NCT07415889 Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.
| NCT ID | NCT07415889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zaandam Medical Center |
| Condition | Proximal Humerus Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-12-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Surgically treated proximal humerus fracture, not older than two weeks 2. A high or very high level of neuroticism (cut-off score on NEO-FFI test off 37) 3. Minimal age of 18 years 4. The fracture must be a mono-injury (not part of a multi-injury incident) Exclusion Criteria: 1. Any diagnosed psychiatric disorder that is not adequately managed with medication. 2. Not being able to communicate: language barrier, neurologic disorders 3. Paralysis on the affected arm 4. Not able to participate in online or real time psychological training 5. Any other fracture besides the proximal humerus fracture in an upper extremity 6. Head trauma with neurological symptoms
Contact & Investigator
Robert Jan Derksen, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
Zaandam Medical Center
Frequently Asked Questions
Who can join the NCT07415889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Proximal Humerus Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07415889 currently recruiting?
Yes, NCT07415889 is actively recruiting participants. Contact the research team at d.e.degruijter@amsterdamumc.nl for enrollment information.
Where is the NCT07415889 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amsterdam, Netherlands, Beverwijk, Netherlands, Zaandam, Netherlands.
Who is sponsoring the NCT07415889 clinical trial?
NCT07415889 is sponsored by Zaandam Medical Center. The principal investigator is Robert Jan Derksen, MD, PhD, MSc at Zaandam Medical Center. The trial plans to enroll 70 participants.