An interventional study of Personalized Nutrition-Based Psychosomatic Care in Psychosomatic Disorders and Mental Health Care, sponsored by Medical University of Graz. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Health services research
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.
Detailed Description
This is a prospective, monocentric pilot study evaluating the effectiveness of a novel, personalized, nutrition-based outpatient care model for individuals with mental and psychosomatic disorders. The study is conducted at the Department of Medical Psychology, Psychosomatics, and Psychotherapy at the Medical University of Graz, Austria. It is the first clinical research initiative to systematically evaluate outcomes of care at Europe's first outpatient clinic specializing in the relationship between diet and mental health, operating under the framework of Nutritional Psychiatry and Nutritional Psychosomatics.
Background and Rationale Psychiatric and psychosomatic disorders are among the most prevalent and disabling health conditions globally. Conventional treatments-primarily pharmacotherapy and psychotherapy-are often insufficient. Approximately 20-30% of patients remain treatment-resistant despite intensive interventions, suffering from persistent symptoms such as fatigue, pain, sleep disturbances, and cognitive impairments. Additionally, rising incidence rates further highlight the need for innovative, integrative approaches.
Nutritional Psychiatry, a rapidly growing field, examines how dietary patterns and nutritional status impact mood, stress response, and physical symptoms, particularly through mechanisms such as the gut-brain axis. Disruptions in the gut microbiome, linked to poor dietary quality, have been shown to increase systemic inflammation and dysregulate neurotransmitter metabolism, such as serotonin. Research suggests that dietary interventions-especially anti-inflammatory diets rich in omega-3 fatty acids, fiber, and antioxidants (e.g., Mediterranean diet)-can contribute to mental well-being and may play a supportive role in psychosomatic treatment.
The outpatient clinic for Nutrition and Psychosomatics at the LKH Graz offers individualized care incorporating personalized dietary counseling and education, lifestyle guidance, and psychosocial support. The approach is grounded in a salutogenetic model, focusing not only on symptom reduction but also on strengthening health resources and resilience.
Objectives and Hypotheses This pilot study aims to collect preliminary data on the effectiveness of the clinic's integrative care model, focusing on changes in self-reported stress and psychological well-being over a 12-month period. It also seeks to explore potential associations between psychosocial outcomes and physiological parameters such as inflammatory markers.
Primary objective:
To determine whether there is a statistically significant reduction in perceived stress (measured via the Perceived Stress Scale, PSS-10) after one year of care in the outpatient clinic.
Primary hypothesis (H1):
There will be a statistically significant reduction in perceived stress after 12 months of care.
Null hypothesis (H0):
There will be no statistically significant change in perceived stress over the same period.
Secondary objectives include:
Assessing changes in resilience, quality of life, and somatic symptoms.
Evaluating patient satisfaction and subjective health literacy.
Monitoring changes in dietary habits and blood-based biomarkers.
Study Design and Setting This is a non-randomized, single-center, longitudinal, prospective pilot study with repeated measures. Participants will be followed for 12 months, with data collection occurring at baseline and every 3 months thereafter.
Participants are referred by psychiatrists or general practitioners and recruited during their first visit at the clinic. Eligibility screening, informed consent, and baseline assessment occur as part of routine intake procedures. Participation is voluntary, and consent must be provided in writing.
Assessments and Data Collection Self-report instruments will be administered digitally via the EvaSys platform. Participants receive email invitations with secure links to complete the questionnaires online at baseline and every 3 months.
Psychological and health questionnaires include:
Perceived Stress Scale (PSS-10)
Short Form Health Survey (SF-12)
Brief Resilience Scale (BRS-D)
Somatic Symptom Scale (SSS)
EQ-5D-5L
Patient satisfaction questionnaire (adapted from other LKH outpatient services)
NutriMental Screener (baseline only)
Food Frequency Items (baseline and follow-up)
Health literacy is assessed by both patients and their treating physicians using a 10-point Likert scale.
Clinical and demographic variables include: age, sex, BMI, chronic illnesses, psychiatric diagnosis, current medication, smoking status, education, and employment status.
Blood samples are collected as part of routine clinical follow-up at the clinic every 3 months (i.e., not solely for research purposes). Approximately 45 mL of blood will be drawn and analyzed for:
Differential blood count
C-reactive protein (CRP)
Interleukin-6 (IL-6)
Fasting glucose, HOMA-Index
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Liver enzymes (ALT, AST, GGT)
Kidney function (creatinine, urea)
Electrolytes, uric acid
Vitamin D, vitamin B12, ferritin, homocysteine
No experimental treatment or study-specific intervention will be administered.
Sample Size and Statistical Analysis As a pilot study, no formal sample size calculation was performed. Based on clinic records (Jan-Aug 2024: 91 new patients), approximately 10 new patients are expected per month. Assuming a 70% participation rate, the projected sample size is \~84 participants over 12 months.
Quantitative data will be analyzed using IBM SPSS. Descriptive statistics will summarize baseline characteristics. Changes over time will be examined using paired t-tests and repeated-measures ANOVA. Normality assumptions will be assessed using the Shapiro-Wilk or Kolmogorov-Smirnov test.
Correlational analyses (Pearson or Spearman, depending on data distribution) will examine associations between psychological variables and biological markers. Significance is set at p \< 0.05. Qualitative feedback from open-ended survey responses will be analyzed thematically to capture common themes related to patient experience.
