Effectiveness of a couple-based dyadic coping intervention on psychological distress and relationship functioning in HPV patients: a randomized controlled trial in China

Abstract

Background Human papillomavirus (HPV) infection may cause psychological distress and strain intimate relationships because concerns regarding transmission, stigma, and cancer risk can affect both patients and their partners. Evidence regarding HPV- specific couple-based psychosocial interventions remains limited. Objective To evaluate the effects of a couple-based dyadic coping intervention on psychological distress and relationship functioning in patients with HPV infection. Methods This randomized controlled trial enrolled 148 couples from a special-needs outpatient department, with the female partner in each couple diagnosed with HPV infection. Couples were randomly assigned in a 1:1 ratio to receive either an 8-week couple-based dyadic coping intervention plus routine care or routine care alone. The primary outcome was the change in the patient-reported Depression Anxiety Stress Scale-21 (DASS-21) total score from baseline to 8 weeks. Secondary outcomes included the HPV Impact Profile (HIP) total score and the patient- and spouse-reported Couples’ Illness Communication Scale (CICS), Dyadic Adjustment Scale (DAS), and Dyadic Coping Inventory (DCI) total scores. Follow-up compliance and HPV clearance were evaluated as exploratory outcomes. Between-group differences in changes were reported with 95% confidence intervals and Cohen’s d, and the robustness of the primary finding was further examined using multivariable ANCOVA and multiple imputation. Results A total of 142 couples completed the 8-week assessment (intervention group, n = 72; control group, n = 70). The intervention group showed a greater reduction in the DASS-21 total score than the control group (difference in change, −4.98 points; 95% CI, −7.51 to −2.45; Cohen’s d = −0.65; p < 0.001). The adjusted ANCOVA and multiple-imputation sensitivity analysis yielded consistent findings. Secondary total-score outcomes also favored the intervention, with absolute standardized effect sizes ranging from 0.68 to 0.89 (all Holm-adjusted p < 0.001). Complete follow-up compliance was higher in the intervention group than in the control group (75.0% vs. 45.7%; p = 0.001). HPV clearance at 3 months was numerically higher in the intervention group (38.9% vs. 24.3%), but the between-group difference was not statistically significant (p = 0.062). No serious adverse events were reported. Conclusion An 8-week couple-based dyadic coping intervention was associated with short-term improvements in psychological distress, HPV-specific impact, relationship functioning, dyadic coping, and follow-up compliance. The intervention shows promise as a supportive psychosocial approach but warrants confirmation in larger multicenter studies with longer follow-up before routine clinical implementation. The HPV clearance finding should be considered exploratory and hypothesis-generating.