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

NCT07415889 | Recruiting DMC

• 1 other identifier: ELEVATE study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Proximal Humerus Fractures; Neuroticism

Keywords

Neuroticism; Proximal humerus fracture; Shoulder; Cognitive behavioral therapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Functional outcome score - Constant Shoulder Score

  The Constant Shoulder Score (CSS) is a comprehensive questionnaire that evaluates shoulder function across four domains: pain, activities of daily living (ADLs), range of motion (ROM), and strength. Pain and ADLs are self-reported by the patient, while ROM and strength are assessed by an investigator. Strength is measured at a 90-degree lateral abduction angle. The CSS consists of 10 items, with a separate assessment for each arm, providing a detailed measure of shoulder function. Lowest score is 0 and highest score is 100. A higher score indicates a better function.

  The score will be tested at 3, 6 and 12 months after surgery.

Secondary Outcomes (9)

• Functional outcome core - Oxford Shoulder Score

  The score will be tested at 3, 6 and 12 months after surgery.

• Functional outcome score - quick Disability of the Arm, Shoulder and Hand

  The score will be tested at 3, 6 and 12 months after surgery.

• Pain levels using Visual Analogue Scale

  The score will be tested at 3, 6 and 12 months after surgery.

• Complications after surgery

  The outcome will be tested at 3, 6 and 12 months after surgery.

• Range of motion

  The outcome will be tested at 3, 6 and 12 months after surgery

Study Arms (2)

Control arm

NO INTERVENTION

Standard care is administered to these participants. Standard care consisting of a surgical treatment of the proximal humerus fracture, painkillers, multiple outpatient clinic visits during recovery and a referral to an physical therapist.

Psychological intervention arm

ACTIVE COMPARATOR

Psychological guidance consisting of 8 sessions with a licensed psychologist. The participants in this group will also get standard care.

Behavioral: Psychological intervention

Interventions

Psychological intervention BEHAVIORAL

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.

Psychological intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically treated proximal humerus fracture, not older than two weeks
• A high or very high level of neuroticism (cut-off score on NEO-FFI test off 37)
• Minimal age of 18 years
• The fracture must be a mono-injury (not part of a multi-injury incident)

You may not qualify if:

• Any diagnosed psychiatric disorder that is not adequately managed with medication.
• Not being able to communicate: language barrier, neurologic disorders
• Paralysis on the affected arm
• Not able to participate in online or real time psychological training
• Any other fracture besides the proximal humerus fracture in an upper extremity
• Head trauma with neurological symptoms

Sponsors & Collaborators

• Amsterdam University Medical Center: collaborator
• OLVG: collaborator
• Red Cross Hospital Beverwijk: collaborator
• Zaandam Medical Center: lead

Study Sites (4)

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

OLVG

Amsterdam, Netherlands

NOT YET RECRUITING

Red Cross Hospital

Beverwijk, Netherlands

NOT YET RECRUITING

Zaandam Medical Center

Zaandam, Netherlands

RECRUITING

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Jan Derksen, MD, PhD, MSc

  Zaandam Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise E de Gruijter, MD

CONTACT

+3175 650 7474; d.e.degruijter@amsterdamumc.nl

Robert Jan Derksen, MD, PhD, MSc

CONTACT

+3175 650 2911; robertjan.derksen@zmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded. The participants and care givers are due to the nature of the intervention not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator; MD, Phd, MSc

Model Details: This study is a randomized controlled trial (RCT) with two arms, where patients are randomly assigned to either the intervention group or the control group. The intervention group receives the intended treatment, while the control group receives standard care. Patients cannot switch between groups during the study. The patients are not blinded during the study.

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: February 17, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

NL (4)