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

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

• 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

• 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