Development and preliminary evaluation of EMPOWER for surrogate decision-makers of critically ill patients

“For the first three participants enrolled, anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-itemmeasure of anxiety and depression used in both hospital and community settings (Zigmond and Snaith, 1983).”

“…Disorder-7 (GAD-7), a valid and reliable 7-item measure of generalized anxiety symptoms (scores ranging from 0 to 21) (Spitzer et al., 2006), and depression was measured with the widely used 9-item Patient Health Questionnaire-9 (PHQ-9), with scores ranging from 0 to 27 (Kroenke et al., 2001).”

“…using the Generalized Anxiety Disorder-7 (GAD-7), a valid and reliable 7-item measure of generalized anxiety symptoms (scores ranging from 0 to 21) (Spitzer et al., 2006), and depression was measured with the widely used 9-item Patient Health Questionnaire-9 (PHQ-9), with scores ranging from 0 to…”

“Consensus meetings were led by KER, and the codebook was iteratively modified as new themes were identified (Charmaz, 2004; Hill et al., 2005).”

“Both of these predict better bereavement adjustment of the caregiver (Wright et al., 2008; Garrido and Prigerson, 2014).”

“EMPOWER targets surrogates who are anxious and/or closely attached to the patient because these individuals are at greatest risk for developing poor outcomes, such as PTSD and PGD, following the patient’s death or discharge from the ICU (Bryant et al., 2008; Andrews et al., 2009; Prigerson et al., 2009; Gartlehner et…”

“Distress tolerance was indexed by the summed score of items 1, 2, 8, and 9 of the 14-item Distress Tolerance Scale (DTS), which assesses an individual’s ability to endure negative emotional states (Simons and Gaher, 2005).”

“To evaluate the preliminary effects of EMPOWER, we used descriptive statistics and Dunlap’s d within-subjects effect-size estimates (Dunlap et al., 1996) at each longitudinal timepoint relative to baseline.”

“Involvement in making end-of-life decisions appears to be a particularly significant source of stress (Azoulay et al., 2005).”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“The next step in developing EMPOWER is conducting a Stage IB feasibility randomized controlled trial to prepare for a larger-scale efficacy trial (Rounsaville et al., 2001).”

“This avoidance is likely to be detrimental, as advance care planning and goals of care discussions have been associated with higher quality, less aggressive, and more value-consistent end-of-life care, as well as better patient quality of life (Mack et al., 2010).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“…Scale) (Johnson et al., 2006; 2007), and be at least moderately anxious (greater than 5 on either anxiety item of the McGill Quality of Life Scale) (Cohen et al., 1995).1 Screening scores were selected based on pilot data, indicating that anxiety and attachment issues are key risks for poor coping…”

“76) and valid 13-item test that measures the extent to which an individual experienced distress at the time of a critical incident event and in the subsequent minutes or hours (Brunet et al., 2001; Bunnell et al., 2018).”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“Consensus meetings were led by KER, and the codebook was iteratively modified as new themes were identified (Charmaz, 2004; Hill et al., 2005).”

“Intervention and conceptual model description EMPOWER incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo…”

“Experiential avoidance was measured by the Brief Experiential Avoidance Questionnaire (BEAQ) (Gamez et al., 2014), a 15-item measure assessing six dimensions of experiential avoidance that has demonstrated good internal consistency.”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“Part 1 used a modified Delphi approach that involved gathering opinions from experts, keeping feedback anonymous, identifying and summarizing feedback themes, and circulating modifications back to experts until consensus is reached (de Meyrick, 2003).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“The surrogate’s ability to tolerate distress in real time and throughout the EMPOWER encounter are highlighted to help increase acceptance of these aversive states and foster selfcompassion (Orsillo and Batten, 2005; Walser andWestrup, 2007).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“2009), and postloss PGD symptom severity was assessed by the widely used, valid, 13-item PG-13 (Zhang et al., 2006; Prigerson et al., 2008, 2009).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“2009), and postloss PGD symptom severity was assessed by the widely used, valid, 13-item PG-13 (Zhang et al., 2006; Prigerson et al., 2008, 2009).”

