Psychological sleep and quality of life in patients with inflammatory bowel disease
Conditions
Interventions
Patients in the active phase:None
Remission Patients:None
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, and diagnosed with inflammatory bowel disease (IBD), including ulcerative colitis (UC) or Crohn's disease (CD), in accordance with the "Chinese Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (2023)" to ensure accurate diagnosis and representativeness of the study population; 2. Provision of informed consent and willingness to comply with follow-up visits, thereby ensuring the smooth conduct of the study and the completeness and reliability of the data.
Exclusion criteria
Exclusion criteria: 1. Severe comorbidities or psychiatric history: This includes patients with other diseases that significantly affect quality of life or mental state (such as other intestinal diseases, malignant tumors, etc.), or those with a history of mental illness or currently undergoing treatment for mental illness (such as medication/psychotherapy). This is to reduce the impact of confounding factors on the assessment of psychological symptoms; 2. Communication and cognitive impairments: Patients lacking reading and writing skills or having communication difficulties are excluded to ensure the accuracy and validity of questionnaire completion; 3. Pregnant or lactating women: To avoid potential interference from physiological conditions on psychological and quality of life outcomes, pregnant or lactating women are not included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disease activity: CADI score (CD patients) or Mayo score (UC patients);Change in psychological-somatic symptoms: Change in Hospital Anxiety and Depression Scale (HADS) scores (anxiety/depression subscales);Change in psychological-somatic symptoms: Change in Multidimensional Fatigue Inventory (MFSI) scores;Change in psychological-somatic symptoms: Change in Pittsburgh Sleep Quality Index (PSQI) scores;Change in total score of Inflammatory Bowel Disease Questionnaire (IBDQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| Independent association strength between change in disease activity and change in anxiety symptoms (HADS-A);Independent association strength between change in disease activity and change in depression symptoms (HADS-D);Temporal consistency between fatigue severity (IBD-F) and change in disease activity;Differential impact of change in disease activity on PROMIS-29 domains (physical function, social roles, etc.);Mediating effect of sleep quality in the relationship between disease activity and fatigue;Heterogeneity analysis: Endpoint differences across subgroups by disease severity;Comparison of association patterns across patient groups with different disease subtypes (UC/CD);Moderating effect of inflammatory markers on the relationship between disease activity and psychological symptoms;Inflammatory markers: CRP/FCP; | — |
Countries
China
Contacts
Public ContactMao Jingwei
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed