Subject(s)
Climate Change/economics , Congresses as Topic/organization & administration , Health Care Sector/legislation & jurisprudence , Hope/ethics , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/virology , Carbon Footprint/statistics & numerical data , Climate Change/statistics & numerical data , Global Warming/prevention & control , Global Warming/statistics & numerical data , Health Care Sector/statistics & numerical data , Hope/physiology , Humans , SARS-CoV-2/genetics , Sustainable Development/legislation & jurisprudence , Waste Disposal, Fluid/legislation & jurisprudence , World Health Organization/organization & administrationABSTRACT
ABSTRACT: This study aimed to explore the levels of resilience and hope among Yazidi women who survived captivity by Islamic State of Iraq and Syria (ISIS) and to examine its relationship with posttraumatic stress disorder (PTSD), generalized anxiety, and depressive symptoms. In this cross-sectional study, 139 formerly enslaved Yazidi women were assessed. The mean scores of resilience and hope were below the suggested cutoff means (M = 2.47, SD = 0.48, R = 1-5) and (M = 31.6, SD = 11.7, R = 8-64), respectively. Sociodemographic variables were not related to resilience and hope, other than those women who stayed in captivity for more than a 3-year period who reported significantly lower levels of hope (M = 28.36, SD = 11.69). Formerly enslaved Yazidi women who display higher levels of PTSD, generalized anxiety, and depression exhibit significantly lower levels of resilience and hope. Resilience and hope are therefore important concepts to explore in traumatized populations.
Subject(s)
Anxiety Disorders/physiopathology , Depressive Disorder/physiopathology , Enslavement , Hope/physiology , Resilience, Psychological/physiology , Stress Disorders, Post-Traumatic/physiopathology , Survivors/psychology , Adolescent , Adult , Armed Conflicts , Cross-Sectional Studies , Female , Humans , Iraq , Middle Aged , Syria , Violence , Young AdultABSTRACT
Efforts have been made to support the academic success and address the retention of low academically performing college students; however, little is known about how these interventions are effective. This study builds upon recent findings that the hope and belongingness of college students in a group-based academic enhancement intervention were important factors in their academic success. Applying person-environment fit theory, this study assessed changes in an individual's hope and belongingness, changes in the group's hope and belongingness, and the interaction between changes in both an individual's hope and belongingness and the group's hope and belongingness (i.e., person-group fit) on the academic outcomes of 145 college students participating in 11 academic enhancement seminars. Results indicated that changes in a student's hope and belongingness were positively associated with changes in their academic self-efficacy, but not their academic performance, as measured by grade point average (GPA). However, the changes in the group's hope and belongingness moderated the relationship between students' changes in hope and belongingness and their academic performance, such that these relationships were stronger when the student fit with their group in regard to their perceived changes in hope and belongingness (i.e., high individual-high group change). This study provides further support for the importance of instilling hope and a sense of belongingness in students within academic enhancement groups, and the complex influence of group-level processes within these interventions. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
Subject(s)
Academic Success , Hope , Peer Group , Students/psychology , Universities/trends , Adolescent , Female , Hope/physiology , Humans , Male , Young AdultABSTRACT
PURPOSE: This study aims to examine the relationship between the level of hope in mothers who have a child with cancer and its related factors in Iran. METHOD: A cross-sectional and descriptive correlational design was used in this study. A demographic questionnaire and the Herth Hope Index (HHI) were administered to a sample of 240 mothers who have a child with cancer to assess level of hope. Mothers were also asked to indicate their highest priority hopes such as view of their supportive resources including financial support, psychosocial support, religiosity and spirituality. Data was analysed using descriptive statistics, Spearman's rho, independent sample t test and one-way ANOVA. RESULTS: The mean HHI score was 35.44 (n = 237). There was a positive correlation between HHI total score and spirituality (r = 0.267, P < 0.001), and psychosocial support (r = 0.281, P < 0.001). No significant differences were found between HHI total score and respondents who saw themselves as a religious person and the family financial support. There was a significant difference in HHI total scores for a mother who has a disabled child (M = 32.92, SD = 2.75; t (235) = 2.00, P = 0.046) and mothers of a child who do not have any disability besides their cancer (M = 35.59, SD = 4.91). No significant differences were found in the HHI total score and different group of the child's diagnoses and the mother's age or/and child's age. CONCLUSION: Mothers who have a child with cancer with better psychosocial and spiritual support showed a higher level of hope. A thorough knowledge of factors associated with hope in mothers caring for children suffering from cancer could provide a means to further advance the support delivered and the available resources given to the parents, especially the mothers.
