Grant Number:	5R01CA244185-05 Interpret this number
Primary Investigator:	Nelson, Christian
Organization:	Sloan-Kettering Inst Can Research
Project Title:	A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: a Mechanism-Targeted Approach to Addressing Caregiver Distress
Fiscal Year:	2024

PROJECT SUMMARY Informal caregivers (ICs) of patients with cancer, who play an increasingly crucial role in the healthcare system, are at significant risk for severe and persistent anxiety and depression, even higher than levels reported by the patients for whom they provide care. Cognitive behavioral therapy (CBT) has demonstrated robust efficacy for clinical anxiety and depression for individuals in the general population, but CBTs adapted for cancer ICs evidence comparatively unsatisfying outcomes. One possible explanation for this lackluster efficacy is that these CBTs do not comprehensively target the factors that typically comprise the distress commonly experienced by ICs, such as attentional rigidity and perseverative negative thinking (PNT; e.g., worry and rumination). Emotion Regulation Therapy (ERT) is a contemporary CBT intervention developed to deliberately target processes underlying the distress associated with caregiving. ERT has established efficacy and initial support for proposed mechanisms in a series of trials for chronic anxiety and depression and is a promising candidate intervention to address the mechanisms likely complicating the resolution of IC anxiety and depression. Predicated on ERT, we developed Emotion Regulation Therapy for Cancer Caregivers (ERT- C) and demonstrated feasibility, acceptability, and initial efficacy in reducing depression and anxiety symptoms, PNT and emotion regulation deficits, and improving the quality of life of patients for whom ICs enrolled in ERT-C provided care. In this application, we propose to more stringently evaluate the efficacy of ERT-C and elucidate hypothesized mechanisms underlying reductions in distress. Through a multi-site trial, we will randomize 200 ICs to 8 sessions each of ERT-C or traditional CBT to evaluate primary and secondary outcomes at baseline, post-treatment, and at 3-and 6-months follow-up. Patient outcomes will also be collected at baseline and 3-months follow-up. We predict that ERT-C will be associated with superior anxiety and depression reductions in ICs and QOL in patients, with advantages maintained six months following treatment. Secondarily, we predict that ERT will produce greater gains in adaptive emotion regulation capacity and that these skills will partially mediate reductions in depression and anxiety symptoms. We will additionally examine the relative change in salivary markers of stress (e.g., diurnal cortisol) and inflammation (i.e., soluble tumor necrosis factor-alpha receptor II, CRP, Interleukin 6) in ICs receiving ERT-C versus CBT and predict that ERT- C will result in greater reductions in cortisol dysregulation and systemic inflammation as compared to CBT, and these gains will be maintained at 6-months follow-up. Our results will advance the science of IC intervention research by addressing a critical gap in our field’s ability to powerfully, quickly and effectively address IC anxiety and depression.




Closing the Caregiving Gap: Considerations for Pancreatic and Periampullary Cancer Caregivers.
Authors: Willis K.D. , Jacobs J.M. .
Source: Jco Oncology Practice, 2023 Aug; 19(8), p. 523-525.
EPub date: 2023-06-29 00:00:00.0.
PMID: 37384851
Related Citations

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress.
Authors: Applebaum A.J. , Loschiavo M. , Morgan K. , Mennin D.S. , Fresco D.M. , Hoyt M.A. , Schofield E. , O'Toole M.S. , Cohn J. , Jacobs J.M. .
Source: Contemporary Clinical Trials, 2022 Nov; 122, p. 106923.
EPub date: 2022-09-14 00:00:00.0.
PMID: 36115638
Related Citations

Mindfulness-Based Cognitive Therapy: A Preliminary Examination of the (Event-Related) Potential for Modifying Threat-Related Attentional Bias in Anxiety.
Authors: Gupta R.S. , Kujawa A. , Fresco D.M. , Kang H. , Vago D.R. .
Source: Mindfulness, 2022-06-01 00:00:00.0; , p. 1-14.
EPub date: 2022-06-01 00:00:00.0.
PMID: 35668874
Related Citations

Preliminary Efficacy of an Emotion Regulation Intervention on Physical Activity and Depressive and Anxious Symptoms in Individuals in Cardiac Rehabilitation.
Authors: Wierenga K.L. , Fresco D.M. , Alder M. , Sattar A. , Moore S.M. .
Source: The Journal Of Cardiovascular Nursing, 2021-07-23 00:00:00.0; , .
EPub date: 2021-07-23 00:00:00.0.
PMID: 34321436
Related Citations