“Intervention and conceptual model description EMPOWER incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo…”

“preserve the patient’s life, and the need to protect the welfare of their family (Schenker et al., 2012).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al.”

“Intervention and conceptual model description EMPOWER incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo…”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“Intervention and conceptual model description EMPOWER incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo…”

“…incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo and Batten, 2005; Walser and Westrup, 2007;…”

“Both of these predict better bereavement adjustment of the caregiver (Wright et al., 2008; Garrido and Prigerson, 2014).”

“…are anxious and/or closely attached to the patient because these individuals are at greatest risk for developing poor outcomes, such as PTSD and PGD, following the patient’s death or discharge from the ICU (Bryant et al., 2008; Andrews et al., 2009; Prigerson et al., 2009; Gartlehner et al., 2013).”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“The measure has demonstrated reliability in caregivers (α = 0.85 for anxiety; α = 0.84 for depression) (Gough and Hudson, 2009).”

“However, prior intervention trials have produced mixed results (Lautrette et al., 2007; White et al., 2012, 2018; Curtis et al., 2013; Carson et al., 2016; Cox et al., 2019; Dionne-Odom et al., 2020).”

“, 2015; McLean and Follette, 2016), and meaning-centered grief therapy techniques (Lichtenthal et al., 2019; Neimeyer, 2012, 2016) to reduce experiential avoidance and symptoms of anxiety, grief, and traumatic stress.”

“…tolerance (Orsillo and Batten, 2005; Walser and Westrup, 2007; Kelly et al., 2015; McLean and Follette, 2016), and meaning-centered grief therapy techniques (Lichtenthal et al., 2019; Neimeyer, 2012, 2016) to reduce experiential avoidance and symptoms of anxiety, grief, and traumatic stress.”

“76) and valid 13-item test that measures the extent to which an individual experienced distress at the time of a critical incident event and in the subsequent minutes or hours (Brunet et al., 2001; Bunnell et al., 2018).”

“EMPOWER incorporates evidence-based cognitive-behavioral approaches (Bryant et al., 2003, 2008, 2014; Boelen et al., 2007; Gartlehner et al., 2013; Litz et al., 2014; Birur et al., 2016), acceptance-based principles to build distress tolerance (Orsillo and Batten, 2005; Walser and Westrup, 2007; Kelly et al.”

“…avoidance is an important predictor of psychiatric disorders, including depression, anxiety, prolonged grief, and PTSD (Marx and Sloan, 2005; Spinhoven et al., 2016, 2017; Williams et al., 2019; Serrano-Ibanez et al., 2021), reducing such avoidance may have longer-term psychological…”

“Decision-making self-efficacy was measured by the Family Decision-Making Self-efficacy Scale: Unconscious Patient Scenario (FDMSS), a 13-item valid and reliable assessment of confidence of family members in their ability to make decisions with or for a terminally ill loved one (Nolan et al., 2009).”

“The identification of facilitators and barriers to future dissemination and implementation of EMPOWER should also be a focus, including how the intervention may integrate into bereavement services (McAdam and Erikson, 2016).”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“…to be English-speaking, report a very close attachment to the patient (a summed score of at least 8 on two items from the Partner Dependence Scale) (Johnson et al., 2006; 2007), and be at least moderately anxious (greater than 5 on either anxiety item of the McGill Quality of Life Scale) (Cohen et…”

“momentary experiential avoidance (Levin et al., 2018), in future trials.”

“By reducing experiential avoidance, surrogates’ ability to tolerate distress and be emotionally activated (Fernandez-Rodriguez et al., 2018) during the ICU stay may increase.”

“It invites an imaginal dialogue with the patient to garner the patient’s support in the surrogate’s struggle to consider the patient’s wishes and values, and to facilitate quality decisionmaking and empowerment (Tunzi, 2012; Cox et al., 2015).”

“…the McGill Quality of Life Scale) (Cohen et al., 1995).1 Screening scores were selected based on pilot data, indicating that anxiety and attachment issues are key risks for poor coping among caregivers (Prigerson et al., 2009; Wright et al., 2010; Garrido and Prigerson, 2014; Higgins et al., 2015).”

