Trial reportAnnals of behavioral medicine : a publication of the Society of Behavioral Medicine2026
Randomized controlled trial of emotion regulation therapy versus cognitive behavioral therapy to address distress in cancer caregivers.
Trial report in Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04802720 (A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers), which is not on this map. Not yet cited in PubMed.
What it found
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The trial behind it
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A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress
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Authors and funding
9 authors.
Funding
Abstract
backgroundCognitive 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.
methodsWe 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.
resultsFrom 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.
conclusionsAlthough 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 registrationThis trial is registered on ClinicalTrials.gov (identifier: NCT04802720).
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