A Health App for Post-Pandemic Years (HAPPY) for people with physiological and psychosocial distress during the post-pandemic era: Protocol for a randomized controlled trial.

ABSTRACT

Objective: This article describes a protocol for a randomized controlled trial to evaluate the effects of a three-level Health App for Post-Pandemic Years (HAPPY) on alleviating post-pandemic physiological and psychosocial distress. Methods: Convenience and snowball sampling methods will be used to recruit 814 people aged 18+ with physiological and/or psychosocial distress. The experimental group will receive a 24-week intervention consisting of an 8-week regular supervision phase and a 16-week self-help phase. Based on their assessment results, they will be assigned to receive interventions on mindfulness, energy conservation techniques, or physical activity training. The waitlist control group will receive the same intervention in Week 25. The primary outcome will be changes in psychosocial distress, measured using the Kessler Psychological Distress Scale (K10). Secondary outcomes will include changes in levels of fatigue (Chinese version of the Brief Fatigue Inventory), sleep quality (Chinese version of the Pittsburgh Sleep Quality Index), pain intensity (Numeric Rating Scale), positive appraisal (Short version of the 18-item Cognitive Emotion Regulation Questionnaire), self-efficacy (Chinese version of the General Self-efficacy Scale), depression and anxiety (Chinese version of the 21-item Depression Anxiety Stress Scale), and event impact (Chinese version of the 22-item Impact of Event Scale-Revised). All measures will be administered at baseline (T0), Week 8 after the supervision phase (T1), and 24 weeks post-intervention (T2). A generalized estimating equations model will be used to examine the group, time, and interaction (Time × Group) effect of the interventions on the outcome assessments (intention-to-treat analysis) across the three time points, and to compute a within-group comparison of objective physiological parameters and adherence to the assigned interventions in the experimental group. Conclusions: The innovative, three-level mobile HAPPY app will promote beneficial behavioral strategies to alleviate post-pandemic physiological and psychosocial distress. Trial registration ClinicalTrials.gov, NCT05459896. Registered on 15 July 2022.