Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients

NCT07742683 — Not applicable, Not yet recruiting, 496 participants, Peking Union Medical College

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07742683
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	496 (Estimated)
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
Conditions	Tuberculosis (TB)
Interventions	Online Mindfulness, Online CBT Intervention, Human-computer Interaction, Routine treatment and management services provided by the tuberculosis prevention and control system (Behavioral)
Dates	start 2026-10-01 (estimated), primary completion 2027-09-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-08-03, last updated 2026-08-03

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Online Mindfulness Intervention Group	Experimental	Behavioral: Online Mindfulness	Participants in this group received a 6-week online mindfulness course delivered twice weekly.
Online CBT Intervention Group	Experimental	Behavioral: Online CBT Intervention	Participants in this group received a 6-week online CBT intervention course delivered twice weekly.
Human-computer Interaction Intervention Group	Experimental	Behavioral: Human-computer Interaction	The patients in this group are required to use the human-computer interaction system developed by our research institute for a duration of 6 weeks, with a frequency of no less than 2 use per week and a duration of no less than 20 minutes per use.
Control Group	Active comparator	Behavioral: Routine treatment and management services provided by the tuberculosis prevention and control system	Patients in the control group continued to receive routine treatment and management services provided by the tuberculosis prevention and control system throughout the study period. No additional psychosocial services or digital health services were offered beyond routine psychological support.

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

+Outcome measures

Primary outcomes

Stigma: Tuberculosis-related Stigma Scale (TSS) [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]: 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.
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]: 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.
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]: 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

Intervention adherence and acceptability [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.

+Eligibility

Sex: All, ages: 18 Years to any

1\. Inclusion Criteria

1. Aged 18 years or older.
2. 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).
3. Capable of independently completing questionnaires and scale assessments; accessible for sputum collection, chest radiography, biomarker testing and other examinations.
4. Provided full informed consent for the entire study and signed the written informed consent form.

2\. Exclusion Criteria

1. Presence of severe chronic diseases such as immune system disorders, or severe neurological and psychiatric disorders.
2. No access to electronic devices required for subsequent online intervention.
3. Cognitive impairment or hearing loss that impairs normal communication and prevents cooperation with surveys and intervention procedures.
4. Concurrent participation in other health promotion or clinical intervention studies.