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

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.