Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis
Starting soon · Not applicable
Conditions studied: Pulmonary Tuberculosis, Treatment Adherence, Mental Health
In brief
Introduction: Newly diagnosed TB patients frequently experience psychological distress, stigma, and concerns regarding treatment duration, side effects, and social consequences, which may negatively affect adherence. Psychosocial counseling has been proposed as a patient-centered strategy to address these challenges; however, evidence regarding its effectiveness among newly diagnosed TB patients in primary care settings remains limited. This study aims to evaluate the effectiveness of a psychosocial counseling intervention in improving treatment adherence and psychosocial outcomes among newly diagnosed TB patients receiving care in primary health care centers. Methods and Analysis: This study will employ a two-arm quasi-experimental design conducted in 10 primary health care centers (PHCs) in Semarang City, Indonesia. Five PHCs will be allocated to the intervention group and five PHCs to the control group to minimize contamination. A total of 108 newly diagnosed pulmonary TB patients will be recruited. Participants in the intervention group will receive a structured psychosocial counseling program in addition to standard TB care, while participants in the control group will receive standard TB care alone. Data will be collected at baseline (T0), immediately after the intervention (T1), and two months after treatment initiation (T2). The primary outcome is treatment adherence during the intensive phase of treatment. Secondary outcomes include psychological distress, TB-related stigma, TB knowledge, and treatment self-efficacy. Data will be analyzed using descriptive statistics, mixed-design analysis of variance, chi-square tests, and multivariable logistic regression.
Key facts
- Study ID
- NCT07703696
- Run by
- Universitas Diponegoro
- People needed
- 108
- Starts
- 2026-08-19
- Expected to finish
- 2026-12-15
- Last updated by the study team
- 2026-07-14
Who can join
Age: 17 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- be adults aged 18 years and older with a newly confirmed diagnosis of pulmonary tuberculosis who are scheduled to initiate anti-tuberculosis treatment at the participating PHCs
You may not qualify if…
- diagnosed with multidrug-resistant tuberculosis (MDR-TB), have severe cognitive impairment or psychiatric disorders that may affect their ability to participate in counseling sessions and study assessments, or have serious medical conditions requiring hospitalization at the time of recruitment.
Where it is running
- PHC of Kedungmundu, Ngaliyan, Mijen, Gunungpati, Gayamsari, Tlogosari Kulon — Semarang, Central Java, Indonesia
Full record on ClinicalTrials.gov
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