A culturally adapted mobile cognitive behavioral therapy for individuals with Hepatitis B on depression, anxiety and stress: A pilot randomized controlled trial

Abstract

Hepatitis B Virus (HBV) is a major global public health concern, with chronic infection affecting physical, psychological, social and work functioning, often leading to depression, anxiety, and stress. However, tailored online psychological interventions remain limited. This pilot randomized controlled trial aimed to evaluate the feasibility, acceptability and efficacy of a culturally-adapted four-week mobile cognitive-behavioral intervention for reducing depression, anxiety, and stress levels among individuals with HBV in China. Thirty-seven HBV-positive participants (age 18–65) with moderate to severe depression, anxiety or stress were recruited through an online platform. Participants were randomly assigned to an intervention group (n = 19) or waitlist control (n = 18). The intervention included animated psychoeducation, interactive exercises, and weekly feedback from trained clinical psychology graduates. Primary outcomes—depression, anxiety, and stress—were assessed weekly (T0–T4), while secondary outcomes—fatigue, cognitive flexibility, and post-traumatic stress—were measured at baseline (T0) and post-intervention (T4). Results showed that the intervention was feasible, with no serious adverse events reported. Participants in the intervention group completed an average of 43.2 % of the program and reported high satisfaction with it. Intention-to-treat repeated-measures ANOVA indicated significant improvements in depression and anxiety for both groups but found no significant differences between groups in primary or secondary psychological outcomes. This pilot study underscores the need to refine intervention content and delivery methods. Larger trials are needed to evaluate the efficacy of online psychological interventions for individuals with HBV and to explore strategies for enhancing engagement and adherence.