BACKGROUND: Depression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology. OBJECTIVE: We aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations. METHODS: This 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition. RESULTS: This RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023. CONCLUSIONS: This trial will be the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of an RCT using an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45100.
BACKGROUND: Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. OBJECTIVE: The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. METHODS: A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice-all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. RESULTS: Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. CONCLUSIONS: Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. TRIAL REGISTRATION: ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17721.
Growing evidence links psychological well-being (e.g., optimism) with superior cardiac health, but there remains a critical scientific gap as we do not know whether (or how) interventions to cultivate emotional well-being may reduce cardiac risk. Hispanics/Latinos in the U.S. have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared to peers of European ancestry, and represent a population in need of new and innovative therapeutic approaches. This paper details the "¡Alégrate!" study, a cluster-randomized Phase II trial testing efficacy in improving BP of a culturally tailored positive psychological intervention designed to boost emotional well-being in Hispanics/Latinos with hypertension. A total of 126 Hispanics/Latinos aged ≥18 years, fluent in English or Spanish, and with elevated sitting BP (≥140/90â¯mmHg) will participate in one of two trial arms: (1) a positive psychological intervention, or (2) a wait-list control condition. The "¡Alégrate!" group-based intervention consists of 8 weekly 90-120-min sessions delivered in-person by a psychologist/social worker. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation, among others. The primary outcome is improvement in BP, both sitting values and 24-h ambulatory readings, as measured at baseline and 8- and 12-weeks post-baseline. Secondary outcomes include emotional well-being, engagement in healthful behaviors, and circulating levels of inflammatory markers. We hypothesize that BP control, psychological well-being, healthful behaviors, and chronic inflammation will be significantly better in the "¡Alégrate!" arm at follow up compared to the wait-list control group.
Although increasing emotional well-being has been proposed as a potential pathway to drive cardiac health, emotional well-being interventions for people with cardiac risk are underdeveloped, particularly among Hispanic/Latino adults. Our objective was to pilot a well-being intervention drawing on positive psychology concepts to determine feasibility and acceptability in Hispanics/Latinos at risk for cardiovascular disease (CVD). We developed a Spanish-language positive psychological intervention, with cultural tailoring informed by formative qualitative work, to promote emotional well-being and its antecedents in Hispanics/Latinos. Hispanic/Latino adults (n = 19) self-reporting two or more CVD risk factors were enrolled in our single-arm 8-week pilot trial. The group intervention consisted of 8 weekly 90-min sessions delivered by a bilingual licensed clinical social worker. Mean age was 54.1 years, 68.8% were female, and 50% had ≤eighth-grade education. Eleven of 19 Hispanic/Latino adults completed the 8-week program for a 57.89% retention rate, with a majority of factors leading to dropout unrelated to program content or mode of delivery. Most participants felt satisfied overall with each session (97.1%). Largest increases relative to baseline after receiving the intervention were found in engagement in happiness-inducing behaviors (e.g., meditation), emotional vitality, and subjective happiness using metrics of reliable change and effect sizes. This single-arm trial documented adequate feasibility and acceptability, although strategies to increase retention are warranted. Future studies should test our intervention using a randomized trial design with a larger sample size and inclusion of biomarkers (e.g., C-reactive protein) to document impact of our intervention on cardiac-related health.
Cardiovascular Diseases/ethnology , Cardiovascular Diseases/prevention & control , Culturally Competent Care/methods , Patient Acceptance of Health Care/ethnology , Patient Satisfaction , Program Development , Program Evaluation , Psychotherapy/methods , Feasibility Studies , Female , Hispanic or Latino , Humans , Male , Middle Aged , Risk , Social Workers
OBJECTIVE: We conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV. METHOD: One-hundred and fifty-nine participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually delivered positive affect skills intervention or an attention-matched control condition. RESULTS: For the primary outcome of past-day positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12, d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months postdiagnosis compared with an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006, d = -.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048, d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes. CONCLUSIONS: This comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. (PsycINFO Database Record
Counseling , HIV Infections/psychology , HIV Seropositivity/psychology , Health Behavior , Mental Health , Adult , Affect , Emotions , Female , HIV Infections/diagnosis , HIV Seropositivity/diagnosis , Humans , Male , Middle Aged
Major theories informing conceptions of psychological well-being draw heavily from Western-centric perspectives, which often neglect culturally bound frameworks. We investigated how U.S. Hispanics/Latinos conceptualize well-being, how psychosocial and behavioral aspects may increase well-being, and how psychosocial stressors may impact positive emotional states. Spanish-speaking Hispanic/Latino adults were recruited from a church in an urban city in the U.S. and invited to participate in focus groups. Two groups of women (n=19) and one group of men (n=8) participated. The importance of harmonious social relationships emerged as a theme with the central family unit as the fundamental force influencing long-lasting emotional well-being. Additional correlates of well-being included: faith/religiosity; physical health; self-love and -esteem; effective/open communication with family and friends; and financial security. Programs aimed at increasing well-being may need to be adapted before administration in Hispanics/Latinos to include a heightened focus on interpersonal factors. Delivery in religious institutions may also be particularly beneficial.