Ethical and Legal Considerations This study complies with the Declaration of Helsinki and all relevant national and institutional regulations. Ethics approval has been obtained from the responsible ethics committee. Participation is voluntary, with written informed consent required. Data will be handled confidentially and analyzed in anonymized form only.
Risk-Benefit Assessment Risks are minimal and primarily related to routine blood draws (e.g., mild pain, bruising). Completing online questionnaires may cause fatigue or emotional discomfort; participants may pause or withdraw at any time.
Potential benefits include increased awareness of personal health progress and access to detailed feedback on biopsychosocial factors. Findings will contribute to improved, evidence-based psychosomatic care and support future research on integrative treatment models in Nutritional Psychiatry.
Dissemination of Results Findings from this pilot study will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. Authorship and publication will follow ICMJE guidelines.
Inclusion Criteria:
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
Exclusion Criteria:
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
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
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
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 months
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 months
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 months
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 months
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 months
EQ-5D-5L Index Score
The EQ-5D-5L evaluates five dimensions of health and provides a utility index score. Unit of Measure: Units on a Scale Scale Range: -0.281 (worst health state) to 1 (full health); country-specific Interpretation: Higher scores indicate better health-related quality of life (better outcome)
Time frame: Baseline, 3 months, 6 months, 12 months
REAP-S v.2 Score (Rapid Eating Assessment - Short Version)
The REAP-S v.2 is a brief dietary screener evaluating nutrition quality and eating patterns. Unit of Measure: Units on a Scale Scale: higher = healthier Interpretation: Higher scores generally reflect healthier dietary habits
Time frame: Baseline, 3 months, 6 months, 12 months
OPD Score (Operationalized Psychodynamic Diagnostics)
The OPD instrument assesses psychodynamic functioning including interpersonal relations and internal conflicts. Unit of Measure: Units on a Scale Scale Range: Varies depending on subdomain (specify if available) Interpretation: Interpretation depends on axis; typically, higher dysfunction scores indicate worse outcome
Time frame: Baseline, 6 months, 12 months
Subjective Health Literacy
ubjective health literacy is assessed by both participants and physicians using a 1-10 Likert scale at each time point.
Time frame: Baseline, 3 months, 6 months, 12 months
Body Mass Index (BMI) [kg/m²]
BMI will be calculated from measured height (in meters) and weight (in kilograms). Unit of Measure: kg/m² Scale Range: Typically 10-50 kg/m² Interpretation: Higher BMI indicates greater body mass; classified by WHO as underweight, normal, overweight, obese
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Weight
Body weight measured using a calibrated scale. Unit of Measure: kilograms Interpretation: Used to calculate BMI and assess weight changes
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Height
Height measured using a stadiometer. Unit of Measure: meters Scale Range: 1.3-2.2 m Interpretation: Used to calculate BMI
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Differential Blood Count
Complete blood count with differentiation (e.g., neutrophils, lymphocytes, eosinophils, monocytes, basophils). Unit of Measure: cells/µL or % Scale Range: Depends on cell type Interpretation: Reflects immune status and inflammation
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
C-Reactive Protein (CRP)
CRP is a marker of systemic inflammation. Unit of Measure: mg/L Scale Range: \<5 mg/L = normal Interpretation: Higher levels indicate acute or chronic inflammation
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Interleukin-6 (IL-6)
IL-6 is a pro-inflammatory cytokine. Unit of Measure: pg/mL Scale Range: \<7 pg/mL normal (lab-specific) Interpretation: Elevated in systemic inflammation, infection, stress
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Fasting Blood Glucose
Measured after ≥8 hours of fasting. Unit of Measure: mg/dL Scale Range: 70-100 mg/dL Interpretation: Higher = impaired glucose metabolism or diabetes
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
HOMA-Index
Homeostatic Model Assessment Index calculated from fasting glucose and insulin. Unit of Measure: Unitless Scale Range: \~0.5-2.5 normal Interpretation: Higher values suggest insulin resistance
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Total Cholesterol
Sum of HDL, LDL, and VLDL. Unit of Measure: mg/dL Scale Range: \<200 mg/dL desirable Interpretation: Higher levels associated with cardiovascular risk
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
HDL Cholesterol
High-density lipoprotein cholesterol - "good" cholesterol. Unit of Measure: mg/dL Scale Range: \>40 (men), \>50 (women) Interpretation: Higher values protective
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
LDL Cholesterol
Low-density lipoprotein - "bad" cholesterol. Unit of Measure: mg/dL Scale Range: \<130 mg/dL desirable Interpretation: Higher values increase atherogenic risk
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Triglycerides
Blood lipids, reflecting energy metabolism. Unit of Measure: mg/dL Scale Range: \<150 mg/dL Interpretation: Higher = metabolic risk
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Vitamin D (25-OH)
Storage form of vitamin D Unit of Measure: ng/mL Scale Range: 20-50 optimal Interpretation: Low = deficiency; high = risk of toxicity
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Ferritin
Iron storage protein; also acute-phase reactant. Unit of Measure: ng/mL Scale Range: 20-300 ng/mL Interpretation: Low = iron deficiency, high = inflammation
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Homocysteine
Amino acid linked to B-vitamin status and cardiovascular risk. Unit of Measure: µmol/L Scale Range: \<15 µmol/L Interpretation: Elevated = B12/B6/folate deficiency or oxidative stress
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Vitamin B12
Water-soluble vitamin important for nerve and red blood cell function. Unit of Measure: pg/mL Scale Range: 200-900 pg/mL Interpretation: Low = deficiency with neuro/cognitive risks
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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