Mindfulness-Based Stress Reduction for Symptom Management in Older Individuals with HIV-Associated Neurocognitive Disorder.

The growing number of people aging with HIV represents a group vulnerable to the symptom burdens of HIV-associated neurocognitive disorder (HAND). Among younger groups, Mindfulness-Based Stress Reduction (MBSR) has been shown to help people living with HIV manage HIV-related and other life stress, and although there is some theoretical and empirical evidence that it may be effective among those with cognitive deficits, the approach has not been studied in older populations with HAND. Participants (n = 180) 55 years or older with HIV and cognitive impairment were randomly assigned to either an 8-week MBSR arm or a waitlist control. We assessed the impact of MBSR compared to a waitlist control on psychological outcomes [stress, anxiety, depression, and quality of life (QOL)] and cognitive metrics (e.g., speed of information processing, working memory, attention, impulsivity) measured at baseline, immediately post intervention (8 weeks) and one month later (16 weeks). Intent to treat analyses showed significant improvement in the MBSR group compared to control on symptoms of depression from baseline to 8 weeks, however, the difference was not sustained at 16 weeks. The MBSR group also showed improvement in perceived QOL from baseline to 16 weeks compared to the waitlist control group. Cognitive performance did not differ between the two treatment arms. MBSR shows promise as a tool to help alleviate the symptom burden of depression and low QOL in older individuals living with HAND and future work should address methods to better sustain the beneficial impact on depression and QOL.

Randomized controlled trial of a positive emotion regulation intervention to reduce stress in family caregivers of individuals with Alzheimer's disease: protocol and design for the LEAF 2.0 study.

BACKGROUND: Caring for a loved one with Alzheimer's disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer's disease. METHODS: This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient's dementia severity moderates the effects of the intervention. DISCUSSION: If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer's disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT03610698.

Qualitative similarities and distinctions between participants' experiences with a yoga intervention and an attention control.

PURPOSE: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer. METHODS: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory. RESULTS: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST. CONCLUSIONS: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious.

Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial.

BACKGROUND: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another. OBJECTIVE: The aim of our study is to test whether 3 enhancements-facilitator contact (FC), an online discussion board, and virtual badges (VB)-alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence. METHODS: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions-the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed. RESULTS: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline. CONCLUSIONS: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755.

Yoga for symptom management in oncology: A review of the evidence base and future directions for research.

Because yoga is increasingly recognized as a complementary approach to cancer symptom management, patients/survivors and providers need to understand its potential benefits and limitations both during and after treatment. The authors reviewed randomized controlled trials (RCTs) of yoga conducted at these points in the cancer continuum (N = 29; n = 13 during treatment, n = 12 post-treatment, and n = 4 with mixed samples). Findings both during and after treatment demonstrated the efficacy of yoga to improve overall quality of life (QOL), with improvement in subdomains of QOL varying across studies. Fatigue was the most commonly measured outcome, and most RCTs conducted during or after cancer treatment reported improvements in fatigue. Results also suggested that yoga can improve stress/distress during treatment and post-treatment disturbances in sleep and cognition. Several RCTs provided evidence that yoga may improve biomarkers of stress, inflammation, and immune function. Outcomes with limited or mixed findings (eg, anxiety, depression, pain, cancer-specific symptoms, such as lymphedema) and positive psychological outcomes (such as benefit-finding and life satisfaction) warrant further study. Important future directions for yoga research in oncology include: enrolling participants with cancer types other than breast, standardizing self-report assessments, increasing the use of active control groups and objective measures, and addressing the heterogeneity of yoga interventions, which vary in type, key components (movement, meditation, breathing), dose, and delivery mode.

Review of yoga therapy during cancer treatment.

PURPOSE: Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. METHODS: Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. RESULTS: Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. CONCLUSIONS: Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

Treatment decisional regret among men with prostate cancer: Racial differences and influential factors in the North Carolina Health Access and Prostate Cancer Treatment Project (HCaP-NC).

