Application of "Internet+" cognitive-behavioral intervention in caregivers of children with congenital heart disease undergoing elective surgery during the COVID-19 pandemic.

OBJECTIVE: To explore the effects of cognitive and behavioral interventions for caregivers of children undergoing interventional surgery for congenital heart disease (CHD) during COVID-19. METHODS: A prospective study was conducted on 140 children with CHD who were hospitalized in the Department of Cardiology in a children's hospital from March 2020 to March 2022. The children were randomly divided into an intervention group and a control group, with 70 cases in each group. In the control group, caregivers gave routine care, and in the intervention group, "Internet+" cognitive and behavioral interventions were given. The psychological status of caregivers before and after intervention, day care ability on the operation day, readiness for hospital discharge of the caregivers, sleep quality, and postoperative complications of the children, the medication compliance, review compliance and satisfaction were compared between the two groups. RESULTS: During the COVID-19 pandemic, the anxiety and depression scores of caregivers in the intervention group were significantly lower than those in the control group (P<0.05), and the caregiving ability and readiness for hospital discharge of the caregivers in the intervention group were better than those in the control group (P<0.05). The sleep quality of children in the intervention group was significantly better than that in the control group during the first week after operation (P<0.05). Postoperative complications were significantly fewer in the intervention group than in the control group (χ 2=24.433, P<0.001). The medication compliance, review compliance, and satisfaction were higher in the intervention group than in the control group (P<0.05). CONCLUSION: During the pandemic period of COVID-19, "Internet+" cognitive and behavioral intervention has a good effect and should be promoted in clinical practice.

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol.

BACKGROUND: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression. METHODS: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30-40 min sessions plus treatment-as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator. CONCLUSIONS: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT. CLINICALTRIALS: govregistration: NCT05540067.

The role of human support and online depression prevention for adolescents

Depression is a mental health disorder that is impacting youth within the United States at high rates. It is estimated that 3.2 million youth in the United States have experienced at least one major depressive episode. The rate of depression in youth is increasing over time. Depression poses a high risk to youth for general poorer life outcomes such as worse academic performance, suicidal behavior, physical health problems, and comorbid mental health problems. Depression presents a significant burden to society with adverse financial implications and substantial costs to the public health sector. It is imperative to direct resources and research into depression prevention efforts. Some prevention efforts have included online programs. CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training) is an internet-based depression prevention program for adolescents that has shown to reduce depression in subsyndromal youth (Van Voorhees, Ellis, et al., 2005;Van Voorhees, Paunesku, et al., 2008). Coupled with the Internet program, participants received human support measures (e.g., contacts, motivational interviews) to supplement the online depression prevention program. However, research on the effect of human support on engagement and depressive clinical outcomes in youth has produced mixed results when looking at the effects over time. This study is a secondary analysis that seeks to understand how human support impacts the relationship between the efficacy of CATCH-IT on overall level of engagement with the intervention and clinical depression scores. Given the emerging utilization of telemental health and digital tools to provide treatment in the context of COVID-19, behavioral intervention technologies (BITs) targeting adolescent depression may become a therapeutic forefront to the peri- and post-pandemic period. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Cognitive-behavioral and dietary weight loss intervention in adult kidney transplant recipients with overweight and obesity: Results of a pilot RCT study (Adi-KTx).

The obesity epidemic and its health consequences have not spared the population of kidney transplant (KTx) candidates and recipients. In addition, KTx recipients are susceptible to weight gain after transplantation. Overweight and obesity after KTx are strongly associated with adverse outcomes. Therefore, we designed a randomized controlled, mono-center study to specifically test the effectiveness of a primarily cognitive-behavioral approach supplemented by nutritional counseling for weight reduction following KTx as the intervention group (IG) in comparison to a brief self-guided intervention as control group (CG). The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00017226). Fifty-six KTx patients with a BMI from 27 to 40 kg/m2 were included in this study and randomized to the IG or CG. Main outcome was the number of participants achieving a 5% weight loss during the treatment phase. Additionally, participants were assessed 6 and 12 months after the end of the 6-month treatment phase. Participants significantly lost weight without group differences. 32.0% (n = 8) of the patients in the IG and 16.7% (n = 4) of the patients in the CG achieved a weight loss of 5% or more. Weight loss was largely maintained during follow-up. Retention and acceptance rate in the IG was high, with 25 (out of 28) patients completing all 12 sessions and one patient completing 11 sessions. Short-term, cognitive-behaviorally oriented weight loss treatment seems to be feasible and acceptable for patients after KTx who suffer from overweight or obesity. This clinical trial was ongoing at the onset of the COVID-19 pandemic which might have influenced study conduct and results. Clinical Trial Registration: https://clinicaltrials.gov/ DRKS-ID: DRKS00017226.

