Evaluation of the Specialized Clinic for Nutrition and Mental Health: A Pilot Study

NCT07050342 | Not Yet Recruiting

• 1 other identifier: 1300/2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational pilot study is to learn how personalized nutrition-focused care can help people with mental and psychosomatic health problems. This study takes place in Europe's first outpatient clinic that focuses on how diet affects mental well-being. The main questions the study aims to answer are: Does care at this clinic help lower participants' stress levels over one year? Do participants report better mental health, resilience, and quality of life during the study? Are improvements in mental health linked to changes in diet and blood markers like inflammation? Participants will: Fill out online questionnaires every 3 months over one year. These ask about stress, physical symptoms, quality of life, diet, and satisfaction with care. Give small blood samples during their regular clinic visits. These samples will be checked for common health markers such as inflammation. This study will help researchers understand whether nutrition-focused care can support mental and physical health, and whether this approach should be tested in larger future studies.

Conditions

Psychosomatic Disorders; Mental Health Care

Keywords

Nutritional Psychiatry; Psychosomatic Disorders; Stress Reduction; Personalized Nutrition; Mental Health

Outcome Measures

Primary Outcomes (1)

• Change in perceived stress levels measured by the Perceived Stress Scale (PSS-10)

  The Perceived Stress Scale (PSS-10) is a validated 10-item self-report questionnaire that measures the degree to which situations in one's life are appraised as stressful. The scale assesses subjective stress over the past month. Scores range from 0 to 40, with higher scores indicating greater perceived stress. Changes in PSS-10 scores from baseline to 12 months will be analyzed to assess the effect of the nutrition-based care intervention on stress levels.

  Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (24)

• Change in patient satisfaction

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Brief Resilience Scale (BRS-D) Score

  Baseline, 3 months, 6 months, 12 months

• Somatic Symptom Scale (SSS-8) Score

  Baseline, 3 months, 6 months, 12 months

• SF-12 Health Survey Score - Physical and Mental Components

  Baseline, 3 months, 6 months, 12 months

• EQ-5D-5L Index Score

  Baseline, 3 months, 6 months, 12 months

Study Arms (1)

Nutrition-Based Psychosomatic Care

EXPERIMENTAL

Participants receive individualized, nutrition-focused care as part of standard treatment in a psychosomatic outpatient clinic. The study observes changes in stress levels, psychological well-being, quality of life, and relevant blood biomarkers over 12 months. No experimental treatment is administered. Participants complete questionnaires and undergo routine blood tests every 3 months.

Other: Personalized Nutrition-Based Psychosomatic Care

Interventions

Personalized Nutrition-Based Psychosomatic Care OTHER

This intervention involves personalized, nutrition-focused care provided in a specialized outpatient clinic for individuals with psychosomatic and mental health conditions. The care model integrates nutritional counseling, education on gut-brain interactions, and patient-centered support to promote psychological well-being and reduce stress. No experimental drugs or diets are administered. Instead, the intervention focuses on individualized recommendations based on clinical assessments and ongoing routine laboratory markers (e.g., inflammatory markers, vitamin levels). Participants also receive guidance aimed at improving dietary habits and resilience within a biopsychosocial framework. The intervention is part of regular clinical care and not blinded or randomized.

Also known as: Nutritional Psychiatry Intervention

Nutrition-Based Psychosomatic Care

Eligibility Criteria

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

You may qualify if:

• New patient at the outpatient clinic for Nutrition and Psychosomatics
• Age between 18 and 65 years
• Sufficient German language skills
• Provided written informed consent
• Able and willing to complete online questionnaires via email

You may not qualify if:

• Lack of consent or inability to provide informed consent
• Diagnosed dementia (Mini-Mental State Exam \< 20)
• Severe substance dependence (e.g., alcohol, benzodiazepines, opioids)
• Serious physical, neurological, or motor impairments preventing questionnaire completion
• No access to or ability to use email for online forms
• Diagnosis of cancer, severe autoimmune disease, or immunosuppression

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (1)

• Morkl S, Ramirez-Obermayer A, DelFabro B, Lackner S, Holasek S, Traub J, Grossbacher K, Brandstatter A, Wilding M, Wagner-Skacel J. Evaluation of the first nutritional psychiatry and psychosomatics outpatient clinic: Protocol for a prospective study of an individualized biopsychosocial therapy approach. PLoS One. 2026 Jan 5;21(1):e0339862. doi: 10.1371/journal.pone.0339862. eCollection 2026.

  PMID: 41490357 DERIVED

MeSH Terms

Conditions

Psychophysiologic Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Central Study Contacts

Sabrina Leal Garcia, Res. Prof. Priv. Doz. DDr.

CONTACT

004331638531520; sabrina.moerkl@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: July 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

AU (1)