The Impact of Digital Psychosocial Interventions on Stigma and Health Outcomes in Tuberculosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 496
- Primary Endpoint
- Stigma: Tuberculosis-related Stigma Scale (TSS)
Study Overview
Brief Summary
This study addresses the shortcomings of routine clinical management for tuberculosis (TB) patients by proposing psychosocial interventions targeting stigma, while investigating the current status of stigma, psychological issues, medication adherence, and drug resistance among tuberculosis patients. It analyzes the underlying mechanisms, integrates online mindfulness courses, digital cognitive behavioral therapy (CBT), and human-machine interactive dialogue modules to develop a digital psychosocial intervention platform. Through a randomized controlled trial, the study validates the impact of the platform on stigma and health outcomes among tuberculosis patients in China. Ultimately, the research aims to formulate a scalable digital psychosocial intervention technical solution, providing evidence-based support for optimizing China's comprehensive tuberculosis prevention and control model.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Inclusion Criteria
- •Aged 18 years or older.
- •Patients diagnosed with active pulmonary tuberculosis within the past 1 year via bacteriological tests (smear microscopy or culture) and/or molecular biological assays (e.g., GeneXpert).
- •Capable of independently completing questionnaires and scale assessments; accessible for sputum collection, chest radiography, biomarker testing and other examinations.
- •Provided full informed consent for the entire study and signed the written informed consent form.
Exclusion Criteria
- •Presence of severe chronic diseases such as immune system disorders, or severe neurological and psychiatric disorders.
- •No access to electronic devices required for subsequent online intervention.
- •Cognitive impairment or hearing loss that impairs normal communication and prevents cooperation with surveys and intervention procedures.
- •Concurrent participation in other health promotion or clinical intervention studies.
Outcomes
Primary Outcomes
Stigma: Tuberculosis-related Stigma Scale (TSS)
Time Frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
The tuberculosis-related stigma scale (TSS) was adopted in this study to quantitatively assess the level of tuberculosis-related stigma among participants.The scale consists of 9 items in total with a total score range of 0 to 27 points. Higher scores on the TSS indicate a more severe level of tuberculosis-related stigma.
Secondary Outcomes
- Mental Health, such as depression （Patient Health Questionnaire, PHQ-9）and anxiety （Generalized Anxiety Disorder Questionnaire, GAD-7）(Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention)
- Health outcomes, such as sputum conversion rate and quality of life (EuroQol 5 Dimensions，EQ-5D)(Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention)
- Medication Adherence (8-item Morisky Medication Adherence Scale, MMAS-8)(Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention)
Investigators
Shu Jing
Ph.D. candidate
Peking Union Medical College