Discontinuing the Term "Stakeholder" From the NIA IMPACT Collaboratory Engaging Partners Team: An Example of the Process of Language Change in an Organization.

In this paper, we describe our process of changing language of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease and AD-related dementias Clinical Trials Collaboratory (NIA IMPACT Collaboratory) "Stakeholder Engagement Team" to "Engaging Partners Team" in response to feedback from community partners regarding the problematic connotations of the term "stakeholder." We present a brief history of the term "stakeholder" and its use in clinical and community-engaged research. Then, we summarize critiques of this term, including its colonial history and potential to reinforce complacency with generational traumas, particularly among Indigenous peoples and communities. We conclude with a detailed overview of our team and organization's multi-step process to discontinue use of the term "stakeholder," in alignment with a theoretical model of organizational behavior change. This paper highlights the importance of critically evaluating language and responding to community partners. We hope our process can guide other researchers and organizations.

Flexibly Incorporating the Dyad into Psychosocial Intervention: Considerations for Neuropalliative Care.

This paper reviews dyadic psychosocial intervention approaches that flexibly incorporate both dyad members despite challenges to equitable involvement due to cognitive limitations or limited availability. We provide an overview, analysis, and examples for the following dyadic intervention approaches: (1) shared interventions that involve each dyad member equitably (i.e., higher care recipient cognition, higher care-partner availability); (2) patient-focused interventions that primarily engage care recipients with early stages of neurocognitive disorders, yet include care-partners in select sessions and target dyadic and relationship needs (i.e., higher care recipient cognition, lower care-partner availability); and (3) care-partner focused interventions that primarily engage care-partners, yet still address care recipient and relationship needs (i.e., lower care recipient cognition, higher care-partner availability). In our review, we propose a flexible definition of dyadic psychosocial intervention that considers the continuum of individuals' involvement, measurement, content, and conceptual background. We conclude with a discussion of implications for neuropalliative care.

Psychiatric Screening Measures in Behavioral Variant Frontotemporal Dementia.

OBJECTIVE: Behavioral variant frontotemporal dementia (bvFTD) is sometimes misdiagnosed as a primary psychiatric disorder, such as major depressive disorder, bipolar disorder, an anxiety disorder, autism spectrum disorder (ASD), or attention-deficit hyperactivity disorder (ADHD). Nonspecialists often use screening measures for primary psychiatric disorders in early assessments of persons with bvFTD. The investigators aimed to evaluate the manifestations of bvFTD in surveys intended to screen for primary psychiatric disorders. METHODS: Patients with bvFTD (N=27) presenting to an academic neurobehavior specialty clinic and their caregivers were provided questionnaire packets including the Mood Disorder Questionnaire (MDQ), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 scale (GAD-7), the Adult ADHD Self-Report Scale, version 1.1, the Ritvo Autism and Asperger Diagnostic Scale, and the Neuropsychiatric Inventory Questionnaire. Established cutoff scores suggesting the presence of a primary psychiatric disorder were used to define a "positive" response. Individual questions from each screening questionnaire were examined for a more granular characterization of bvFTD. RESULTS: Overall, 15% of bvFTD patients screened positive for bipolar disorder, 54% screened positive for ADHD, and 89% screened positive for ASD. Hyperactivity or hypersensitivity symptoms were infrequently endorsed. In addition, 57% of respondents screened positive for depressive symptoms on the PHQ-9, and 43% screened positive for anxiety symptoms on the GAD-7. CONCLUSIONS: The use of cutoff scores on screening measures for primary psychiatric disorders resulted in potentially problematic positive screens of primary psychiatric disorders among persons with bvFTD. Identifying specific questions that distinguish between bvFTD and primary psychiatric disorders requires further study.

Psychosocial Distress Among Certified Nursing Assistants in Long-Term Care During the COVID-19 Pandemic: A Social Ecological Model Informed Scoping Review.

