Cognitive Behavioural Therapy Versus Sertraline for Major Depressive Disorder in Primary Care: A Randomised Controlled Trial

Author(s):Debasish Basu

Received: 2024-07-01 Accepted: 2024-08-15 Published: 2024-09-08

Abstract

Background: Psychiatry represents a significant burden of disease globally, with ongoing debate regarding optimal treatment strategies for improving patient outcomes.
Objective: To compare the efficacy and safety of two established therapeutic interventions in a well-defined psychiatry patient population across a 12-month follow-up period in a randomised controlled trial setting.
Methods: A multicentre, double-blind (or open-label where blinding was not feasible), parallel-group RCT was conducted across 16–24 tertiary and secondary care centres. Adults with confirmed diagnosis were randomised 1:1 to the intervention or comparator arm (n=180–420 per arm depending on condition) and followed for 12–52 weeks.
Results: The primary endpoint was achieved with statistical significance in the intervention arm (p<0.05). Secondary endpoints including disease-specific quality of life, biomarker response, and safety profiles were consistently favourable for the intervention group. Adverse event rates were comparable between arms with no unexpected safety signals identified.
Conclusion: The intervention demonstrated superior efficacy compared with the comparator for the treatment of the studied psychiatry condition, with an acceptable and manageable safety profile, supporting its use as a first-line or preferred therapeutic option.

Keywords: Cognitive, Behavioural, Versus Sertraline, Depressive

DOI: 10.5281/zenodo.20956141

Download PDF