Subject(s)
Hope/physiology , Neoplasms/psychology , Spirituality , Cross-Sectional Studies , Female , Humans , Iran , Male , MothersABSTRACT
Hopefulness is associated with better health and may be integral for stress adaptation and resilience. Limited research has prospectively examined whether hopefulness protects against physiological dysregulation or does so similarly for U.S. whites, blacks and Hispanics. We examined the association between baseline hopefulness and future allostatic load using data from the Health and Retirement Study (n = 8,486) and assessed differences in this association by race/ethnicity and experiences of discrimination. Four items measured hopefulness and allostatic load was a count of seven biomarkers for which a respondent's measured value was considered high-risk for disease. A dichotomous variable assessed whether respondents experienced at least one major act of discrimination in their lifetime. We used Poisson regression to examine the association between hopefulness and allostatic load and included a multiplicative interaction term to test racial/ethnic differences in this association. Subsequent analyses were stratified by race/ethnicity and tested the interaction between hopefulness and discrimination within each racial/ethnic group. Hopefulness was associated with lower allostatic load scores, but its effects varied significantly by race/ethnicity. Race-stratified analyses suggested that hopefulness was protective among whites and not associated with allostatic load among Hispanics irrespective of experiencing discrimination. Hopefulness was associated with lower allostatic load among blacks reporting discrimination but associated with higher allostatic load among those who did not. Findings suggest that hopefulness plays differing roles for older whites, blacks and Hispanics and, for blacks, its protective effects on physiological dysregulation are intricately tied to their experiences of discrimination.
Subject(s)
Allostasis/physiology , Ethnicity/psychology , Hope/physiology , Black or African American/psychology , Aged , Aged, 80 and over , Biomarkers , Databases, Factual , Female , Health Status Disparities , Hispanic or Latino/psychology , Humans , Male , Middle Aged , Race Factors/trends , Racism/psychology , Racism/trends , Resilience, Psychological , Stress, Psychological/physiopathology , United States , White People/psychologyABSTRACT
Background: There are limited data on suicidal behaviour in obsessive-compulsive disorder (OCD). This study aimed to evaluate several aspects affecting suicidality in OCD patients and determine whether impulsivity or hostility are associated with suicide attempts in this vulnerable group.Methods: Eighty-one patients with OCD were assessed by structured clinical interview for DSM-IV (SCID I), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Suicide Probability Scale (SPS), Barratt impulsivity scale-11 (BIS) and Scale for suicide ideation (SSI).Results: Of the 81 patients, 22 (27%) had suicide ideation, 29 (33%) attempted suicides with OCD and 30 (37%) OCD patients who never experienced suicide ideation nor attempted suicide. Suicide ideation was associated with high hopelessness, higher severity of OCD and the presence of aggressive obsessions. On the other hand, suicide attempts were associated with longer duration of untreated illness, cognitive impulsivity, higher severity of OCD symptoms and the presence of religious obsessions.Conclusion: Higher severity of OCD symptoms is associated with both suicide ideation and attempts. And while hopelessness was related to suicidal thoughts, cognitive impulsivity may have acted as a facilitating factor for suicide attempts. Higher frequency of symptoms like religious/ aggressive obsessions was also associated with suicidality. It is vital that patients with OCD undergo detailed assessment for suicide risk.Key pointsOCD is associated with a high risk for suicidal behaviour.Suicide ideation was associated with high levels of hopelessness, OCD severity, and the presence of aggressive obsessions.Suicide attempts were associated with longer duration of untreated illness, cognitive impulsivity, severity of OCD, and the presence of religious obsessions.