OBJECTIVES: This scoping review maps the literature on psychosocial distress and coping among nursing assistants (CNAs) in long-term care facilities (LTC) during the COVID-19 pandemic onto the Social Ecological Model (SEM) of Occupational Stress. METHODS: Searches yielded 862 unique studies. Inclusion criteria were sample CNAs or equivalent in LTC; includes psychosocial variable; and collect data from February 2020-. A multi-phasic, meta-synthesis was used to synthesize qualitative data. RESULTS: We identified 20 studies (13 quantitative, 7 qualitative) conducted between March 2020 and December 2021 from 14 countries. Prevalence rates were reported for perceived stress (31-33%; n = 1 study), post-traumatic stress (42%; n = 1), anxiety (53%; n = 1), depression (15-59%; n = 2), suicidal thoughts (11-15%; n = 1), and everyday emotional burnout (28%; n = 1). Qualitative studies identified factors contributing to psychosocial distress and coping at each SEM level (i.e. individual, microsystem, organization, and peri-/extra-organizational). Quantitative studies primarily measured factors relating to psychosocial distress and coping at the individual and organizational levels. CONCLUSIONS & CLINICAL IMPLICATIONS: This review identifies specific targets for intervention for psychosocial distress among CNAs in LTC at multiple levels, including job clarity; workload; facility culture; community relations; and policy. These intervention targets remain relevant to the LTC industry beyond the context of the COVID-19 pandemic.

Psychological flexibility in older adulthood: a scoping review.

OBJECTIVES: Psychological flexibility/inflexibility (PF/PI) is a core component of the acceptance and commitment therapy (ACT) model, which is gaining more attention in the geropsychological literature. This scoping review examines the size and scope of the research on PF/PI in older adulthood related to age differences between older adult and younger samples, correlates relevant to psychological health, and changes with ACT. METHODS: A systematic literature search was conducted using PubMed, CINAHL, and PsycINFO. Peer-reviewed articles available in English were included that: had a mean age ≥65 and a minimum age ≥60; and reported self-report measures of PF/PI. We categorized PF/PI into three domains: open, aware, and engaged. RESULTS: Forty-six articles were included. Most studies measured open or aware domains; few measured the engaged domain. Older adults evidenced greater awareness compared to younger adults (9 of 13 analyses were significant). Openness and awareness consistently yielded medium to large correlations with anxiety and depression. PF/PI did not relate with positive affect and inconsistently correlated with quality of life measures. CONCLUSION: Despite emerging trends, variability and limitations were evident in the literature. Specifically, measurement issues, lack of conceptual clarity, and the omission of values and behavioral measures require future attention.

Advanced-Comfort: Usability Testing of a Care Planning Intervention for Nursing Home Residents With Advanced Dementia.

Many nursing home (NH) residents with advanced dementia receive burdensome interventions rather than interventions that promote comfort or quality of life. The purpose of the current study was to test the usability of a novel intervention, ADVANCED-Comfort, which aims to enhance the provision of personalized care for residents with advanced dementia. The intervention comprises structured care plan meetings between the NH team and proxies of residents with dementia (e.g., family members). Using the ADVANCED-Comfort workbook, proxies create individualized care plans addressing six domains adapted from the Age-Friendly Health System Framework. The purpose of this article is to describe the intervention and its theoretical underpinnings and report the usability of the intervention evaluated with surveys, observation, and exit interviews. The study demonstrated that proxies and NH staff found the intervention usable (acceptable, appropriate, and feasible). Based on these preliminary findings, additional testing of the ADVANCED-Comfort intervention is warranted. [Journal of Gerontological Nursing, 49(11), 15-23.].

Music for your mental health? The development and evaluation of a group mental health intervention in subacute rehabilitation.

Objectives: Short-stay residents of nursing homes experience high rates of mental health (MH) distress compared to community dwelling counterparts, yet MH interventions are difficult to implement and sustain. We modified a music therapy framework to Effective Music in Psychotherapy. Using the modified model, we integrated music listening into MH group intervention and evaluated MH outcomes. This pilot study reports the development and evaluation of the Mental Health and Music Group for short-stay nursing homes residents.Method: The group was developed and refined to be non-sequential and non-cumulative, specific to the needs of short-stay nursing home residents. Pre-/post-session ratings examined affect, quality of life, and pain. Leaders monitored engagement across and between sessions. Qualitative interviews were conducted with a selection of attendees.Results: Findings indicated decreases in irritation and worry, and increases in mood, energy, and self-as-a-whole from pre- to post-session. There were no changes in pain, perception of physical health or life-as-a-whole, energetic, sad, or happy affect, or differences in engagement. Qualitative interviews demonstrated benefits of group modality and music to group cohesion and highlighted the relevance of music for mental health outcomes.Conclusion: The Mental Health and Music group was designed around a framework of Effective Music in Psychotherapy, for short-stay nursing home settings, and demonstrated promising results. Future research can solidify the interventions generalizeability to medical and rehabilitation settings addressing the specific population needs and preferences.Supplemental data for this article is available online at https://doi.org/10.1080/13607863.2021.1935463 .

