Structured psychological coaching to support recovery after surgically treated shoulder (proximal humerus) fracture
Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.
This trial tests whether adding structured psychological coaching to usual care helps adults with high neuroticism recover better after surgical repair of a proximal humerus (shoulder) fracture.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zaandam Medical Center Academic / other |
| Locations | 4 sites (Amsterdam and 3 other locations) |
| Trial ID | NCT07415889 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, single-blind trial will enroll adults who had surgical repair of a proximal humerus fracture and score high on neuroticism. Eligible patients are screened with the NEO-FFI and randomized to receive structured psychological coaching plus standard postoperative care or standard care alone. Researchers will track functional outcomes, range of motion, pain, medication use, return to work, and psychological measures such as anxiety, depression, fear of movement, self-efficacy, resilience, and pain cognitions during recovery. Sites include Amsterdam UMC, OLVG, and Red Cross Hospital Beverwijk in the Netherlands, and outcome assessors are blinded to group assignment.
Who should consider this trial
Good fit: Adults (≥18) who underwent surgical treatment for a proximal humerus fracture within two weeks, score high or very high on neuroticism (NEO-FFI ≥37), have a single shoulder injury, can communicate and participate in online or live psychological sessions, and do not have unmanaged psychiatric disorders are ideal candidates.
Not a fit: Patients without elevated neuroticism, those with multi-trauma or other upper-extremity fractures, unmanaged psychiatric disorders, paralysis of the affected arm, inability to participate in online or real-time psychological training, or who had non-surgical fracture management are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding psychological coaching could improve shoulder function, reduce pain and medication use, and speed return to work for mentally vulnerable patients.
How similar studies have performed: Observational studies link higher neuroticism and mental distress to poorer outcomes after shoulder surgery, but randomized trials testing structured psychological coaching in this specific population are limited, so the approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 3 other locations
- 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)
Study contacts
- Principal investigator: Robert Jan Derksen, MD, PhD, MSc — Zaandam Medical Center
- Study coordinator: Denise E de Gruijter, MD
- Email: d.e.degruijter@amsterdamumc.nl
- Phone: +3175 650 7474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.