Authors
Nishani Fonseka, Zohaib Khan, Martyn Lewis, Zeeshan Kibria, Fayaz Ahmad, Muhammad Firaz Khan, Mian Ul-Haq, Zia Ul-Haq, Noor Sanauddin, Mahnoor Majid, Maryiam Rahim, Farooq Naeem, Mirrat Butt, Saadia Ashraf, Ivan Komproe, Christian Mallen, Ian Kellar, Ghasem Yadegarfar, Abbie Milner, Saima Sheikh, Saeed Farooq
Publication date
2024/6/1
Journal
BMJ open
Volume
14
Issue
6
Pages
e083483
Publisher
British Medical Journal Publishing Group
Description
Introduction and objectives
There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan.
Methods
We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who …