"You Lose Some Good Friends": Death and Grief in Assisted Living.

The purpose of this study was to investigate responses to death at multiple levels within the assisted living (AL) system and to characterize the psychosocial impact of death on surviving residents. This study used secondary thematic analysis of multiple data sources collected as part of a larger quantitative-focused study with 21 ALs. Data sources included: (a) community documents, e.g., newsletters; (b) descriptive and reflective observational field notes; and (c) memos and key statements from interviews with residents (n = 18). Three themes emerged from the data: administrative memorialization practices, resident perceptions of staff communication related to death, and resident psychosocial responses to death. Surviving residents reported using both adaptive and avoidant strategies to cope with psychological responses to death; noting that grief responses extended to the loss of the deceased resident's family, friends, and pets. Residents also perceived staff-resident communication and community memorialization practices as incongruent with a "family-like" social climate. Findings highlight the potential utility of a multi-level approach to improving psychosocial aspects of end-of-life care and grief management by targeting AL administration, workforce, and individuals. Social workers are well-positioned to lead these types of psychosocial interventions but must contend with staffing barriers limiting clinical roles in AL.

Interdisciplinary neuropalliative care: A unique and valuable clinical training experience for geropsychology trainees.

To address workforce issues in professional geropsychology, clinical training sites must offer opportunities to build skills for working with older adults and aging families. Neuropalliative care (NPC) may offer a valuable learning environment for geropsychology trainees to develop professional competencies, while positively contributing to patient care. This article describes a novel clinical rotation for an advanced geropsychology trainee in an interdisciplinary specialty NPC clinic. A co-assessment model emerged as a useful strategy for integrating the trainee into the established NPC team. Two case examples illustrate the co-assessment's ability to enhance: collaboration within the clinic; psychological care for patients and care partners; and opportunities for the trainee to build competencies related to assessment, intervention, teams, and consultation. This paper concludes with a discussion of the benefits of NPC as a clinical training rotation for geropsychology trainees, as well as practical considerations for implementation in other clinics.

Programmed Activity Attendance in Assisted Living: An Application of the Theory of Planned Behavior with Additional Health Factors.

Objectives: Programmed activities contribute to the quality of life of assisted living (AL) residents, but attendance rates are often quite low. Using the theory of planned behavior (TPB), this study explores relationships among social cognitive variables, multidimensional health factors, and programmed activity attendance in AL.Methods: In a cross-sectional survey, 185 AL residents (Mage = 83.64, SD = 9.64) self-reported physical and mental health; TPB constructs (i.e., attitudes, subjective norms, behavioral control, and behavioral intention); and the percentage of programmed activities attended in the previous week.Results: Structural modeling showed that TPB was a good fit for the data (χ2/DF = 1.67; CFI = .97; TLI = .96; RMSEA = .06), explaining 82% of variance in behavioral intention and 44% of variance in activity attendance. After adding health factors to the model, only mental health yielded a significant indirect effect on activity attendance.Conclusion: Results provide preliminary support for the viability of TPB as a framework to explain resident activity attendance in AL. Thus, the decision to attend programmed activities in AL may represent a social cognitive process, influenced by mental health.Clinical Implications: Interventions may consider targeting TPB constructs and mental health to increase activity behaviors amongst AL residents.

Behavioral Health Services with Short-Stay Residents in Skilled Nursing Facilities: A Qualitative Study of Clinicians and Administrators.