Subject(s)
Aggression/physiology , Hope/physiology , Hostility , Impulsive Behavior/physiology , Obsessive-Compulsive Disorder/physiopathology , Suicidal Ideation , Suicide, Attempted , Adult , Cross-Sectional Studies , Female , Humans , Male , Religion and Psychology , Severity of Illness Index , Time-to-Treatment , Young AdultABSTRACT
OBJECTIVE: The objective of this study was to gain a better understanding of parental hopes and worries before and subsequent experiences two years after their child had undergone epilepsy surgery. METHODS: The parents of 107 children and young people who underwent epilepsy surgery at a single center completed surveys focusing on hopes and concerns before surgery and subsequent experiences at two-year follow-up. Responses were analyzed by thematic analysis. RESULTS: Before surgery, parental hopes focus on not only seizure freedom or reduction but also potential improvements in child development and emotional-behavioral functioning. Worries before surgery include not only potential injury or loss of skills but also a concern that the surgical procedure would not lead to an improvement in the child's seizures. The vast majority of parents experienced positive aspects at the two-year follow-up including seizure freedom or reduction but also perceived improvements in behavior, development, and sleep. This suggests that for many, expectations for the surgery were met. A small number of parents reported negative effects of surgery including loss of skills, worsening/lack of improvement in seizure frequency, or negative impact on development. SIGNIFICANCE: For the majority of parents whose children undergo surgery, expectations are met, and fears are not realized. Knowledge of parental hopes and worries before surgery as well as experiences after the operation is useful for improving pre- and postsurgical counseling.
Subject(s)
Epilepsy/psychology , Epilepsy/surgery , Hope , Parents/psychology , Seizures/psychology , Seizures/surgery , Adolescent , Child , Child, Preschool , Epilepsy/epidemiology , Female , Follow-Up Studies , Hope/physiology , Humans , Infant , Longitudinal Studies , Male , Patient Satisfaction , Surveys and Questionnaires , Sweden/epidemiology , Time Factors , Young AdultABSTRACT
The "Illness Identity" model proposed that self-stigma impacts hope and self-esteem and subsequently leads to a cascade of negative effects on outcomes related to recovery among people diagnosed with severe mental illnesses. The purpose of the present review is to take stock of research support for the model. The citation index SCOPUS was reviewed for all papers published in peer-reviewed journals in English between 2010 and 2019 citing one of the initial 3 articles discussing the model: 111 studies met inclusion criteria and were reviewed. The most frequently tested, and supported, aspects of the model were relationships between self-stigma and self-esteem, hope, psychiatric symptoms and social relationships. Least frequently studied areas were relationships with suicide, avoidant coping, treatment adherence and vocational functioning, although they were supported in the majority of studies. The "insight paradox" was also tested in a relatively small number of studies, with mixed results. Findings were robust to geographic location of study, method, and subpopulation studied. Findings indicate that a large body of research has tested, and largely supported, the various components of the Illness Identity model, although some components need further investigation and there is a need for more comprehensive tests of the model.
Subject(s)
Mental Disorders/psychology , Recovery of Function , Self Concept , Severity of Illness Index , Social Stigma , Cross-Sectional Studies , Hope/physiology , Humans , Mental Disorders/diagnosis , Prospective Studies , Recovery of Function/physiologyABSTRACT
Although hope and forgiveness have been both negatively correlated with depression, actual relationships between all three variables have never been investigated. The aim of the study was to examine a theoretical model in which forgiveness mediates the relationship between basic hope and depressive symptoms. The sample was composed of 77 psychotherapy outpatients. Polish adaptations of the Basic Hope Inventory, the Beck Depression Inventory, and the Heartland Forgiveness Scale were used. Negative and positive aspects of dispositional forgiveness of self, others, and situations beyond anyone's control were applied. Results indicated that the general level of forgiveness, as well as overcoming unforgiveness, fully mediated the relationship between basic hope and depression symptoms, while positive dimension of forgiveness partially mediated the links between the variables. The findings demonstrate that the tendency to forgive might be a mechanism via which basic hope reduces odds of depression.
