Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients

NCT07742683 | Not Yet Recruiting

• 1 other identifier: CAMS&PUMC-IEC-2026-013
• Study Type: interventional
• Target: 496
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tuberculosis (TB)

Keywords

Tuberculosis; Digital Psychosocial Interventions; Stigma; Online Mindfulness Courses; Cognitive Behavioral Therapy; Human-computer Interaction

Outcome Measures

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.

  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）

  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)

  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)

  Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention

Other Outcomes (1)

• Intervention adherence and acceptability

  Baseline, Post-Intervention, 3-month Post-Intervention, 6-month Post-Intervention, 1-year Post-Intervention

Study Arms (4)

Online Mindfulness Intervention Group

EXPERIMENTAL

Participants in this group received a 6-week online mindfulness course delivered twice weekly.

Behavioral: Online Mindfulness

Online CBT Intervention Group

EXPERIMENTAL

Participants in this group received a 6-week online CBT intervention course delivered twice weekly.

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.

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.

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

Interventions

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 Mindfulness Intervention Group

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.

Online CBT Intervention Group

Human-computer Interaction BEHAVIORAL

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

Human-computer Interaction Intervention Group

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead
• 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

MeSH Terms

Conditions

Tuberculosis; Social Stigma

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. candidate

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-04