Authors
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Universität Freiburg -More
Category
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Primary study
Registry of Trials»German Clinical Trials Register
Year
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2026
INTERVENTION: Group 1: This study is a randomised, three‐arms (VR/2D/CG), single blinded, national multicenter project of the University of Fribourg. The objective of the study is to investigate the relation between gastric motility, interoception and eating disorder symptoms. Quantitative data assessment will be conducted relying on self‐report (questionnaire data) and physiological assessments (ECG, EGG and breathing). Data are collected in the laboratory sessions, four sessions within 2 weeks. • Gastric Biofeedback (VR / 2D: Participants view an immersive nature environment depicting a lake and mountains, designed to provide biofeedback through different visual elements. Participants received direct feedback (filtered raw signal) of their stomach activity, where two transparent spheres filled and drained with water in a rhythmic manner, floating above the lake. The left sphere acted as a pacemaker, maintaining a steady rhythm of 3 cpm (corresponding to the normogastric rhythm), while the right sphere reflected the participant’s own EGG activity in real time. Participants also received dimensional Feedback, in which participants’ percentage of normogastric activity was represented through environmental changes, such as cloud density, water color, and variations in wind and water sounds. Higher normogastria resulted in sunnier weather with clearer skies. Participants are instructed in German, and are guided to use relaxation and controlled breathing to influence their own stomach activity (sphere on the right), aligning it with the pacemaker sphere’s rhythm (sphere on the left). They were encouraged to focus on calm breathing and avoid stressing over perfect synchronization, as progress was indicated by the right spheres’ movement and increasingly pleasant weather conditions CONDITION: Anyone with a mental health diagnosis PRIMARY OUTCOME: The primary outcome of this study is the change in gastric interoception following gastric biofeedback training. Gastric interoception refers to an individual's ability to perceive and interpret gastric signals related to hunger and satiety. Impairments in interoception have been identified as a key factor in disordered eating behaviors, particularly in individuals with eating disorders. Given that interoception plays a crucial role in appetite regulation, this study aims to assess whether targeted biofeedback training can change individuals’ perception of gastric sensations. Gastric interoception will be assessed using questionnaires. In addition to self‐report measures, physiological recordings of gastric activity will be obtained using electrogastrography (EGG) to objectively measure gastric motility and its relationship to subjective satiety perception. The primary outcome will be assessed in all four laboratory sessions. The change in interoception from T1 to T4 will be used to determine the effectiveness of the gastric biofeedback intervention. INCLUSION CRITERIA: Fluent in German SECONDARY OUTCOME: This study also includes secondary outcomes aimed at exploring psychological and behavioral factors that may influence interoception: ; ‐ Eating Behavior: This study examines various aspects of eating behavior, including intuitive eating, emotional and external eating patterns, and symptoms of disordered eating. ; ‐ Psychological Distress: Levels of depression, anxiety, and stress are assessed to explore their relationship with interoceptive accuracy and eating behaviors. ; ‐ Alexithymia: Difficulties in identifying and describing emotions are evaluated to investigate their potential role in interoceptive deficits. ; ‐ Emotion Regulation: Individual differences in adaptive and maladaptive emotion regulation strategies are analyzed to assess their influence on gastric interoception.
Epistemonikos ID: d300520855383ba682b17c75f256ebc7875d11d7
First added on: Aug 08, 2026