Digital Psychosocial Interventions on Stigma and Health Outcomes in TB Patients | NCT07742683

NCT07742683

Overview

NCT ID: NCT07742683
Lead Sponsor: Peking Union Medical CollegeOTHER
Official Title: The Impact of Digital Psychosocial Interventions on Stigma and Health Outcomes in Tuberculosis Patients
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Oct 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 1. 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.

2. 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 496Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Online Mindfulness Intervention GroupExperimental

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

Behavioral: Online Mindfulness

Online CBT Intervention GroupExperimental

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

Behavioral: Online CBT Intervention

Human-computer Interaction Intervention GroupExperimental

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 GroupActive 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