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Not yet recruiting NCT07742683

Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients

No phase Interventional Tuberculosis (TB)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Online Mindfulness, Online CBT Intervention, Human-computer Interaction, Routine treatment and management services provided by the tuberculosis prevention and control system.
Who it may be relevant to
Registry conditions: Tuberculosis (TB). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Digital Psychosocial Interventions on Stigma and Health Outcomes in Tuberculosis Patients

Overview

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.

Interventions

  • Behavioral Online Mindfulness
    The 6-week online mindfulness course developed by our research team consists of theoretical lectures plus practice audio and video materials, with 2 sessions delivered per week.
  • Behavioral Online CBT Intervention
    The 6-week online cbt course developed by our research team consists of 12 video materials, with 2 sessions delivered per week.
  • Behavioral Human-computer Interaction
    The human-computer interaction mini-program named Xiexin Xiangban, developed by the research team.
  • Behavioral Routine treatment and management services provided by the tuberculosis prevention and control system
    routine treatment and management services provided by the tuberculosis prevention and control system

Primary outcome measures

  • Stigma: Tuberculosis-related Stigma Scale (TSS) [Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention]
Secondary outcome measures (3)
  • Mental Health, such as depression （Patient Health Questionnaire, PHQ-9）and anxiety （Generalized Anxiety Disorder Questionnaire, GAD-7） [Time frame: 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) [Time frame: 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) [Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention]

Eligibility 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.

2\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742683 · CAMS&PUMC-IEC-2026-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