Tuberculosis (TB)NCT07742683
Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients
A study testing Online Mindfulness, Online CBT Intervention and Human-computer Interaction in people with Tuberculosis (TB), run by Peking Union Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- Online Mindfulness, Online CBT Intervention and Human-computer Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
About this study
Official title: The Impact of Digital Psychosocial Interventions on Stigma and Health Outcomes in Tuberculosis 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.
- Conditions
- Tuberculosis (TB)
- Being tested
- Online Mindfulness, Online CBT Intervention, Human-computer Interaction, Routine treatment and management services provided by the tuberculosis prevention and control system
- Keywords
- Tuberculosis, Digital Psychosocial Interventions, Stigma, Online Mindfulness Courses, Cognitive Behavioral Therapy, Human-computer Interaction
- Medical subject headings
- Tuberculosis, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online MindfulnessBehavioural
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 InterventionBehavioural
The 6-week online cbt course developed by our research team consists of 12 video materials, with 2 sessions delivered per week.
Human-computer InteractionBehavioural
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 systemBehavioural
routine treatment and management services provided by the tuberculosis prevention and control system
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness Intervention Group | Experimental | Participants in this group received a 6-week online mindfulness course delivered twice weekly. Receives: Behavioral: Online Mindfulness |
| Online CBT Intervention Group | Experimental | Participants in this group received a 6-week online CBT intervention course delivered twice weekly. Receives: Behavioral: Online CBT Intervention |
| Human-computer Interaction Intervention Group | Experimental | 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. Receives: Behavioral: Human-computer Interaction |
| Control Group | Active comparator | 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. Receives: Behavioral: Routine treatment and management services provided by the tuberculosis prevention and control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Shu Jing, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742683
- Sponsor's protocol ID
- CAMS&PUMC-IEC-2026-013
- Status last verified
- Apr 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No