Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research

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Abstract

Intervention studies conducted in caregivers often focus on improving mental health. Consequently, researchers may discover incidental findings like elevated depressive symptoms. Researchers have an ethical obligation to report incidental findings to participants, but no protocols exist for reporting behavioral health symptoms. The purpose of this paper was to describe a protocol for reporting elevated depressive symptoms to participants, based on the protocol used in a national randomized clinical trial of stress-reduction methods for 348 grandmothers raising grandchildren. Each questionnaire included the CES-D scale, and was scored immediately after completion. We established a cut-off score of 30 based on previous research. A registered nurse on the research team called participants with scores over 30 and ascertained whether the participant 1) was aware of the problem and 2) had sought help, and then offered additional resources. Overall, 94 (27%) participants had a CES-D score > 30. The majority (91%) were aware of the problem. About a third of the participants were on medication for their symptoms, and a third were seeing a therapist. Nine participants were not aware they had depressive symptoms. This paper outlines the ethical premise for developing our protocol, details of protocol development, and discussion for how research teams can apply this protocol to their work.

Introduction

The ethical principle of beneficence obligates researchers to report incidental findings to participants (Ells and Thombs, 2014). While much of the literature regarding reporting incidental findings refers to reporting genetic variants or masses discovered via radiographic technologies (Wolf et al., 2008), the obligation to report verified, actionable findings to participants extends to behavioral health research (U.S. Department of Health and Human Services, 2019). The Secretary's Advisory Committee on Human Research Protections (SACHRP) recommends that if a validated measure discovers an incidental finding, and if that incidental finding is actionable, the incidental finding is “probably indicated” to be reported to the participant (U.S. Department of Health and Human Services, 2019). An elevated score on the Center for Epidemiologic Studies-Depression Scale (CES-D) (Radloff, 1977) of depressive symptoms is one example of an incidental finding that may need to be reported to participants in behavioral health research as the CESD scale meets the validated and actionable criteria.

Depression is a significant health condition that, if left untreated, can lead to poor functioning at work or at home, decreased quality of life, and possibly death (Cassano and Fava, 2002). Numerous treatments exist to treat and manage depression (McCoy et al., 2019) and the CESD scale is a well-validated tool for evaluating depressive symptoms in community-dwelling populations (Vilagut et al., 2016). Nationally 8% of individuals in the US experience depression, with an incidence rate two times higher in women than men (Pratt and Brody, 2014). Additionally, 12.3% of women in the US between the ages of 40 and 59 experience depression (Pratt& Brody, 2014). Despite the prevalence of depression and depressive symptoms and associated adverse health outcomes, researchers measuring depressive symptoms have few resources to guide them in the community to report elevated scores to participants. Having a protocol for doing so is supported by the work of Sheehan and McGee (2013) who also articulate the need to communicate elevated depression symptoms to participants. While there is consensus that depressive symptoms should be reported to participants, no clear guidelines or protocols for relaying information about depressive symptoms to participants in community-based settings exist in the literature. The aim of this paper is to describe a protocol and outcomes for reporting elevated CES-D scores to participants in a national, online, randomized clinical trial of interventions to reduce stress in grandmother caregivers.

Section snippets

Materials and methods

We enrolled 348 women in an online randomized clinical trial testing two interventions to reduce stress in grandmother caregivers. After consent was obtained, women enrolled in the study completed a baseline questionnaire, 4 weeks of journaling per intervention arm instructions, and a questionnaire two weeks, six weeks and four months after journal completion. Each questionnaire included the CES-D scale (Radloff, 1977). All procedures were approved by the Case Western Reserve University

Sample

Our 348 participants ranged in age from 36 to 80 (mean 56.19, SD 7.59), nearly half (49.71%) were married or living with a partner, and nearly half worked at least part-time (48.83%). Grandmothers of color comprised 28.36% of our sample, and 8.19% of our sample identified as Latina. All of our participants lived with at least one in-home grandchild, either as the primary custodian of the child(ren), or as part of a multigenerational household that included one or both parents of the

Determining cut-off score

In the general population, a score of 16 or greater indicates elevated risk of depression (Radloff, 1977; Vilagut et al., 2016). Previous studies have used higher cut off scores ranging from 20 to 34, especially in high-risk populations (Thomas et al., 2001; Vilagut et al., 2016). Sheehan and McGee (2013) recommend using tools that have a sensitivity and specificity above 90% when reporting incidental findings. While no cut of score for the CES-D reaches a sensitivity of 90%, the cut-off score

CES-D protocol

The protocol is illustrated in Fig. 1. The CES-D scale was part of each questionnaire and was calculated immediately after the questionnaire was returned. If a participant had a CESD score over 30, a registered nurse (RN) on the study team called the participant. If the participant did not answer, the RN left a message stating “we have a couple of follow up questions for you from your last questionnaire if you can give us a call back at your earliest convenience”. If a participant answered the

Results

Out of 348 participants, 94 had a CESD score over 30. Of the 94 with an elevated score, we were able to contact 87. The average CESD score for the participants we called was 36 (SD = 5.2), while the average CESD score for the total sample at the baseline was 18 (SD = 11.57, Range: 0–50). Eight out of the 87 participants we reached were not aware they had elevated symptoms of depression. One-third of the participants were seeing a therapist and one-third were taking medication. Seventeen percent

Discussion

To the best of our knowledge, this is the first published protocol detailing a process for relaying elevated depression symptoms directly to participants for a national online study. One previous study regarding an intervention for victims of intimate partner violence reported that they have an automated response of “it's important that you tell someone you trust how you are feeling” for individuals that answered affirmatively that they are “feeling down” on the CESD scale (Koziol-Mclain et

Funding support

This work was support by National Institutes of Health/National Institute of Nursing Research [R01NR015999].

Declaration of competing interest

The authors have no conflicts of interest to declare

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