BACKGROUND: It has been demonstrated that treatment decisional regret affects quality of life in patients with prostate cancer (CaP); however, there are limited studies that identify factors associated with treatment decisional regret, particularly within a racially diverse patient population that has extended follow-up. METHODS: Logistic regression analysis was used to determine associations between decisional regret and potential predictors in a population-based cohort of 348 African American men and 446 Caucasian American men approximately 3 years after CaP diagnosis. RESULTS: Of 794 research participants, 12% experienced treatment decisional regret. Decisional regret was associated with androgen-deprivation therapy (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.1-4.0), recent urinary bother (OR, 3.4; 95% CI, 1.6-7.3), satisfaction with understanding potential treatment side effects (very unsatisfied: OR, 13.3; 95% CI, 5.5-32.2; somewhat unsatisfied: OR, 5.0; 95% CI, 2.3-11.2; neutral: OR, 3.8; 95% CI, 1.9-7.6), and CaP treatment effect on the spousal relationship (very affected: OR, 3.9; 95% CI, 2.0-7.6; somewhat affected: OR, 3.1; 95% CI, 1.4-7.3; neutral: OR, 2.4; 95% CI, 1.9-7.6). Younger African Americans were more likely to experience regret than older African Americans (OR, 3.0; 95% CI, 1.1-8.1), and older African Americans were less likely to experience regret than older Caucasian Americans (OR, 0.2; 95% CI, 0.1-0.7). CONCLUSIONS: Treatment decisional regret remains an important issue in CaP survivors beyond initial treatment. Potential interventions should involve younger African Americans and patient spouses. Increased regret may reflect the unexpected influence of treatment side effects on the patient's everyday life; helping the patient relate potential side effects to his individual situation could improve patient satisfaction.

Trajectories of Posttraumatic Growth and Associated Characteristics in Women with Breast Cancer.

BACKGROUND: Cancer survivors may experience posttraumatic growth (PTG), positive psychological changes resulting from highly stressful events; however, the longitudinal course of PTG is poorly understood. PURPOSE: The purpose of the present study was to determine trajectories of PTG in breast cancer survivors and associated characteristics. METHODS: Women (N = 653) participating in a longitudinal observational study completed questionnaires within 8 months of breast cancer diagnosis and 6, 12, and 18 months later. Group-based modeling identified PTG trajectories. Chi-square tests and ANOVA detected group differences in demographic, medical, and psychosocial variables. RESULTS: Six trajectory groups emerged. Three were stable at different levels of PTG, two increased modestly, and one increased substantially over time. Trajectory groups differed by age, race, receipt of chemotherapy, illness intrusiveness, depressive symptoms, active-adaptive coping, and social support. CONCLUSIONS: This first examination of PTG trajectories in US cancer survivors elucidates heterogeneity in longitudinal patterns of PTG. Future research should determine whether other samples exhibit similar trajectories and whether various PTG trajectories predict mental and physical health outcomes.

A Positive Psychology Intervention for Caregivers of Hematopoietic Stem Cell Transplantation Survivors (PATH-C): Initial Testing and Single-Arm Pilot Trial.

