Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-65
SponsorUniversitas Diponegoro
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
psychosocial counseling
Other interventionThe 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
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
2 months after interventionSponsors and contacts
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Source ClinicalTrials.gov
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