Low Treatment Fidelity as an Indication to Switch Interventions: Pivoting From Child-Parent Psychotherapy to Parent-Child Interaction Therapy for Early Childhood Trauma

Young children who experience trauma and adverse experiences are at an increased risk of developing an insecure attachment style as well as negative physical and mental health problems. These can include internalizing and externalizing behavioral problems, developmental delay, emotional dysregulation, and aggression. Several evidence-based interventions exist to treat young children with symptoms related to trauma, each with different foundational theories. This article presents the case of a 4-year-old boy with posttraumatic stress disorder who was in the middle of a legal fight between caregivers and transitioning between caregivers' homes. Initially, therapy began with Child-Parent Psychotherapy to address caregivers' first concerns. Later, the therapeutical approach was switched to Parent-Child Interaction Therapy due to difficulty with treatment fidelity related to caregivers' symptoms and conflict. This case demonstrates great improvement in treatment fidelity and subsequently problem behaviors after switching to an intervention that allowed to address behavior management shortcomings in a family with ongoing conflict.Copyright © The Author(s) 2022.

Improving student academic productivity within remote instruction: Investigating the effectiveness of virtual CICO

School Wide Positive Behavior Intervention and Supports is a framework by which schools can assess and develop a system of preventative strategies to decrease the likelihood of problematic behaviors. SWPBIS provides for a three tiered system of interventions with increasing supports and complexity to meet students' needs at each level. CICO was developed as a Tier 2 procedure to be implemented for students that are not demonstrating responsiveness to Tier 1 interventions within a well-developed SWPBIS framework and is intended to be implemented with students that are exhibiting disruptive non-dangerous problematic behaviors such as calling out, out of seat behavior, low productivity, and non-compliance. The research which supports the potential flexibility of CICO intervention's applicability across a wide range of modifications empowers school administrators, teachers, and behavior specialists with the confidence to apply variations of these procedures to atypical circumstances that may arise. In March of 2020, the COVID-19 global pandemic prompts schools across America to implement a novel instructional approach which allows students to attend school remotely through online access. The move towards online schooling requires a re-imagining of how behavioral support can be delivered through virtual instruction. This study reviewed the application and effectiveness of the use of Check In/ Check Out (CICO) implemented virtually during remote instruction through a commonly shared computer based platform (i.e. Google Classroom). (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings.

BACKGROUND: Almost half of the patients with cancer report cancer-related financial hardship, termed "financial toxicity" (FT), which affects health-related quality of life, care retention, and, in extreme cases, mortality. This increasingly prevalent hardship warrants urgent intervention. Financial navigation (FN) targets FT by systematically identifying patients at high risk, assessing eligibility for existing resources, clarifying treatment cost expectations, and working with patients and caregivers to develop a plan to cope with cancer costs. This trial seeks to (1) identify FN implementation determinants and implementation outcomes, and (2) evaluate the effectiveness of FN in improving patient outcomes. METHODS: The Lessening the Impact of Financial Toxicity (LIFT) study is a multi-site Phase 2 clinical trial. We use a pre-/post- single-arm intervention to examine the effect of FN on FT in adults with cancer. The LIFT trial is being conducted at nine oncology care settings across North Carolina in the United States. Sites vary in geography (five rural, four non-rural), size (21-974 inpatient beds), and ownership structure (governmental, non-profit). The study will enroll 780 patients total over approximately 2 years. Eligible patients must be 18 years or older, have a confirmed cancer diagnosis (any type) within the past 5 years or be living with advanced disease, and screen positive for cancer-related financial distress. LIFT will be delivered by full- or part-time financial navigators and consists of 3 components: (1) systematic FT screening identification and comprehensive intake assessment; (2) connecting patients experiencing FT to financial support resources via trained oncology financial navigators; and (3) ongoing check-ins and electronic tracking of patients' progress and outcomes by financial navigators. We will measure intervention effectiveness by evaluating change in FT (via the validated Comprehensive Score of Financial Toxicity, or COST instrument) (primary outcome), as well as health-related quality of life (PROMIS Global Health Questionnaire), and patient-reported delayed or forgone care due to cost. We also assess patient- and stakeholder-reported implementation and service outcomes post-intervention, including uptake, fidelity, acceptability, cost, patient-centeredness, and timeliness. DISCUSSION: This study adds to the growing evidence on FN by evaluating its implementation and effectiveness across diverse oncology care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04931251. Registered on June 18, 2021.

Acceptability and feasibility of a brief behavioral sleep intervention for youth with CF.

Youth with CF are at increased risk for physiological and behavioral sleep difficulties due to disease-specific symptoms and more general pediatric sleep challenges. Despite evidence suggesting that behavioral sleep interventions are effective for improving common sleep difficulties, no interventions exist for youth with CF. SLEEP-CF was designed to fill this gap by providing tailored, flexible behavioral sleep support to youth with CF. Results suggest that SLEEP-CF is an acceptable and feasible behavioral sleep intervention, even in a population with normative sleep habits. There may be benefit in terms of improving sleep knowledge and sleep hygiene. Technology use during and after bedtime is prevalent. CF care team members are encouraged to assess sleep as part of routine CF care, and to provide support as indicated.