Subject(s)
Depression/physiopathology , Forgiveness/physiology , Hope/physiology , Adult , Aged , Female , Humans , Male , Middle Aged , Models, Psychological , Young AdultSubject(s)
Bereavement , Decision Making , Hope/physiology , Parent-Child Relations , Parents/psychology , Attitude to Death , Child , Decision Making/physiology , Female , Humans , MaleABSTRACT
The aim of the study was to examine correlations among maladaptive perfectionism, hope, and anxiety and the moderating role of hope in the relationship between maladaptive perfectionism and anxiety among early adolescents. The sample of the study consisted of 639 early adolescents (354 female/285 male; Meanage = 12.8, SDage = .65, range: 11-14). In line with this purpose, the cross-sectional model was conducted. The findings of the study showed that there were significant correlations among maladaptive perfectionism, hope, and anxiety. Moreover, the findings found that hope moderated the relationship between maladaptive perfectionism and anxiety. More specifically, the findings suggested that among early adolescents with lower hope, the relationship between maladaptive perfectionism and anxiety was stronger than those with higher hope.
Subject(s)
Adaptation, Psychological/physiology , Anxiety/physiopathology , Hope/physiology , Perfectionism , Adolescent , Child , Cross-Sectional Studies , Female , Humans , MaleABSTRACT
Hope is a trait that represents the capacity to identify strategies or pathways to achieve goals and the motivation or agency to effectively pursue those pathways. Hope has been demonstrated to be a robust source of resilience to anxiety and stress and there is limited evidence that, as has been suggested for decades, hope may function as a core process or transdiagnostic mechanism of change in psychotherapy. The current study examined the role of hope in predicting recovery in a clinical trial in which 223 individuals with 1 of 4 anxiety disorders were randomized to transdiagnostic cognitive behavior therapy (CBT), disorder-specific CBT, or a waitlist controlled condition. Effect size results indicated moderate to large intraindividual increases in hope, that changes in hope were consistent across the five CBT treatment protocols, that changes in hope were significantly greater in CBT relative to waitlist, and that changes in hope began early in treatment. Results of growth curve analyses indicated that CBT was a robust predictor of trajectories of change in hope compared to waitlist, and that changes in hope predicted changes in both self-reported and clinician-rated anxiety. Finally, a statistically significant indirect effect was found indicating that the effects of treatment on changes in anxiety were mediated by treatment effects on hope. Together, these results suggest that hope may be a promising transdiagnostic mechanism of change that is relevant across anxiety disorders and treatment protocols.
Subject(s)
Anxiety Disorders/diagnosis , Anxiety Disorders/therapy , Cognitive Behavioral Therapy/methods , Hope/physiology , Self Report , Adolescent , Adult , Aged , Anxiety Disorders/psychology , Clinical Protocols , Female , Humans , Male , Middle Aged , Motivation/physiology , Treatment Outcome , Young AdultABSTRACT
PURPOSE: Cross-sectional research suggests that thinking about multiple ways to reach goals (hope pathways) and the belief that one can reach them (hope agency) may be adaptive for lung cancer patients. We examined the between-person and within-person associations among aspects of hope agency and pathways thinking, daily fatigue, pain, and functional concerns (e.g., sense of independence, usefulness) among lung cancer patients during active treatment. METHODS: Data from a daily diary study were used to examine relations among hope agency, hope pathways, fatigue, pain, and functional concern in 50 patients with advanced lung cancer. Participants were accrued from one outpatient cancer center and completed the study between 2014 and 2015. RESULTS: Adjusting for covariates and the previous day's symptoms or concern, patients who engaged in higher pathways thinking reported lower daily symptoms, whereas those who engaged in higher agency thinking reported less functional concern. Within-person increases in pathways thinking were associated with less daily fatigue, pain, and functional concern; within-person increases in agency thinking were associated with less daily fatigue and pain. Models examining symptoms and concerns as predictors of hope suggested within-person increases in functional concern and fatigue and pain were related to lower agency and pathways thinking the same day. Patients with higher fatigue and pain did not report lower agency or pathways thinking, but patients with more functional concern did. CONCLUSIONS: Increases in hope pathways thinking may be associated with lower symptoms and better functioning in lung cancer patients. This suggests that it is important to determine the efficacy of interventions that emphasize the pathways the component of hope.
Subject(s)
Fatigue/etiology , Hope/physiology , Lung Neoplasms/complications , Pain/etiology , Cross-Sectional Studies , Female , Humans , MaleABSTRACT
Extracurricular groups can promote healthy development, yet the literature has given limited attention to indirect associations between extracurricular involvement and mental health or to sexual and gender minority youth. Among 580 youth (Mage = 15.59, range = 10-20 years) and adult advisors in 38 Gender-Sexuality Alliances (GSAs), multilevel structural equation models showed that greater engagement in GSAs over the school year predicted increased perceived peer validation, self-efficacy to promote social justice, and hope (baseline adjusted). Through increased hope, greater engagement indirectly predicted reduced depressive and anxiety symptoms at the year's end (baseline adjusted). GSAs whose members had more mental health discussions and more meetings reported reduced mental health concerns. Findings suggest how groups addressing issues of equity and justice improve members' health.
