Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07415889

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here