Structured psychological coaching to support recovery after surgically treated shoulder (proximal humerus) fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam University Medical Center
  Amsterdam, Netherlands Recruiting
• Zaandam Medical Center
  Zaandam, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Not yet recruiting
• Red Cross Hospital
  Beverwijk, Netherlands Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.