Caregivers of patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) play a crucial role in supporting their loved ones through physical, emotional, and practical challenges. This role has been associated with high levels of psychological distress and low levels of positive psychological well-being (PPWB). Positive psychology interventions for caregivers in other disease groups (eg, breast cancer) have been associated with improved outcomes. However, positive psychology interventions that specifically address HSCT caregivers' psychological needs are currently lacking. The goal of this single-arm open-pilot trial was to determine the feasibility and acceptability of the Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH) intervention for HSCT Caregivers to identify caregiver preferences to tailor PATH for HSCT caregivers. Adult caregivers of HSCT recipients were eligible for PATH during the HSCT recipient's first 100 d post-transplant. We defined, a priori, feasibility as >60% of participants who start the intervention completing ≥6/9 intervention sessions and acceptability as weekly ratings of ease and utility of the PP exercises ≥7/10 on a 10-point Likert Scale (0 = very difficult/not helpful; 10 = very easy/very helpful). We conducted semistructured qualitative exit interviews (n = 15) to explore HSCT caregivers' perception of PATH's content, benefits of PATH, as well as facilitators and barriers to engaging with the intervention. Transcribed interviews were analyzed using framework-guided rapid analysis by 2 coders. The intervention was feasible with 83% (15/18) of caregivers who started the intervention completing ≥6/9 intervention sessions. Among caregivers who completed ≥6/9 intervention sessions, ratings of ease (mean = 8.1; 95% CI: 7.4, 8.7) and utility (mean = 8.3; 95% CI: 7.8, 8.9) also exceeded our a priori threshold of ≥7/10. Caregivers identified benefits of PATH, including identifying and responding to emotions, dedicating time to self-care, and cultivating important relationships. Sociodemographic factors (eg, being retired) and the manualized structure of PATH were cited as facilitators to intervention engagement. Barriers to PATH engagement included lack of time and competing caregiving responsibilities. Caregivers preferred remote intervention delivery within the first 100 d post HSCT. This is the first study to show a 9-wk, phone-delivered positive psychology intervention is feasible in caregivers of allogeneic HSCT recipients. Our findings also underscore the specific preferences of this population for positive psychology interventions. Larger studies are warranted to establish the efficacy of these interventions in addressing persistent unmet psychological needs for HSCT caregivers.

Feasibility, acceptability, and efficacy of a positive emotion regulation intervention to promote resilience for healthcare workers during the COVID-19 pandemic: A randomized controlled trial.

INTRODUCTION: Burnout poses a substantial, ongoing threat to healthcare worker (HCW) wellbeing and to the delivery of safe, quality healthcare. While systemic and organization-level changes in healthcare are critically important, HCWs also need individual-level skills to promote resilience. The objective of this trial is to test feasibility, acceptability, and efficacy of PARK, an online self-guided positive affect regulation intervention, in a sample of healthcare workers during the COVID-19 pandemic. DESIGN AND METHODS: In the context of the unprecedented rise in burnout during the COVID-19 pandemic, we conducted a randomized waitlist-controlled trial of the Positive Affect Regulation sKills (PARK) program-a five-week, online, self-guided coping skills intervention nested within an ongoing cohort of HCWs. N = 554 healthcare workers were randomly assigned to receive the intervention immediately or to receive the intervention after approximately 12 weeks. Outcomes included change in burnout, emotional wellbeing (positive affect, meaning and purpose, depression, anxiety) and sleep over approximately 12 weeks. Analyses included mixed-effects linear regression models comparing change over time in outcomes between intervention and control conditions. RESULTS: One third (n = 554) of the participants in the cohort of HCWs consented to participate and enrolled in PARK in April 2022. Compared to those who did not enroll, participants in the trial reported higher burnout, poorer emotional wellbeing, and poorer sleep at baseline (April, 2022; all ps < .05). Intent-to-treat analyses showed that participants randomly assigned to the intervention immediately (PARK-Now) improved significantly on anxiety (within-group change on PROMIS T-score = -0.63; p = .003) whereas those in the waitlist (PARK-Later) did not (within group T-score change 0.04, p = 0.90). The between-group difference in change, however, was not statistically significant (B = -0.67 p = 0.10). None of the other wellbeing outcomes changed significantly in the intervention group compared to the waitlist. Additional as-treated analyses indicated that those participants who completed all 5 of the weekly online lessons (N = 52; 9.4%) improved significantly more on the primary outcome of positive affect compared to those who enrolled in PARK but completed zero lessons (n = 237; 42.8%; B = 2.85; p = .0001). CONCLUSIONS: Online self-guided coping skills interventions like PARK can be effective in targeted samples and future work will focus on adaptations to increase engagement and tailor PARK for HCWs who could most benefit.

Exploring Retention, Usage, and Efficacy of Web-Based Delivery of Positive Emotion Regulation Skills During the COVID-19 Pandemic.

