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NOT YET RECRUITING
NCT07703696
NA

Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis

Sponsor: Universitas Diponegoro

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness of Psychosocial Counseling on Treatment Adherence Among Patients With a New Tuberculosis Diagnosis in Primary Care: A Study Protocol of a Quasi-experimental Trial

Key Details

Gender

All

Age Range

17 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-08-19

Completion Date

2026-12-15

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

OTHER

psychosocial counseling

The intervention in this study is a structured psychosocial counseling program developed for newly diagnosed TB patients receiving care in primary health care settings. The counseling is designed to facilitate psychological adjustment following a TB diagnosis, improve understanding of the disease and its treatment, reduce TB-related stigma, strengthen coping strategies, and promote treatment adherence during the intensive phase of anti-tuberculosis treatment. The intervention is delivered individually in a face-to-face format by trained counselors holding at least a bachelor's degree in public health who have received specific training on the counseling protocol and TB patient support. A standardized counseling manual is used to ensure consistency in intervention delivery across all intervention groups. Counseling is provided after the baseline assessment and before initiation of anti-tuberculosis treatment. Each session is conducted in a private counseling room and lasts approximately

Locations (1)

PHC of Kedungmundu, Ngaliyan, Mijen, Gunungpati, Gayamsari, Tlogosari Kulon

Semarang, Central Java, Indonesia