Actively Recruiting
Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.
Led by Zaandam Medical Center · Updated on 2026-02-17
70
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
Z
Zaandam Medical Center
Lead Sponsor
A
Amsterdam University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgically treated proximal humerus fracture not older than two weeks
- High or very high neuroticism score on NEO-FFI test (cut-off 37)
- At least 18 years old
- Fracture is a single injury, not part of a multi-injury event
You will not qualify if you...
- Diagnosed psychiatric disorder not adequately managed with medication
- Unable to communicate due to language barriers or neurological disorders
- Paralysis in the affected arm
- Unable to participate in online or real-time psychological training
- Any other upper extremity fracture besides the proximal humerus fracture
- Head trauma with neurological symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
2
OLVG
Amsterdam, Netherlands
Not Yet Recruiting
3
Red Cross Hospital
Beverwijk, Netherlands
Not Yet Recruiting
4
Zaandam Medical Center
Zaandam, Netherlands
Actively Recruiting
Research Team
D
Denise E de Gruijter, MD
CONTACT
R
Robert Jan Derksen, MD, PhD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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