Helpful explanatory models for somatoform symptoms (HERMES): study protocol of a randomised mixed-methods pilot trial

Area of Science:

• Psychosomatic Medicine
• Clinical Psychology
• Primary Care Research

Background:

• Persistent somatic symptoms (PSS) present a significant challenge in healthcare, causing considerable psychological and somatic burden.
• Healthcare providers often face communication difficulties due to a lack of scientifically supported explanatory models for PSS.
• Existing approaches may overly focus on somatic aspects, failing to meet patients' comprehensive needs.

Purpose of the Study:

• To develop a psychoeducational intervention for PSS grounded in an evidence-based explanatory model.
• To assess the feasibility of this intervention in a clinical setting.
• To lay the groundwork for a large-scale randomized controlled trial.

Main Methods:

• A randomized controlled mixed-methods pilot trial involving 75 adult psychosomatic outpatients with PSS.
• Three groups: explanatory model only, personalized explanatory model, and PSS guidelines information (control).
• Interventions delivered via tablet; outcomes assessed through quantitative measures and qualitative interviews.

Main Results:

• The study is designed to compare changes in psychological and somatic symptom burden across the three groups.
• It will evaluate behavioral change mechanisms and the feasibility of each intervention.
• Primary outcomes will be quantitatively compared after one month.

Conclusions:

• The findings will provide insights into the effectiveness and feasibility of a novel psychoeducational intervention for PSS.
• This research aims to improve communication and patient care for individuals experiencing persistent somatic symptoms.
• Results will inform the design of future, larger-scale randomized controlled trials in psychosomatic medicine.