Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis

NCT07703696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Universitas Diponegoro

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-19
Primary Completion
2026-11-30
Completion
2026-12-15

Countries

  • Indonesia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703696 on ClinicalTrials.gov