Effect of Relaxation Techniques Combined With Cognitive Behavioural Therapy on Depression, Anxiety and Quality of Life Among Pulmonary Tuberculosis Patients in Northern Ethiopia: Multicentre Cluster Randomized Controlled Trial

Objective Depression and anxiety are prevalent among subjects with pulmonary tuberculosis (PTB), especially in lower‐middle‐income countries. CBT and RT are widely recognized psychological interventions. The study aimed to assess the effect of Relaxation Techniques (RT) combined with Cognitive Behavioural Therapy (CBT) on depression and anxiety symptoms and quality of life among patients with PTB. Methods A multicentre cluster randomized controlled trial was employed among participants. Hospitals were randomly divided into two equal groups using a computer‐generated algorithm. The intervention had seven sessions lasting for 3 months. Outcomes were measured at baseline, 7‐week and 3‐month post‐randomization for both groups with the same measures. A Linear Mixed‐Effect Model (LMM) was utilized for data analysis, with 95% CI and p value < 0.05. Results A total of 121 samples were included in the final analysis. The LMM findings indicated a significant Group*Time interaction across all outcomes ( p < 0.001). At 3‐month follow‐up, the RT‐CBT group demonstrated reduced depression scores compared with the control group (Mean difference (MD) = −4.95, 95% CI: −6.98, −2.92, p < 0.001; Cohen's d = −0.93). Significant reductions were also observed in anxiety scores among RT‐CBT groups (MD = −3.62, 95% CI: −4.30, −2.92, p < 0.001; Cohen's d = −1.14). Similarly, participants in the intervention group compared to control had greater improvements in quality of life (MD = 16.21, 95% CI: 12.93, 19.47, p < 0.001; Cohen's d = 1.08) and treatment adherence (MD = 2.40, 95% CI: 1.84, 2.96, p < 0.001; Cohen's d = 0.93). Conclusion The study demonstrated that RT‐CBT is effective for decreasing depression and anxiety and promoting improvements in quality of life and treatment adherence for individuals with PTB attending treatment follow‐up. The results support the integration of RT‐CBT into routine tuberculosis treatment clinics. Trial Registration The trial has been registered on ‘Pan African Clinical Trials Registry’ with trial number: PACTR202412822674360, registered on December 24, 2024, available at https://pactr.samrc.ac.za/