Skip to main content

Research Repository

Advanced Search

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot.

Fonseka, Nishani; Khan, Zohaib; Lewis, Martyn; Kibria, Zeeshan; Ahmad, Fayaz; Khan, Muhammad Firaz; Ul-Haq, Mian; Ul-Haq, Zia; Sanauddin, Noor; Majid, Mahnoor; Rahim, Maryiam; Naeem, Farooq; Butt, Mirrat; Ashraf, Saadia; Komproe, Ivan; Mallen, Christian; Kellar, Ian; Yadegarfar, Ghasem; Milner, Abbie; Sheikh, Saima; Farooq, Saeed

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



Abstract

Introduction and objectivesThere 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.MethodsWe 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 started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy.Ethics and disseminationEthical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers.Trial registration numberISRCTN10761003.

Citation

Fonseka, N., Khan, Z., Lewis, M., Kibria, Z., Ahmad, F., Khan, M. F., …Farooq, S. (2024). Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot. BMJ Open, 14(6), Article e083483. https://doi.org/10.1136/bmjopen-2023-083483

Journal Article Type Article
Acceptance Date Feb 28, 2024
Online Publication Date Jun 17, 2024
Publication Date Jun 1, 2024
Deposit Date Jul 1, 2024
Publicly Available Date Jul 1, 2024
Journal BMJ open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 14
Issue 6
Article Number e083483
DOI https://doi.org/10.1136/bmjopen-2023-083483
Keywords Tuberculosis, Mental health, Depression & Mood Disorders, Humans, Antitubercular Agents, Pilot Projects, Depression, Adult, Cost-Benefit Analysis, Pakistan, Multicenter Studies as Topic, Pragmatic Clinical Trials as Topic, Cognitive Behavioral Therapy
Public URL https://keele-repository.worktribe.com/output/859785
Publisher URL https://bmjopen.bmj.com/content/14/6/e083483
PMID 38889941

Files

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot. (624 Kb)
PDF

Copyright Statement
cc by-nc






You might also like



Downloadable Citations