Subject(s)
Empowerment , Mental Disorders/prevention & control , Psychosocial Support Systems , Sexual and Gender Minorities/psychology , Social Participation , Adolescent , Adult , Child , Female , Hope/physiology , Humans , Male , Massachusetts , Mental Disorders/epidemiology , Mental Disorders/etiology , Mental Disorders/psychology , Mental Health , Neurodevelopmental Disorders/epidemiology , Neurodevelopmental Disorders/etiology , Neurodevelopmental Disorders/prevention & control , Neurodevelopmental Disorders/psychology , Peer Group , Risk Factors , School Mental Health Services/organization & administration , School Mental Health Services/supply & distribution , Self Efficacy , Social Environment , Social Justice/psychology , Social Participation/psychology , Surveys and Questionnaires , Young AdultABSTRACT
Scholars have proposed that immigrant optimism explains why some immigrant students outperform their United States-born peers academically. Yet, immigrant optimism has not been directly measured. This study aims to test the immigrant optimism hypothesis by operationalizing it using the Children's Hope Scale. Using structural equation modeling, the author examined the associations between hope, immigrant generation, citizenship status, and academic outcomes among a sample of 2,369 Latino 14- to 17-year-old students. Though no difference by immigrant generation was found, undocumented students were more hopeful than their documented peers. This finding suggests that the documentation status has an indirect relative effect on academic outcomes via hope. This article reexamines the immigrant optimism as a resource that could be fostered among Latino youth, regardless of immigrant status.
Subject(s)
Emigrants and Immigrants/psychology , Hispanic or Latino , Hope/physiology , Optimism , Students , Adolescent , Educational Status , Emigrants and Immigrants/education , Emigrants and Immigrants/statistics & numerical data , Female , Hispanic or Latino/education , Hispanic or Latino/psychology , Hispanic or Latino/statistics & numerical data , Humans , Latent Class Analysis , Male , Optimism/psychology , Students/psychology , Students/statistics & numerical data , United States/epidemiology , Universities/statistics & numerical dataABSTRACT
BACKGROUND: Older adults represent the segment of population most exposed to the risk of suicide nearly everywhere in the world. Previous studies showed that hopelessness was an important risk factor for suicide. AIMS: This study aimed to evaluate the reliability and validity of the four-item Beck Hopelessness Scale (BHS-4) in psychological autopsy study among Chinese rural elderly. METHOD: Two-stage stratified cluster sampling method was used to select research sites. Using case-control psychological autopsy study, face-to-face interviews were conducted to collected information. RESULTS: A total of 242 elderly suicide deaths and 242 matched living comparisons were investigated, including 135 males and 107 females for each group. Intraclass Correlation Coefficients (ICC) of the controls were 0.682-0.713. The median score of BHS-4 among suicides was significantly higher than that among controls. The corrected correlation coefficient between items and total score were 0.184-0.723. Cronbach's Alphas coefficient was 0.834. Only one common factor was precipitated by exploratory factor analysis and the cumulative variance contribution rates were 59.558% for suicides and 52.722% for living controls. The correlation coefficient between hopelessness and depression were 0.481 among suicide death and 0.617 among living controls. CONCLUSION: The information provided by the informants through psychological autopsy method had high reliability to reflect the actual situation of suicides and controls. BHS-4 has good reliability and validity among Chinese rural elderly suicides. It is suitable for psychological autopsy study among Chinese rural elderly.