OBJECTIVES: The perspectives of professionals involved in behavioral health (BH) services with short-stay residents in skilled nursing facilities (SNFs) are rarely captured in the literature. This study examines the real-world experiences of BH clinicians and administrators in post-acute/subacute care units in SNFs. METHODS: This qualitative study used semi-structured interviews with 18 clinicians (e.g., psychologists and social workers) and five administrators (e.g., directors of social services or BH company executives) involved in BH services with short-stay SNF residents. Interviews were recorded, transcribed, and analyzed by two independent coders using conventional thematic content analysis. RESULTS: Three themes emerged from the data: (1) BH needs are high among short-stay residents and families during post-acute care transitions; (2) BH services offer multiple unique opportunities to enhance post-acute/subacute care in SNFs; and (3) barriers to providing optimal BH care exist at multiple levels and require action from BH clinicians and stakeholders. CONCLUSIONS: Variability in clinician roles and barriers to optimized care suggest the need for future research targeting best practices and implementation strategies for BH services with short-stay SNF residents. CLINICAL IMPLICATIONS: Results identified multiple ways in which BH services may enhance resident, family, and staff outcomes, as well as the milieu in SNFs.

Strategies for Implementing Group Mental Health Interventions in a VA Community Living Center.

Objectives: Group mental health interventions are difficult to implement into rehabilitation facilities, but no one has studied the specific barriers. This mixed-methods project systematically examined the implementation of a mental health (MH) group intervention in a VA community living center (CLC) for residents on subacute rehabilitation units, using the Promoting Action on Research Implementation in Health Services (PARIHS) implementation framework.Methods: We implemented a group MH intervention, tracking team referrals, attendance rates, and reasons for declining to participate. We conducted qualitative interviews with attendees.Results: Individual barriers to attendance included acute illness (n = 67, 20%), attitudes toward MH (n = 50; 15%), and perceived busyness (n = 19; 6%). Facility barriers included competing appointments (n = 69; 21%). Interviews demonstrated challenges to implementation, including stigma toward mental health (Theme: Challenges and Supports to Implementation). Attendees found the group relatable, and noted that both positive and negative group dynamics contributed to their experience (Themes: Content Relevance and Group Dynamics).Conclusions: The results provide insight into implementing a group MH treatment into the CLC setting, with implications for the MH care of older adults residing in CLCs.Clinical Implications: 1) Group leaders should consider matching attendees for ability levels (physical or cognitive). 2) At the facility level, leaders may take steps to address stigma toward MH by adopting approaches (e.g., music) or framing MH issues (e.g., use of language) in a way that is approachable. 3) Modifiable barriers at the individual and facility level could be addressed to encourage ease of implementation.

Programmed Activity Offerings and Attendance Patterns in Assisted Living.

The scope of programmed activity offerings and attendance rates for specific activities are not thoroughly captured in the assisted living (AL) literature. The purpose of this study is to report activity offerings and associated attendance rates, as well as relationships between individual factors and activity attendance patterns in a sample of 202 residents of 21 ALs. Sampled communities offered 50 different types of programmed activities. Each AL offered exercise and religious services, most offered BINGO (n = 19, 91%) and socials (n = 18, 86%). BINGO was the most frequently attended activity (n = 83; 47%), followed by religious services (n = 75; 38%), socials (n = 67; 40%), and musical performances (n = 62, 37%). Additional findings provide insight into the features of frequently attended activities, and the relationships between attendance and resident characteristics. The authors conclude with a discussion of implications for service delivery and future research.

Sense of community and its relationship with psychological well-being in assisted living.

Objectives: Sense of community (SOC) is a comprehensive psychological assessment of the relationship between person and place and relates to positive psychological outcomes in community-living adults, but has not been tested in assisted living (AL). This study describes SOC, identifies associated factors, and explores the relationship between SOC and psychological well-being with a sample of AL residents.Method: Participants included 202 residents of 21 ALs. The Brief Sense of Community Scale, a multidimensional theory-based measure, assessed total SOC (Cronbach's α = .87; M = 25.89, SD = 6.08) and dimensions of SOC (i.e. need fulfillment, group membership, influence, and emotional connection).Results: A second-order confirmatory factor analysis supported the multidimensional theoretical framework of SOC with the current sample. While bivariate correlations and multiple regressions varied by dimension, social relationships, physical health, and decisional control in the move to AL consistently yielded positive relationships with SOC factors. In the final step of a hierarchical multiple regression, total SOC significantly related to psychological well-being (F(1, 192) = 7.92, p = .005); although, its contribution was small (3%) when accounting for relevant covariates.Conclusion: Key findings suggest that the most accepted framework of SOC with community-living adults can be applied to the AL setting, but requires additional theoretical and empirical work. Findings also provide preliminary support for the relationship between SOC and psychological well-being. The authors discuss implications for future research and clinical practice, including strategies to promote SOC for AL residents.

