Evaluation of the Specialized Clinic for Nutrition and Mental Health: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Lack of consent or inability to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Personalized Nutrition-Based Psychosomatic Care
Other interventionThis 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.
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: Nutrition-Based Psychosomatic CareExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 monthsSecondary outcomes
1
Change in patient satisfaction
Measured via a self-designed patient satisfaction questionnaire, covering areas such as care quality, communication, and organization
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months2
Brief Resilience Scale (BRS-D) Score
The Brief Resilience Scale (BRS-D) assesses psychological resilience-specifically, the ability to bounce back from stress-through 6 items rated on a 5-point Likert scale. Unit of Measure: Units on a Scale Scale Range: 1 (low resilience) to 5 (high resilience) Interpretation: Higher scores indicate greater resilience (better outcome)
Time frame
Baseline, 3 months, 6 months, 12 months3
Somatic Symptom Scale (SSS-8) Score
The Somatic Symptom Scale-8 measures the burden of physical symptoms using 8 items. Unit of Measure: Units on a Scale Scale Range: 0 (no symptoms) to 32 (very high symptom burden) Interpretation: Higher scores indicate greater physical symptom burden (worse outcome)
Time frame
Baseline, 3 months, 6 months, 12 months4
SF-12 Health Survey Score - Physical and Mental Components
Description: The SF-12 assesses health-related quality of life via physical and mental health domains. Scores are standardized. Unit of Measure: Units on a Scale Scale Range: 0 (poor health) to 100 (excellent health) Interpretation: Higher scores indicate better physical or mental health (better outcome)
Time frame
Baseline, 3 months, 6 months, 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: