Effectiveness of Gross’s emotion regulation training on death anxiety in leukemia patients undergoing chemotherapy: a randomized controlled trial
摘要
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.
MethodsThis 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 × 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 α = 0.05.
ResultsBaseline 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 × time interaction (β = −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%.
ConclusionsVirtual 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 registrationIRCT20141127020108N5. Registered on September 7, 2022. (https://irct.behdasht.gov.ir/).