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.

Acceptability and Feasibility of a Socially Enhanced, Self-Guided, Positive Emotion Regulation Intervention for Caregivers of Individuals With Dementia: Pilot Intervention Study.

BACKGROUND: The responsibilities of being a primary caregiver for a loved one with dementia can produce significant stress for the caregiver, leading to deleterious outcomes for the caregiver's physical and psychological health. Hence, researchers are developing eHealth interventions to provide support for caregivers. Members of our research team previously developed and tested a positive emotion regulation intervention that we delivered through videoconferencing, in which caregiver participants would meet one-on-one with a trained facilitator. Although proven effective, such delivery methods have limited scalability because they require significant resources in terms of cost and direct contact hours. OBJECTIVE: This study aimed to conduct a pilot test of a socially enhanced, self-guided version of the positive emotion regulation intervention, Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF). Studies have shown that social presence or the perception of others in a virtual space is associated with enhanced learning and user satisfaction. Hence, the intervention leverages various social features (eg, discussion boards, podcasts, videos, user profiles, and social notifications) to foster a sense of social presence among participants and study team members. METHODS: Usability, usefulness, feasibility, and acceptability data were collected from a pilot test in which participants (N=15) were given full access to the SAGE LEAF intervention over 6 weeks and completed preintervention and postintervention assessments (10/15, 67%). Preliminary outcome measures were also collected, with an understanding that no conclusions about efficacy could be made, because our pilot study did not have a control group and was not sufficiently powered. RESULTS: The results suggest that SAGE LEAF is feasible, with participants viewing an average of 72% (SD 42%) of the total available intervention web pages. In addition, acceptability was found to be good, as demonstrated by participants' willingness to recommend the SAGE LEAF program to a friend or other caregiver. Applying Pearson correlational analyses, we found moderate, positive correlation between social presence scores and participants' willingness to recommend the program to others (r9=0.672; P=.03). We also found positive correlation between social presence scores and participants' perceptions about the overall usefulness of the intervention (r9=0.773; P=.009). This suggests that participants' sense of social presence may be important for the feasibility and acceptability of the program. CONCLUSIONS: In this pilot study, the SAGE LEAF intervention demonstrates potential for broad dissemination for dementia caregivers. We aim to incorporate participant feedback about how the social features may be improved in future iterations to enhance usability and to further bolster a sense of social connection among participants and study staff members. Next steps include partnering with dementia clinics and other caregiver-serving organizations across the United States to conduct a randomized controlled trial to evaluate the effectiveness of the intervention.

Acupuncture after valve surgery is feasible and shows promise in reducing postoperative atrial fibrillation: The ACU-Heart pilot trial.

Objective: Acupuncture is an effective treatment for arrythmias and postoperative symptoms but has not been investigated after cardiac surgery. Acupuncture After Heart Surgery is a prospective, randomized, controlled pilot trial of daily inpatient acupuncture or standard care after valve surgery with the primary end point being feasibility and secondary end points being reduction in postoperative atrial fibrillation incidence and postoperative symptoms. Methods: A total of 100 patients without a history of atrial fibrillation underwent primary valve surgery via sternotomy and randomized 1:1 to acupuncture (51) or standard care (49). The acupuncture group received daily inpatient sessions starting on postoperative day 1. Postoperative symptoms (pain, nausea, stress, anxiety) were assessed once daily in the standard care group and before/after daily intervention in the acupuncture group. The groups were comparable except for age (acupuncture: 55.6 ± 11.4 years, standard care: 61.0 ± 9.3 years; P = .01). Results: The Acupuncture After Heart Surgery pilot trial met primary and secondary end points. There were no adverse events. An average of 3.8 (±1.1) acupuncture sessions were delivered per patient during a mean hospital stay of 4.6 days (±1.3). Acupuncture was associated with a reduction in pain, nausea, stress, and anxiety after each session (P < .0001), and patients receiving acupuncture had reduced postoperative stress and anxiety across admission compared with standard care (P = .049 and P = .036, respectively). Acupuncture was associated with reduced postoperative atrial fibrillation incidence (acupuncture: 7 [13.7%], standard care: 16 [32.7%]; P = .028), fewer discharges on amiodarone (acupuncture: 5 [9.8%], standard care: 13 [26.5%]; P = .03), and fewer hours in the intensive care unit (acupuncture: 30.3 ± 10.0, standard care: 37.0 ± 22.5; P = .057). Conclusions: Acupuncture after valve surgery is feasible, is well tolerated, and has clinical benefit. The reduction noted in postoperative atrial fibrillation incidence will inform larger trials designed to further investigate the impact of acupuncture on postoperative atrial fibrillation and medical outcomes.

