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.
If you are accessing this page during weekend or evening hours, the database may currently be offline for maintenance and should operational within a few hours. Otherwise, we have been notified of this error and will be addressing it immediately.
Please contact us
if this error persists.
We apologize for the inconvenience.
- The DCCPS Team.