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NCT Number: NCT07742683

Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients

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.

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Gram-Positive Bacterial Infections Infections Mycobacterium Infections Social Behavior Social Stigma Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Online Mindfulness

Behavioral

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.

Online CBT Intervention

Behavioral

The 6-week online cbt course developed by our research team consists of 12 video materials, with 2 sessions delivered per week.

Human-computer Interaction

Behavioral

The human-computer interaction mini-program named Xiexin Xiangban, developed by the research team.

Routine treatment and management services provided by the tuberculosis prevention and control system

Behavioral

routine treatment and management services provided by the tuberculosis prevention and control system

Primary outcomes

  1. 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

  1. 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

    Patient Health Questionnaire-9 (PHQ-9) was used to assess the depressive symptoms of the participants in this study. The PHQ-9 is a validated, brief self-reported rating scale consisting of 9 items, which specifically targets the core diagnostic symptoms of depression. Each item is scored on a 4-point Likert scale, and the total score ranges from 0 to 27. Higher total scores indicate more severe depressive symptoms.

    Generalized Anxiety Disorder-7 (GAD-7) was utilized to evaluate the anxiety symptoms of the subjects. All 7 items are rated on a 4-point scoring system, with a total score ranging from 0 to 21. Higher scores represent more serious anxiety symptoms.

  2. 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

    Extract patients' sputum smear and culture results from medical records. EuroQol 5 Dimensions (EQ-5D) was employed to evaluate the health-related quality of life of the participants in the present study. Each dimension of the EQ-5D is rated with a standardized response level, and the corresponding utility value is calculated to generate a final summary index score. The utility score ranges from 0.000 to 1.000, where 1.000 represents perfect health, a score of 0 indicates a state equivalent to death. Higher EQ-5D utility scores indicate better health-related quality of life.

  3. 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

    The 8-item Morisky Medication Adherence Scale (MMAS-8) was used to assess participants' medication adherence. This scale contains 8 items with a total score ranging from 0 to 8. Higher scores correspond to better medication adherence

Other outcomes

  1. Intervention adherence and acceptability

    Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention

    The usage rate, usage duration of the digital platform, and findings from qualitative interviews were used to assess participants' acceptability of the intervention.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Collaborators

  • Beijing Center for Disease Prevention and Control
  • Hainan Provincial Center for Disease Control and Prevention
  • Yichang Center for Disease Control and Prevention, China

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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