Effectiveness of Gross's emotion regulation training on death anxiety in leukemia patients undergoing chemotherapy: a randomized controlled trial

Abstract

BACKGROUND: Death anxiety is common among leukemia patients undergoing chemotherapy and can adversely affect quality of life. This randomized controlled trial evaluated the short-term effect of Gross's emotion regulation training on death anxiety in this population. METHODS: This single-blind (data analyst-blinded), parallel-group randomized controlled trial was conducted at Omid Hospital, Isfahan, Iran, in 2024. Sixty adult leukemia patients undergoing chemotherapy were randomized 1:1 to receive either six virtual sessions of Gross model-based emotion regulation training or standard care. Death anxiety was assessed using the Templer Death Anxiety Scale at baseline and immediately after the intervention. The primary analysis used a linear mixed-effects repeated-measures model including group, time, and group x time interaction as fixed effects and participant as a random effect. ANCOVA was considered but not retained because the homogeneity of regression slopes assumption was not supported. Mean differences, 95 confidence intervals, and Cohen's effect sizes were reported. Analyses were performed using SPSS v26, with alpha = 0.05. RESULTS: Baseline characteristics and death anxiety scores were comparable between groups. Baseline TDAS scores were 11.03 +/- 4.59 in the intervention group and 10.87 +/- 4.54 in the control group (mean difference = 0.17, 95 CI: -2.19 to 2.53; p = 0.888). Post-intervention scores decreased to 5.97 +/- 3.64 in the intervention group but remained relatively unchanged in the control group (11.07 +/- 4.67). The mixed-effects model showed a significant group x time interaction (beta = -5.27, 95 CI: -6.40 to - 4.13; p < 0.001). The post-intervention between-group difference was significant (mean difference = - 5.10, 95 CI: -7.26 to - 2.94; p < 0.001; Cohen's d = - 1.22). No adverse events were reported, and intervention adherence was 100. CONCLUSIONS: Virtual Gross model-based emotion regulation training was associated with a significant short-term reduction in death anxiety among leukemia patients undergoing chemotherapy. These preliminary findings should be interpreted considering the short-term assessment, single-center design, and absence of blinded outcome assessment. TRIAL REGISTRATION: IRCT20141127020108N5. Registered on September 7, 2022. ( https://irct.behdasht.gov.ir/).