“, 2016), acceptance-based principles to build distress tolerance (Orsillo and Batten, 2005; Walser and Westrup, 2007; Kelly et al., 2015; McLean and Follette, 2016), and meaning-centered grief therapy techniques (Lichtenthal et al.”

“…to be English-speaking, report a very close attachment to the patient (a summed score of at least 8 on two items from the Partner Dependence Scale) (Johnson et al., 2006; 2007), and be at least moderately anxious (greater than 5 on either anxiety item of the McGill Quality of Life Scale) (Cohen et…”

“, on ventilator, unconscious, or cognitively impaired rendering them unable to talk), admitted to an ICU or step-down unit during their current hospitalization, and considered by the ICU attending or fellow to be near the end of life (patients whose ICU physicians or fellows would not be surprised if they did not surv…”

“Introduction Research has repeatedly shown that surrogate decision-makers of critically ill patients receiving intensive care are at heightened risk of significant psychological distress, including posttraumatic stress disorder (PTSD) and prolonged grief disorder (PGD) (Anderson et al., 2008; Siegel et al., 2008; Wrig…”

“The focus on providing individually tailored tools for higher-risk individuals distinguishes EMPOWER from interventions like critical incident stress debriefing (Mitchell and Everly, 1995; Gartlehner et al., 2013).”

“Our conceptual model posits that symptoms of grief, anxiety, traumatic stress, and related maladaptive coping reactions, such as dissociation and avoidance, interfere with engaging in valueconcordant and empowered end-of-life decision-making (Glick et al., 2018).”

“We developed and pilot tested a brief mental health intervention called EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Emotional Resilience), which uses ultra-brief (Sperry and Binensztok, 2019), evidence-based cognitive-behavioral, acceptance-based techniques to reduce experiential avoidance, grief,…”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“We highlight the role in coping of experiential avoidance, which is the natural tendency to avoid unpleasant feelings and consideration of negative outcomes (Plumb et al., 2004; Gamez et al., 2011, 2014) and which has been associated with PTSD and PGD (Marx and Sloan, 2005; Bishop et al., 2018; Williams et al., 2019;…”

“It additionally provides a space to do their “due diligence” in reflecting on their and the patient’s values and circumstances, so that they may feel empowered in the decision-making process (Tunzi, 2012).”

“EMPOWER was designed to be adaptable to the fast-paced, often chaotic, ICU milieu, using ultra-brief, evidence-based interventions (Sperry and Binensztok, 2019) to reduce peritraumatic stress, grief, anxiety, and experiential avoidance.”

“Many were reporting on pilot programs or included extremely small sample sizes (e.g., less than 15 people per group) which may be more amenable to Type I errors (e.g., Bloom et al., 2020; Brown et al., 2014; Good-win et al., 2012; Lichtenthal et al., 2022; Russell et al., 2019; Sauer et al., 2022).”

“, engaging in psychological counseling to promote emotional preparedness for the relative's death) which warrant investigation to guide further interventions as one pilot intervention study demonstrated.(39) As commonly occurs in observational studies, our outcomes may have been influenced by unmeasured factors, for”

“EMPOWER is a psychological intervention composed of six modules based on cognitive-behavioural and acceptance-based interventions: 1) initial assessment, rationale and adherence to the intervention; 2) resources for stabilization; 3) psychoeducation on grief and the cognitive-behavioural model; 4) promoting experienti…”

“…participant outcomes pertaining to ‘Quality of life and mental wellbeing’ were reported in the dimensions of relationships and social functioning, positive mental wellbeing [29], and negative mental and emotional state (Table 3 of the Supplementary Material) [14, 16, 30, 33, 34, 39, 56, 60, 63].”

“The PG-12-R has demonstrated strong internal consistency [47] and is administered at T1– T4 to non-bereaved caregivers.”

“Reducing experiential avoidance is viewed in this program as a central mechanism of change, enabling individuals to engage more openly with their emotional pain and foster acceptance and resilience (Lichtenthal et al., 2022; Kaiser et al., 2022).”