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RECRUITING
NCT07415889
NA

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

Sponsor: Zaandam Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-12-02

Completion Date

2027-12

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psychological intervention

Psychological guidance consists of 8 sessions cognitive behavior therapy and starts three weeks after surgery. Sessions consist of psychoeducation and evidence-based interventions and exercises concerning gradual activation relaxation techniques, pain perception and coping with pain, changing unhelpful beliefs, fear, worry about pain and revalidation. Improving treatment adherence (physiotherapy, medication, psychological treatment) and (perceived) social support. Treatment will be guided by licensed medical psychologists. The first 3 sessions will be at the hospital outpatient clinic of the psychologists and the other 5 sessions will be either via videocall or at the outpatient clinic, by patients' choice. The sessions will last 45-60 minutes. There is no use of comparator or placebo.

Locations (4)

Amsterdam University Medical Center

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Red Cross Hospital

Beverwijk, Netherlands

Zaandam Medical Center

Zaandam, Netherlands