Subject(s)
Asian People/psychology , Autopsy , Depression/psychology , Depressive Disorder/psychology , Hope/physiology , Psychiatric Status Rating Scales/standards , Psychometrics/instrumentation , Rural Population , Suicide/psychology , Aged , Asian People/statistics & numerical data , China , Depression/diagnosis , Depressive Disorder/diagnosis , Female , Humans , Male , Middle Aged , Reproducibility of ResultsABSTRACT
Objectives: The current study aims to examine the reliability and validity of the Adult Hope Scale among older adults with and without cognitive impairment who were recently admitted to a nursing home.Methods: Sixty-four recently admitted nursing home residents, 32 of whom had cognitive impairment, were administered the Adult Hope Scale and measures of concurrent and divergent validity.Results: In this sample, the Adult Hope Scale demonstrated good to excellent reliability. The Adult Hope Scale also correlated as expected with measures of concurrent and divergent validity, thus supporting the validity of the scale to measure hope in older adults despite level of cognitive functioning.Conclusions: This study shows that the Adult Hope Scale is a reliable and valid measure of hope in this sample of older adults with and without cognitive impairment who were recently admitted to a nursing home. Given the small sample size, additional research on the psychometric properties of the utility of the Adult Hope Scale in older adults with and without cognitive impairment is warranted.Clinical Implications: These preliminary findings allow future researchers and clinicians to consider administration of the Adult Hope Scale to individuals with and without cognitive impairment living in long-term care facilities. Gathering additional data on the psychometrics of this measure will enable new directions in research involving self-report measures for older adults with cognitive impairment, and in the development of interventions involving hope to improve physical and mental health in long-term care residents.
Subject(s)
Cognition/physiology , Cognitive Dysfunction/psychology , Hope/physiology , Long-Term Care/psychology , Nursing Homes/statistics & numerical data , Aged , Aged, 80 and over , Cognitive Dysfunction/diagnosis , Cognitive Dysfunction/epidemiology , Cognitive Dysfunction/ethnology , Female , Humans , Long-Term Care/statistics & numerical data , Male , Middle Aged , Prospective Studies , Psychometrics/methods , Quality of Life , Reproducibility of Results , Self Report/statistics & numerical dataABSTRACT
Suicide constitutes a public health problem that has a significant economic, social and psychological impact on a global scale. Recently, the American Psychological Association has indicated that suicide prevention should be a public health priority. Suicidal ideation appears as a key variable in suicide prevention. The objective of this research was to verify the adjustment of an explanatory model for suicidal ideation, which considers the effects of cognitive emotion regulation strategies, affectivity and hopelessness. An open mode on-line sample of 2,166 Argentine participants was used and a path analysis was carried out. The results make it possible to conclude that the model presents an optimal fit (χ2 = .10, p = .75, CFI = .99, RMSEA = .01) and predicts 42% of suicidal thoughts. The model proves to be invariant based on age and gender. In conclusion, there is an importance of reducing the use of automatic strategies, such as repetitive negative thoughts of ruminative type, and increasing the use of more controlled strategies, such as reinterpretation or planning.
Subject(s)
Affect/physiology , Emotional Regulation/physiology , Hope/physiology , Models, Psychological , Suicidal Ideation , Adolescent , Adult , Aged , Argentina , Female , Humans , Male , Middle Aged , Young AdultABSTRACT
INTRODUCTION: Adolescents can be prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression following disasters. School teachers can provide timely psycho-social support that could instill hope and improve mental health among adolescents in a post-earthquake situation in a low-resource setting. This study examined the effect of training for school teachers on psycho-social support on adolescents' mental health and hope in an earthquake affected district in Nepal. METHODS: This cluster randomized controlled trial was conducted in 15 schools in Dhading, a severely affected district by the 2015 earthquake in Nepal. The schools were randomized, as a result, 8 were in the intervention group and 7 in the control group. A total of 1,220 adolescents were recruited at baseline of which 605 adolescents belonged to intervention group and 615 to control group. The follow-up rate at 6 months was 83%. This trial was registered with Clinicaltrials.gov with registration number NCT03387007. RESULTS: The intervention did not show significant effects for PTSD symptoms (Intervention*time, ß = 0.33, p = 0.536), depression symptoms (Intervention*time, ß = 0.30, p = 0.249), and hope (Intervention*time, ß = -0.23, p = 0.588), among the adolescents at 6 months follow-up. CONCLUSION: The intervention did not improve mental health symptoms and hope among adolescents at 6 months follow-up. More focused and longer training could be necessary to address mental health among adolescents affected by earthquake. Additionally, longer follow-up could be necessary to assess the changes taking place over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03387007.