COVID-19 prompted distress and increased reliance on digital mental health interventions, which previously demonstrated low rates of retention and adherence. This single-arm trial evaluated whether self-guided, web-based, positive affect regulation skills (PARK) were engaging and associated with changes in well-being during the pandemic. Over 6 weeks, PARK delivers brief lessons and practices in skills designed to increase positive emotions: noticing positive events, savoring, gratitude, mindfulness, positive reappraisal, personal strengths, and self-compassion. Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive tests of anxiety, depression, social isolation, positive affect, and meaning and purpose were administered at baseline, post-intervention, and 6 months after baseline. Retention and usage of PARK were measured by the web-based assessment and intervention platforms. The sample (n = 616) was predominantly female, non-Hispanic, white, and well-educated. Of those who completed baseline, only 42% completed a follow-up assessment; 30% never logged into PARK. Among those who did, 86% used at least one skill, but only 14% completed PARK. Across retention and usage metrics, older age predicted more engagement. In multivariable models, people of color and people with greater baseline anxiety were more likely to complete PARK. All well-being indicators improved over time, with greater improvements in anxiety and social isolation among participants who accessed at least one PARK skill compared to those who did not. Retention and usage rates mirrored pre-pandemic trends, but within this select sample, predictors of engagement differed from prior research. Findings underscore the need for additional efforts to ensure equitable access to digital mental health interventions and research. Trials registration: NCT04367922.

Feasibility, Acceptability, and Preliminary Efficacy of a Positive Affect Skills Intervention for Adults With Fibromyalgia.

Background and Objectives: To examine the feasibility, acceptability, and preliminary efficacy of a positive affect skills intervention for middle-aged and older adults with fibromyalgia syndrome (FMS). Research Design and Methods: Ninety-five participants with FMS aged 50 and older (94% female) were randomized to 1 of 2 conditions: (a) Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR; n = 49) or (b) emotion reporting/control (n = 46). LARKSPUR included 5 weeks of skill training that targeted 8 skills to help foster positive affect, including (a) noticing positive events, (b) savoring positive events, (c) identifying personal strengths, (d) behavioral activation to set and work toward attainable goals, (e) mindfulness, (f) positive reappraisal, (g) gratitude, and (h) acts of kindness. Outcome data were collected via online surveys at baseline, postintervention, and 1-month follow-up. Results: Completion rates (88%) and satisfaction ratings (10-point scale) were high (LARKSPUR: M = 9.14, standard deviation (SD) = 1.49; control: M = 8.59, SD = 1.97). Improvements were greater in LARKSPUR participants compared with control participants on measures of positive affect (Cohen's d = 0.19 [0.15, 0.24]), negative affect (Cohen's d = -0.07 [-0.11, -0.02]), and pain catastrophizing (Cohen's d = -0.14 [-0.23, -0.05]). Improvements in positive affect (Cohen's d = 0.17 [0.13, 0.22]) and negative affect (Cohen's d = -0.11 [-0.15, -0.06]) were maintained at 1-month follow-up. Dose-response analyses indicated that intervention engagement significantly predicted pre-to-post and post-to-follow-up reductions in pain catastrophizing. Discussion and Implications: The current preliminary findings add to existing literature and highlight the specific potential of internet-delivered positive affect skills programs for adults with FMS. Clinical Trial Registration: NCT04869345.

Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline.

PURPOSE: To provide evidence-based recommendations to health care providers on integrative approaches to managing anxiety and depression symptoms in adults living with cancer. METHODS: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, methodology, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2023. Outcomes of interest included anxiety or depression symptoms as measured by validated psychometric tools, and adverse events. Expert panel members used this evidence and informal consensus with the Guidelines into Decision Support methodology to develop evidence-based guideline recommendations. RESULTS: The literature search identified 110 relevant studies (30 systematic reviews and 80 randomized controlled trials) to inform the evidence base for this guideline. RECOMMENDATIONS: Recommendations were made for mindfulness-based interventions (MBIs), yoga, relaxation, music therapy, reflexology, and aromatherapy (using inhalation) for treating symptoms of anxiety during active treatment; and MBIs, yoga, acupuncture, tai chi and/or qigong, and reflexology for treating anxiety symptoms after cancer treatment. For depression symptoms, MBIs, yoga, music therapy, relaxation, and reflexology were recommended during treatment, and MBIs, yoga, and tai chi and/or qigong were recommended post-treatment. DISCUSSION: Issues of patient-health care provider communication, health disparities, comorbid medical conditions, cost implications, guideline implementation, provider training and credentialing, and quality assurance of natural health products are discussed. While several approaches such as MBIs and yoga appear effective, limitations of the evidence base including assessment of risk of bias, nonstandardization of therapies, lack of diversity in study samples, and lack of active control conditions as well as future research directions are discussed.Additional information is available at www.asco.org/survivorship-guidelines.

Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples.

BACKGROUND: Young men who have sex with men (YMSM) are disproportionately impacted by the HIV epidemic in the USA, and a large number of new infections among YMSM occur in the context of main or primary partnerships. At the same time, healthy romantic relationships promote health and wellbeing by improving social support and encouraging healthy behaviors. Thus, we created 2GETHER: a relationship education and HIV prevention program for young male couples. 2GETHER is delivered face-to-face in a university setting and is composed of two group sessions and two individualized skills coaching sessions. We observed strong support of the feasibility, acceptability, and preliminary efficacy of 2GETHER in a pilot trial. METHODS: We are conducting an attention-matched randomized controlled trial (RCT) to test the efficacy of 2GETHER relative to a control condition based on a well-validated positive affect enhancement program. Enrollment occurred between August 2017 and March 2021 in Chicago and surrounding areas, and we enrolled and randomized 128 dyads (N = 256 individuals). Follow-up is ongoing and we will examine primary and secondary behavioral outcomes at 12 months post-intervention, with interim follow-up at 3, 6, and 9 months post-intervention. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up. DISCUSSION: 2GETHER is innovative in that it places an equal emphasis on relationship skill building and HIV prevention. Thus, the program has the potential to impact numerous health-related outcomes. Despite challenges related to the recruitment of couples and the COVID-19 pandemic, we were able to enroll a robust sample of young male couples with sufficient power to detect effects on study outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03186534 .

Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia.

BACKGROUND: Fibromyalgia syndrome (FMS) is a leading cause of functional limitations and disability for which there is no cure. Positive psychological interventions for improving health have received increasing attention, but evidence of the feasibility, acceptability, and impact of such interventions in adult populations with FMS is limited. OBJECTIVES: To describe the rationale and design of a 5-week, online positive affect skills intervention, LARKSPUR: Lessons in Affect Regulation to Keep Stress and Pain UndeR control. METHODS: FMS participants (N = 90) will be randomized to one of two conditions: (1) LARKSPUR or (2) emotion reporting/attention control. LARKSPUR is an online multicomponent intervention that targets eight skills to help foster positive affect: (1) noticing positive events, (2) savoring positive events, (3) identifying personal strengths, (4) behavioral activation to set and work toward attainable goals, (5) mindfulness, (6) positive reappraisal, (7) gratitude, and (8) acts of kindness. The primary outcomes include feasibility (i.e., recruitment, retention, adherence) and acceptability (i.e., helpfulness, usability, satisfaction). Secondary outcomes include pain intensity and pain interference. SIGNIFICANCE: If feasibility and acceptability metrics are met and reductions in pain outcomes are achieved, we will undertake future efficacy and effectiveness trials of LARKSPUR among older adults with FMS. TRIAL REGISTRATION: NCT04869345.

Development of a Positive Psychology Program (LAVENDER) for Preserving Medical Student Well-being: A Single-Arm Pilot Study.

