The urgent requirement for robust evidence addressing the mental health comorbidity associated with tuberculosis (TB) is particularly pressing in lower-middle-income countries. This study delves into the effectiveness and cost-efficiency of cognitive behavioural therapy (CBT) compared to enhanced treatment as usual (ETAU) in alleviating depressive symptoms and promoting adherence to anti-TB treatment (ATT) among TB patients with comorbid depression in Pakistan.
The research employs a pragmatic parallel arm randomized control trial with an internal pilot. A specialized brief psychological intervention based on CBT has been crafted through qualitative and ethnographic studies. The pilot phase will involve 80 participants, while the definitive trial aims to recruit 560 participants, split evenly between the two groups. Patients who commence ATT within a month of being diagnosed with pulmonary, extrapulmonary TB, or multidrug-resistant TB (MDR-TB) and who meet the depression criteria on the Patient Health Questionnaire-9 (PHQ-9) will be randomized to receive either six sessions of CBT or ETAU.
Study Methods and Design
Participants will be randomly assigned in a 1:1 ratio to either the CBT or ETAU group. The primary outcomes to be assessed include the severity of depression using the PHQ-9 scale and adherence to ATT. These outcomes will be measured at baseline, and at 8, 24, and 32 weeks post-randomization for depression severity and at baseline and week 24 for ATT adherence. A blinded assessor will ensure unbiased evaluation of the results.
The internal pilot will help gauge the feasibility of the intervention, and its outcomes will determine whether the definitive trial proceeds. The intervention will be delivered by trained TB healthcare workers, ensuring its applicability in real-world settings.
Ethical Considerations and Dissemination
The study has received ethical clearance from multiple committees, including Keele University Research Ethics Committee, Khyber Medical University Ethical Review Board, and the National Bioethics Committee of Pakistan. The findings will be published in peer-reviewed journals and presented at academic conferences. Results will also be shared with stakeholders and policymakers to inform future TB treatment strategies.
Practical Implications for Healthcare Providers
– Integrating CBT sessions into TB treatment protocols can substantially improve mental health outcomes for patients.
– Training TB healthcare workers in delivering CBT ensures scalability and real-world applicability.
– Monitoring the cost-effectiveness of CBT will provide valuable insights for resource allocation in lower-middle-income countries.
– Adopting a randomized control trial framework helps in establishing robust evidence for mental health interventions.
The results of this trial are anticipated to offer significant insights into the dual management of TB and depression, potentially transforming treatment paradigms in similar socio-economic contexts.
Original Article: BMJ Open. 2024 Jun 17;14(6):e083483. doi: 10.1136/bmjopen-2023-083483.
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