Randomized controlled trial of emotion regulation therapy versus cognitive behavioral therapy to address distress in cancer caregivers.
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BACKGROUND: Cognitive Behavioral Therapy (CBT) shows promise for addressing distress in cancer caregivers, though results are mixed. Traditional CBT may not fully address transdiagnostic processes underlying caregiver distress, such as attentional rigidity and perseverative thinking. Emotion Regulation Therapy (ERT), a contemporary CBT targeting these mechanisms, has promise for cancer caregivers (ERT-C). We compared ERT-C to caregiver-adapted CBT (CBT-C) on caregiver- and patient-reported outcomes. METHODS: We conducted a multisite RCT (ERT-C vs. CBT-C) with distressed caregivers of patients with any cancer type or stage. Caregivers completed measures of anxiety, depression, worry, rumination, burden, and quality of life (QOL) at baseline, post-treatment, and 3- and 6-months follow-up. Patients reported outcomes at baseline and 3 months. Linear mixed-effects models with multiple imputation were used to assess group differences. RESULTS: From March 2021 to April 2024, we randomized 253 caregivers, of whom 244 were analyzed (ERT-C = 124; CBT-C = 120), and enrolled 95 patients (ERT-C = 47; CBT-C = 48), of whom 87 were analyzed. From pre- to post-treatment and through 6 months follow-up, caregivers in ERT-C did not improve significantly more than in CBT-C. Although there were significant between-group differences in patient physical and mental health, these effects did not persist after multiplicity adjustment. However, caregivers overall demonstrated significant improvements over time in anxiety, depression, worry, and QOL, and patients demonstrated significant improvements in perceived stress and emergency room visits. CONCLUSIONS: Although ERT-C was not superior to CBT-C, caregivers showed meaningful psychosocial improvements overall, and patients improved on 2 outcomes. Future work will examine whether the 2 treatments differentially engage putative mechanisms leading to the observed clinical findings. CLINICAL TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov (identifier: NCT04802720).