BACKGROUND: Mental health tends to worsen over the course of medical school, with steep declines in well-being in students' clerkship year (M3). Positive emotion promotes adaptive coping to stress and may help preserve medical student well-being. OBJECTIVE: This study describes the development of LAVENDER (Leveraging Affect and Valuing Empathy for Nurturing Doctors' Emotional Resilience), a program aimed at increasing positive emotion to preserve well-being in medical students. METHODS: We conducted a single-arm pilot of LAVENDER, a positive psychology intervention developed for medical students delivered in an interactive classroom format to a cohort of 157 third-year medical students at the Albert Einstein College of Medicine. Our primary outcome was the acceptability of LAVENDER. We also examined preliminary efficacy using measures of emotion, stress and burnout collected at each intervention session. RESULTS: LAVENDER showed good acceptability: 76% of participants agreed that the LAVENDER skills were useful and 72% agreed that they would recommend the LAVENDER program to others. Qualitative feedback suggested that medical students enjoyed the program and found the skills to be useful for coping with stress, but also reported the following barriers to engagement: lack of time to practice the skills, resistance to the mandatory nature of the wellness sessions, and difficulty integrating the skills in daily life. We did not find support for the preliminary efficacy of LAVENDER for improving medical student well-being in students' clerkship year. Participants showed decreases in positive emotion and increases in symptoms of burnout over the intervention period (ps < .01). CONCLUSION: The current paper describes the development and a single-arm pilot test of LAVENDER, a positive psychology program tailored for medical students. Although we found preliminary evidence for the acceptability of LAVENDER, we did not find support for the preliminary efficacy. Lessons learned and next steps for the program are discussed.

Who is most likely to benefit from a positive psychological intervention? Moderator analyses from a randomized trial in people newly diagnosed with HIV.

The Intervention for those Recently Informed of their Seropositive Status (IRISS) and other positive psychological interventions (PPIs) have demonstrated psychological and physical health benefits. However, meta-analyses suggest that PPIs may have differential effects depending on participants' sociodemographic and psychological characteristics. We therefore examined potential moderators of effects of IRISS for adults newly diagnosed with HIV (N=159). While IRISS had similar effects on positive emotion across most subgroups (age, race, education, stress), depression was a significant moderator for positive emotion. When examining effects of IRISS on antidepressant use, age, race, education, depression, and perceived stress emerged as significant moderators. Neither optimism nor life events significantly moderated effects of IRISS on any outcome. Results have clinical implications that practitioners can use to inform which patients are most likely to benefit from PPI.

Positive affect skills may improve pain management in people with HIV.

Non-opioid pain management strategies are critically needed for people with HIV. We therefore conducted a secondary analysis of pain-related outcomes in a randomized controlled trial of a positive affect skills intervention for adults newly diagnosed with HIV (N = 159). Results suggest that, even if pain prevalence rises, positive affect skills may reduce pain interference and prevent increased use of opioid analgesics by people living with HIV. Future research should replicate and extend these findings by conducting trials that are specifically designed to target pain outcomes.

Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.

The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist control arm that receives MBSR following a 16-week period of standard care. Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness) are assessed at baseline and weeks 8, 16, and 48 in both groups, with an additional assessment at week 24 (post-MBSR) in the crossover control group. Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs). In addition, a subset of participants (n = 30 per group) are randomly selected to undergo fMRI to evaluate changes in functional connectivity networks and their relationship to changes in neuropsychological outcomes. Forthcoming findings from this randomized controlled trial have the potential to contribute to a growing public health need as the number of older adults with HAND is expected to rise.

A Scoping Review of Positive Lifestyle and Wellness Interventions to Inform the Development of a Comprehensive Health Promotion Program: "HealthPro".

Background. Lifestyle medicine has emerged as a transformational force in mainstream health care. Numerous health promotion and wellness programs have been created to facilitate the adoption of increased positive, modifiable health behaviors to prevent and lessen the effects of chronic disease. This article provides a scoping review of available health promotion interventions that focus on healthy adult populations in the past 10 years. Methods. We conducted a scoping review of the literature searching for health promotion interventions in the past 10 years. Interventions were limited to those conducted among healthy adults that offered a face-to-face, group-based format, with positive results on one or more health outcomes. We then developed a new health promotion intervention that draws on multiple components of included interventions. Results. Fifty-eight articles met our inclusion criteria. Physical activity was the primary focus of a majority (N = 47) of articles, followed by diet/nutrition (N = 40) and coping/social support (N = 40). Conclusions. Efficacious health promotion interventions are critical to address the prevention of chronic disease by addressing modifiable risk factors such as exercise, nutrition, stress, and coping. A new intervention, discussed is this article, provides a comprehensive approaches to health behavior change and may be adapted for future research.