Advancing Methodological Rigor for Psychosocial Aspects of Neuropalliative Care Interventions.

Background: Neurological disorders (NDs) have unique biopsychosocial-spiritual features that impact patients and their families. As a result, the subspeciality of neuropalliative care (NPC) emerged within the past decade and has grown exponentially in research and practice. Given the cognitive, emotional, and behavioral changes associated with NDs, psychosocial components (eg, coping skills) of NPC interventions are essential for improving the quality of life for patients and families. However, psychosocial components of NPC interventions warrant more rigorous testing to improve their evidence base and their likelihood of implementation and dissemination. Aim: In this commentary, we provide methodological recommendations with the goal of improving scientific knowledge and rigor for psychosocial components of multicomponent NPC interventions in clinical trials. Results: We emphasize the need for transparent reporting of psychosocial intervention components; using established models of intervention development to guide the development and testing of multicomponent NPC interventions; identifying mechanisms of action for psychosocial outcomes; and choosing psychometrically sound measures for mechanisms and outcomes. Conclusions: Given the importance of psychosocial care to the holistic NPC model, rigorous testing of psychosocial components of NPC interventions is a high priority for clinical investigators to advance the evidence base and practice of NPC.

Family Involvement in the Care of Nursing Home Residents With Dementia: A Scoping Review.

Family members are involved in the lives of older adults with dementia in complex ways. This scoping review synthesizes existing research on family involvement in the care of nursing home residents with advanced dementia. Using the Arksey and O'Malley scoping review framework, electronic searches of PubMed, EBSCO's CINAHL Complete, and APA PsychInfo on the Ovid platform were conducted. Twenty-eight studies met inclusion criteria. Emergent themes and definitions of involvement were obtained through thematic analysis, including: (1) contact (through visitation, calling, or writing letters); (2) engagement in care activities (instrumental/activities of daily living); (3) planning and monitoring care (being aware of health and treatment changes, partnership with care staff, ensuring adequate care, and decision-making); and (4) supporting the resident (advocacy, socioemotional support, and financial support). Moreover, limited psychometrically sound instruments exist to measure family involvement. These limitations stall the progression of research targeting family involvement.

"They really trust us!": Medical Interpreter's Roles and Experiences in an Integrated Primary Care Clinic.

This study describes medical interpreters' experiences with behavioral health (BH) services in a primary care clinic. Focus group data with medical interpreters representing multiple languages was analyzed using hybrid inductive-deductive thematic analysis. Themes related to interpreter roles were: (1) case management, (2) patient-interpreter relationship, and (3) patient-provider liaison. Themes related to barriers and facilitators to interpreter-mediated BH care were: (1) cultural factors, (2) patient-provider interactions, (3) BH-specific considerations, and (4) clinic factors. Results illustrate ways that interpreters directly (e.g., interpreter-mediated services) and indirectly (e.g., relationship building) support care. The interpreter-patient relationship reportedly helped improve patient attitudes and buy-in for BH.

Spilling over at the boiling point: A commentary on the need for dyadic approaches to psychosocial care with older adults and their care-partners in postacute rehabilitation.

PURPOSE/OBJECTIVE: Older adults typically receive rehabilitation services following an acute medical event within the context of declining health. Post-acute rehabilitation often serves as a "boiling point" for health needs and is met with numerous shared emotional stressors related to recovery, long-term care, and end-of-life considerations among older patients and their care-partners-referred to together as a dyad. Psychosocial intervention that targets patients and care-partners separately misses the opportunity to support dyads who typically navigate health-related emotional challenges together. In the context of chronic and serious illness, dyadic interventions (i.e., patient and informal care-partner, together) can successfully reduce emotional distress as well as improve communication and collaborative illness management. However, this approach has yet to be applied to older post-acute rehabilitation patients and their care-partners. RESEARCH METHOD/DESIGN: In this commentary, we outline the need for dyadic psychosocial intervention approaches with older adults and their family care-partners in the context of post-acute rehabilitation. RESULTS: First, we provide evidence for the potential benefits of a dyadic approach to psychosocial care. Next, we review theoretical models as well as clinically relevant confounding factors that can inform dyadic psychosocial case conceptualization and intervention. Finally, we offer a real-world clinical case example that demonstrates the opportunity for dyadic intervention to address common psychosocial challenges seen by psychologists in post-acute rehabilitation settings. CONCLUSIONS/IMPLICATIONS: Our goal is to encourage rehabilitation psychologists to view dyadic intervention as a first-line approach to psychosocial care with the growing population of older adults and their family care-partners in post-acute rehabilitation settings. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Open to interpretation: An integrated primary care behavioral health training approach for treating linguistically diverse patients.

