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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Proximal Humerus Fractures, Neuroticism

In brief

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.

Key facts

Study ID

NCT07415889

Run by

Zaandam Medical Center

People needed

70

Starts

2025-12-02

Expected to finish

2027-12-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Any other fracture besides the proximal humerus fracture in an upper extremity
• Head trauma with neurological symptoms

Where it is running

• Amsterdam University Medical Center — Amsterdam, Netherlands (enrolling)
• Zaandam Medical Center — Zaandam, Netherlands (enrolling)
• OLVG — Amsterdam, Netherlands
• Red Cross Hospital — Beverwijk, Netherlands

Full record on ClinicalTrials.gov

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