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Study identifier: NCT07415889 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Proximal Humerus Fractures · Neuroticism  ·  Sponsor: Zaandam Medical Center

PhaseNA
Planned participants70
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 a…

This description comes directly from the study's public registry record.

Talk to the study team

Denise E de Gruijter, MD  ·  +3175 650 7474  ·  d.e.degruijter@amsterdamumc.nl

Robert Jan Derksen, MD, PhD, MSc  ·  +3175 650 2911  ·  robertjan.derksen@zmc.nl

Always discuss trial participation with your own doctor first.

Locations (4)

Amsterdam University Medical CenterAmsterdam, NetherlandsRecruiting
OLVGAmsterdam, NetherlandsNot Yet Recruiting
Red Cross HospitalBeverwijk, NetherlandsNot Yet Recruiting
Zaandam Medical CenterZaandam, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT07415889