Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients
ConditionTuberculosis (TB)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Online Mindfulness
BehavioralThe 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
BehavioralThe 6-week online cbt course developed by our research team consists of 12 video materials, with 2 sessions delivered per week.
Human-computer Interaction
BehavioralThe 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
Behavioralroutine treatment and management services provided by the tuberculosis prevention and control system
Treatment groups
496 Participants
are divided into 4 treatment groupsGroup A: Online Mindfulness Intervention GroupExperimental treatment 1 intervention
Group B: Online CBT Intervention GroupExperimental treatment 1 intervention
Group C: Human-computer Interaction Intervention GroupExperimental treatment 1 intervention
Group D: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-InterventionSecondary outcomes
1
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-Intervention2
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-Intervention3
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-InterventionOther outcomes
1
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-InterventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College
Lead sponsor
Beijing Center for Disease Prevention and Control
Collaborator
Hainan Provincial Center for Disease Control and Prevention
Collaborator
Yichang Center for Disease Control and Prevention, China
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: