An interventional study of Online Mindfulness and Online CBT Intervention in Tuberculosis (TB), sponsored by Peking Union Medical College. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Peking Union Medical College · Not applicable, Interventional, and Supportive care
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 496 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
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1. Inclusion Criteria
2. Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group received a 6-week online mindfulness course delivered twice weekly.
Behavioral: Online Mindfulness
Participants in this group received a 6-week online CBT intervention course delivered twice weekly.
Behavioral: Online CBT Intervention
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.
Behavioral: Human-computer Interaction
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.
Behavioral: Routine treatment and management services provided by the tuberculosis prevention and control system
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.
The 6-week online cbt course developed by our research team consists of 12 video materials, with 2 sessions delivered per week.
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
Stigma: Tuberculosis-related Stigma Scale (TSS)
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.
Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
Mental Health, such as depression （Patient Health Questionnaire, PHQ-9）and anxiety （Generalized Anxiety Disorder Questionnaire, GAD-7）
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.
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)
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.
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)
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
Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
Intervention adherence and acceptability
The usage rate, usage duration of the digital platform, and findings from qualitative interviews were used to assess participants' acceptability of the intervention.
Time frame: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College