Objective: To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Method: Selective qualitative review. Results: Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusions: This review highlights the need for a scientific consensus statement on control groups in behavioral trials. CUC = constrained usual care; EP = existing practice; EUC = enhanced usual care; eEUC = extensively enhanced usual care; HIV = human immunodeficiency virus; IC = inadequate care; iSOC = individualized standard of care; mEUC = minimally enhanced usual care; PMR = progressive muscle relaxation; RC = routine care; RCT = randomized controlled trial; SC = standard care; SOC = standard of care; uSOC = uniform standard care; STR = standardized treatment regimen; TAU = treatment-as-usual; UC = usual care

The beneficial effects of self-care include improved well-being and lower morbidity, mortality, and healthcare costs. In this article we address the current state of self-care research and propose an agenda for future research based on the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019. The vision of this Center is a world where self-care is prioritized by individuals, families, and communities and is the first line of approach in every health care encounter. The mission of the Center is to lead the self-care research endeavor, improving conceptual clarity and promoting interdisciplinary work informed by a shared vision addressing knowledge gaps. A focused research agenda can deepen our theoretical understanding of self-care and the mechanisms underlying self-care, which can contribute to the development of effective interventions that improve outcomes. During conference discussions, we identified seven major reasons why self-care is challenging, which can be grouped into the general categories of behavior change and illness related factors. We identified six specific knowledge gaps that, if addressed, may help to address these challenges: the influence of habit formation on behavior change, resilience in the face of stressful life events that interfere with self-care, the influence of culture on self-care behavioral choices, the difficulty performing self-care with multiple chronic conditions, self-care in persons with severe mental illness, and the influence of others (care partners, family, peer supporters, and healthcare professionals) on self-care. To achieve the vision and mission of the Center, we will lead a collaborative program of research that addresses self-care knowledge gaps and improves outcomes, create a supportive international network for knowledge transfer and support of innovations in self-care research, and support and train others in self-care research. Beyond these specific short-term goals, important policy implications of this work are discussed.

Major depression is a common comorbidity in heart failure (HF).^1-3 It is associated with poor quality of life^4,5 and an increased risk for hospitalization^6-10 and mortality.^6,9,11,12 It is also difficult to treat. Sertraline Against Depression and Heart Disease in Chronic Heart Failure(SADHART-CHF) is the largest (n = 469) randomized clinical trial (RCT) to date of an antidepressant for major depression in HF. There was no difference in posttreatment depression between the sertraline and placebo arms.¹³ More recently, the Mortality, Morbidity, and Mood in Depressed Heart Failure Patients (MOOD-HF) trial¹⁴ found no difference in posttreatment depression between the escitalopram and placebo arms in 372 patients with heart failure.¹⁵ There are well-established behavioral treatments for depression in psychiatric patients,¹⁶ but little is known about their efficacy for comorbid major depression in HF.

To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions. The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators. The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account. We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

Approximately 1 in every 5 patients meets the DSM-IV criteria for a major depressive episode during recovery from coronary artery bypass graft (CABG) surgery,^1,2 and at least as many experience milder forms of depression.^3,4 Depression around the time of surgery predicts postoperative complications, longer physical and emotional recovery, worse quality of life, and increased rates of cardiac events and mortality.^5-10 In addition, perceived cognitive impairment after CABG surgery is worse in depressed than nondepressed patients with comparable profiles on objective neuropsychological tests.¹¹