Project Details
Projekt
SOMACROSS.2. A Pilot Randomized Controlled Trial of a Mechanism-Based Psychological Intervention for Fatigue in People with Primary Biliary Cholangitis and Primary Sclerosing Cholangitis (SOMA.LIV.2)
Applicants
Professor Dr. Christoph Schramm; Anne Toussaint, Ph.D.
Subject Area
Public Health, Healthcare Research, Social and Occupational Medicine
Gastroenterology
Personality Psychology, Clinical and Medical Psychology, Methodology
Gastroenterology
Personality Psychology, Clinical and Medical Psychology, Methodology
Term
since 2021
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 445297796
Background: Fatigue is a highly prevalent and debilitating symptom in chronic liver disease, profoundly impairing daily functioning and quality of life. Despite its impact, it remains poorly understood and inadequately addressed, representing a significant unmet need. Effective interventions are limited, highlighting an urgent need for research and mechanism-based treatments. Results of the 1st funding phase: In the first funding phase (SOMA.LIV), we demonstrated high prevalence of fatigue and identified biopsychosocial contributors in people with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). Relevant potentially modifiable mechanisms included negative expectations, avoidance beliefs and behaviour, inflammatory markers, and gut microbiome alterations. Objectives: Building on these findings, SOMA.LIV.2 will pilot a novel, mechanism-based psychological intervention specifically targeting the empirically identified processes of expectations and avoidance behaviour. The study will evaluate the feasibility and acceptability of this intervention, obtain preliminary evidence on fatigue severity and variability, examine associations between fatigue, psychological processes, biomarkers, and microbiota, analyse within-person fatigue dynamics using ecological momentary assessment (EMA) and wearables, and characterise long-term fatigue trajectories and correlates in the SOMA.LIV cohort after four years. Work programme: SOMA.LIV.2 is a two-arm pilot RCT with 60 participants (30 intervention, 30 control) comparing standard care with an eight-session online CBT-informed intervention. The intervention specifically addresses unhelpful illness expectations (SOMA.EXPECT module) and fear-avoidance patterns (SOMA.ENGAGE module). Outcomes will be assessed at baseline, mid-treatment (1 month), post-treatment (3 months), and 6- and 12-month follow-ups. A subsample (n=16) will undergo intensive single-case monitoring with EMA and wearables. Blood and stool samples collected pre- and post-intervention will be analysed for inflammatory markers and microbiota, with metabolomic validation conducted in the existing SOMA.LIV cohort. Qualitative interviews with participants and therapists will evaluate intervention experiences. A 4-year follow-up (n≈350) of the SOMA.LIV cohort will characterise long-term fatigue trajectories and biopsychosocial determinants. Expected impact: By piloting a mechanism-informed intervention and integrating multimodal biopsychosocial assessment, SOMA.LIV.2 will provide critical feasibility data and preliminary efficacy signals. Combined quantitative, qualitative, and biological analyses will clarify pathways of fatigue persistence, refine treatment mechanisms, and guide personalized approaches. As part of SOMACROSS.2, the project contributes to a transdiagnostic prediction model of persistent somatic symptoms, advancing mechanistic knowledge and intervention development across chronic conditions.
DFG Programme
Research Units