Knowledge of Fertility and Perspectives About Family Planning Among Female Physicians.

Importance: Pervasive gender disparities exist in medicine regarding promotion, achievement of academic rank, and appointment to leadership positions. Fertility and childbearing concerns may contribute to these disparities. Objective: To assess fertility knowledge and concerns and evaluate barriers to family building and impact on academic attrition reported by female physicians. Design, Setting, and Participants: This qualitative study used mixed methods; first, structured 1:1 interviews exploring fertility knowledge and family-building concerns were conducted among 16 female physicians between November 2019 and May 2020. Transcripts were coded in Dedoose and used to develop a survey instrument with subsequent pilot testing conducted among 24 female physicians between April 2020 and September 2020. Data analysis was performed from January 2021 to March 2021. Main Outcomes and Measures: Fertility knowledge, perceptions of peer and institutional support surrounding childbearing, factors contributing to delayed childbearing, and impact of family planning on career decisions. Results: Among 16 women who completed qualitative interviews, 4 (25%) were Asian, 1 (6%) was Black, 1 (6%) was multiracial, and 10 (63%) were White; mean (SD) age was 34.9 (4.0) years. Evaluation of fertility knowledge revealed 3 notable themes: (1) inadequate formal fertility education, (2) informal learning through infertility experiences of patients, peers, or personal struggles, and (3) desire to improve medical education through early introduction and transparent discussions about infertility. Exploration of childbearing concerns similarly revealed several salient themes: (1) high incidence of delayed childbearing, (2) perceived lack of peer and administrative support, and (3) impact of family building on career trajectory. These themes were borne out in pilot testing of the survey instrument: of 24 female physicians (7 Asian women [27%], 1 Black woman [4%], 1 Hispanic or Latinx woman [4%], 1 multiracial woman [4%], 15 White women [58%]; mean [SD] age, 36.1 [6.7] years), 17 (71%) had delayed childbearing and 16 (67%) had altered their career for family-building reasons. Conclusions and Relevance: Qualitative interviews identified fertility and family building concerns among female physicians and were used to develop a tailored survey for women in medicine. These findings suggest that female physicians may delay childbearing and make substantial accommodations in their careers to support family building. A large-scale national survey is needed to better characterize the unique fertility, childbearing, and parenting needs of women in academic medicine to better understand how these concerns may contribute to academic attrition.

Applications of complementary therapies during rehabilitation for individuals with traumatic Spinal Cord Injury: Findings from the SCIRehab Project.

Objective: Evaluate the use of complementary therapies during rehabilitation for patients with traumatic spinal cord injury (SCI). Design: Secondary analyses were conducted to identify the use and associated outcomes of complementary therapies provided by occupational therapists (OTs) and physical therapists (PTs) during rehabilitation from a public dataset. Setting: Inpatient rehabilitation. Participants: A public dataset composed of 1376 patients with SCI that were enrolled in a five-year, multi-center investigation, the SCIRehab Project. Secondary analyses focused on a subset of 93 patients (47 who received complementary therapy during treatment and 46 case-matched controls who received no complementary therapy). Interventions: OTs and PTs recorded use of complementary therapies during sessions, including yoga, Pilates, tai chi, aromatherapy, relaxation techniques, imagery and other. Outcome Measures: Pain interference, pain severity, mobility, and social integration. Results: Three percent of participants received any complementary therapies. Patients who received complementary therapies showed greater reductions in pain severity from 6 months to 12 months relative to matched controls. Furthermore, the amount of time that patients received complementary therapies during physical therapy sessions was associated with reduced pain interference at 6 months and with reduced pain severity at the 6-month and 12-month follow-ups. Complementary therapy use was not associated with mobility or social integration. Conclusion: The current study provides preliminary evidence documenting the limited use of complementary therapies in rehabilitation settings and highlights the opportunity for further research, particularly regarding pain-related outcomes.