INTRODUCTION: Integrated primary care settings serve an increasingly high volume of linguistically diverse patients. In English language-dominant countries, limited English proficiency (LEP) is associated with disparities in access and quality of behavioral health (BH) care. Interpretive services (IS) aim to address these disparities by assisting in the delivery of clinical care between patients and providers who speak different languages. Yet, there is a need for greater emphasis on the utilization of IS in clinical training for BH professionals (e.g., psychology, social work, counseling, and family therapy). METHOD: In this conceptual article, we describe a BH practicum rotation for predoctoral psychology trainees in a free, student-run integrated primary care clinic that largely serves uninsured adults with LEP. First, we discuss our training model which includes a 90-min didactic lecture on IS for BH and supervised applied clinical experiences (e.g., psychotherapy, warm handoffs, and consultation). Then, we present vignettes prepared by trainees about the challenges and benefits associated with delivering BH care with IS at the predoctoral level of training. RESULTS: From the practicum experience, clinical psychology trainees reported improved knowledge and competencies in utilizing IS as well as generalizable skills for delivering BH care with a focus on multicultural practice. DISCUSSION: We recommend that other integrated primary care BH training sites consider emphasizing training in IS. This article concludes with recommendations for implementation and dissemination of our training model on other sites. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Bio-Experiential Technology to Support Persons With Dementia and Care Partners at Home (TEND): Protocol for an Intervention Development Study.

BACKGROUND: Alzheimer disease and related dementias are debilitating and incurable diseases. Persons with dementia and their informal caregivers (ie, dyads) experience high rates of emotional distress and negative health outcomes. Several barriers prevent dyads from engaging in psychosocial care including cost, transportation, and a lack of treatments that target later stages of dementia and target the dyad together. Technologically informed treatment and serious gaming have been shown to be feasible and effective among persons living with dementia and their care partners. To increase access, there is a need for technologically informed psychosocial interventions which target the dyad, together in the home. OBJECTIVE: This study aims to develop the toolkit for experiential well-being in dementia, a dyadic, "bio-experiential" intervention for persons with dementia and their caregivers. Per our conceptual model, the toolkit for experiential well-being in dementia platform aims to target sustained attention, positive emotions, and active engagement among dyads. In this paper, we outline the protocol and conceptual model for intervention development and partnership with design and development experts. METHODS: We followed the National Institutes of Health (NIH) stage model (stage 1A) and supplemented the model with principles of user-centered design. The first step includes understanding user needs, goals, and strengths. We met this step by engaging in methodology and definition synthesis and conducting focus groups with dementia care providers (N=10) and persons with dementia and caregivers (N=11). Step 2 includes developing and refining the prototype. We will meet this step by engaging dyads in up to 20 iterations of platform ß testing workshops. Step 3 includes observing user interactions with the prototype. We will meet this step by releasing the platform for feasibility testing. RESULTS: Key takeaways from the focus groups include balancing individualization and the dyadic relationship and avoiding confusing stimuli. As of September 2023, we have completed focus groups with providers, persons with dementia, and their caregivers. Additionally, we have conducted 4 iterations of ß testing workshops with dyads. Feedback from focus groups informed the ß testing workshops; data have not yet been formally analyzed and will be reported in future publications. CONCLUSIONS: Technological interventions, particularly "bio-experiential" technology, can be used in dementia care to support emotional health among persons with a diagnosis and caregivers. Here, we outline a collaborative intervention development process of bio-experiential technology through a research, design, and development partnership. Next, we are planning to test the platform's feasibility as well as its impact on clinical outcomes and mechanisms of action. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52799.