Clinical Trial

Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.

Study acronym: ELEVATE
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07415889
Lead Sponsor Zaandam Medical Center
Collaborators: Amsterdam University Medical Center, OLVG, Red Cross Hospital Beverwijk
Conditions Proximal Humerus Fractures, Neuroticism
Enrollment 70 participants
Start Date 2025-12-02
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-17