Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis

NCT07703696 | Not Yet Recruiting

• 1 other identifier: 251-10/UN7.D2/PP/IV/2026
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Pulmonary Tuberculosis; Treatment Adherence; Mental Health

Keywords

tuberculosis; psychosocial counseling; treatment adherence; stigma; psychological distress; primary health care; quasi-experimental study

Outcome Measures

Primary Outcomes (1)

• Treatment adherence

  Treatment adherence will be assessed at the two-month follow-up using treatment records maintained by the primary health care centers and a treatment adherence card completed by participants throughout the intensive treatment phase. Adherence will be defined as the extent to which participants follow the prescribed anti-TB treatment regimen during the first two months of therapy.

  2 months after intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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 30-45 minutes.

Other: psychosocial counseling

Control group

NO INTERVENTION

control group will only received standard services from PHC

Interventions

psychosocial counseling OTHER

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

Intervention group

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

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

Semarang, Central Java, 51000, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Treatment Adherence and Compliance; Psychological Well-Being; Tuberculosis; Social Stigma

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior; Personal Satisfaction; Social Behavior

Central Study Contacts

Zahroh Shaluhiyah, PhD

CONTACT

+62811273356; shaluhiyah.zahroh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)