Evaluation Der Spezialambulanz Ernährung Und Psyche: Eine Pilotstudie
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in perceived stress levels measured by the Perceived Stress Scale (PSS-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nutrition-Based Psychosomatic Care
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.
干预措施: Personalized Nutrition-Based Psychosomatic Care (Other)
结局指标
主要结局
Change in perceived stress levels measured by the Perceived Stress Scale (PSS-10)
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
次要结局
- Subjective Health Literacy(Baseline, 3 months, 6 months, 12 months)
- Differential Blood Count(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Vitamin D (25-OH)(Baseline, 3 months, 6 months, 9 months, and 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)
- REAP-S v.2 Score (Rapid Eating Assessment - Short Version)(Baseline, 3 months, 6 months, 12 months)
- OPD Score (Operationalized Psychodynamic Diagnostics)(Baseline, 6 months, 12 months)
- Height(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Fasting Blood Glucose(Baseline, 3 months, 6 months, 9 months, and 12 months)
- HOMA-Index(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Total Cholesterol(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Vitamin B12(Baseline, 3 months, 6 months, 9 months, and 12 months)
- 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)
- Body Mass Index (BMI) [kg/m²](Baseline, 3 months, 6 months, 9 months, and 12 months)
- Weight(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Triglycerides(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Ferritin(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Homocysteine(Baseline, 3 months, 6 months, 9 months, and 12 months)
- C-Reactive Protein (CRP)(Baseline, 3 months, 6 months, 9 months, and 12 months)
- HDL Cholesterol(Baseline, 3 months, 6 months, 9 months, and 12 months)
- LDL Cholesterol(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Interleukin-6 (IL-6)(Baseline, 3 months, 6 months, 9 months, and 12 months)