysis on the affected arm
Not able to participate in online or real time psychological training
Trial design
Treatments tested in this trial
- Psychological intervention
Treatment groups
Sponsors and collaborators
Zaandam Medical Center
Lead sponsor
Amsterdam University Medical Center
Collaborator
OLVG
Collaborator
Red Cross Hospital Beverwijk
Collaborator