Sound healing reduces generalized anxiety during the pandemic: A feasibility study.

OBJECTIVES: This study examined the feasibility and effectiveness of a virtually-delivered, biofield-based sound healing treatment to reduce anxiety for individuals meeting criteria for Generalized Anxiety Disorder. DESIGN: This one-group, mixed-method feasibility study was conducted virtually via Zoom during the SARS-CoV-2 Pandemic. Fifteen participants with moderate to high levels of anxiety as determined by the Generalized Anxiety Disorder-7 (≥10), were enrolled. INTERVENTION: Five certified Biofield Tuning Practitioners performed the interventions. Participants were given three weekly, hour-long sound healing treatments virtually, over a month's period. OUTCOME MEASURES: Attrition rates and reports on feasibility of intervention delivery and outcomes assessment were obtained by participants. Data on anxiety, positive and negative affect, spiritual experience, perceived stress, and quality of life were obtained via validated surveys and analyzed via repeated-measures analysis of variance with intention-to-treat. Linguistic inquiry and word count was utilized to assess changes in affective processing as reflected in participants' spoken words over the course of the intervention. Qualitative interviews were conducted to further determine tolerability and experiences with receiving BT that may not have been captured by survey and language data. RESULTS: Attrition rates were 13.3%, with two participants dropping out of the study after one session. The remaining participants reported acceptability of the data collection process and intervention delivery. Intention to treat analyses revealed statistically significant reductions in anxiety (State-Trait Anxiety Inventory), negative affect (Positive and Negative Affect Scale), and perceived stress (Perceived Stress Scale) (p < .001 in all cases). Linguistic and word count analysis revealed a significant linear decrease (p = .01) of participants' use of negative affect words over the course of the intervention. Qualitative data results are reported in another paper. CONCLUSIONS: Results indicate that BT delivered virtually is feasible and amenable to study, and that the impact of BT may be substantial in reducing anxiety and improving mental health. This is the first study of its kind to report clinically significant reductions in anxiety levels in response to a virtually-delivered, biofield-based sound therapy. Data will be used to power a randomized controlled trial to more deeply examine the effects of BT on whole-person healing for those suffering from anxiety.

Loss-framing of information and pre-vaccination consultation improve COVID-19 vaccine acceptance: A survey experiment.

Backgrounds: Vaccination remains one of the most effective ways to protect populations from COVID-19 infection, severe conditions, and death. This study aims to examine whether the gain/loss-framing of information, provision of subsidized pre-vaccination physician consultation, and cash incentives can improve COVID-19 acceptance amongst adults. Methods: A survey experiment was conducted within a broader cross-sectional survey of people aged 18-64 years in Hong Kong, China. The participants were randomly assigned to one of the eight groups derived from full-factorial design of the three strategies with stratification by age and sex. The vaccine acceptance rate was compared between people with and without any of the strategies. The heterogeneous effects of these strategies were identified for those with different perceptions of the pandemics and vaccine in multiple logistic regressions. Results: The survey experiment collected 1,000 valid responses. It found that loss-framed information and provision of subsidized physician consultation to assess suitability to be vaccinated, can improve vaccine acceptance, while cash incentives did not make a difference. The improvement effect of loss-framing information and physician consultation is stronger among those with higher perceived infection risk and severity of condition, as well as unvaccinated people with lower confidence in vaccine safety. Conclusions: The findings indicated that individualized loss-framing messages and equitable provision of subsidized pre-vaccination physician consultations can be incorporated in efforts to promote vaccine acceptance and vaccination roll-out speed. However, it remains inconclusive whether and how universal cash incentives may be deployed to support vaccination promotion.

A digitally enhanced home-based physical activity intervention for high-risk middle school youth during COVID-19.

COVID-19 significantly impacted physical activity among high-risk youth. Camp from Home, a digitally enhanced home-based intervention, was developed to address physical activity disparities among middle school youth during COVID-19. Camp from Home enrolled 62 youth in 54 families from five schools in Philadelphia during the summer of 2020. The 6-week intervention comprised of (1) three home deliveries of "activity kits" including exercise equipment and activity booklets, (2) asynchronous sport and exercise videos posted to a private YouTube channel, and (3) supportive text-messages from health coaches. YouTube analytics and self-report surveys completed by parents and youth at baseline and at the end of programming were used to assess engagement, acceptability, and preliminary efficacy. Youth participants were 12.4 (1.2) years, 38.7% female and 90.3% Black/African American. At follow-up, 41 parents (75.9%) and 34 youth (54.8%) completed measures. Youth self-reported increases in self-efficacy (ΔM(sd) = 0.4(1.0), p = .03) and physical activity (ΔM(sd) = 4.2(7.9), p = .004), despite suboptimal engagement in digital program components. Overall, participants highly rated the program. Activity kits and text-messages from health coaches were rated as most helpful. Most parents (95.1%) and youth (83.8%) expressed interested in participating again in the future. A 6-week digitally enhanced, home-based physical activity intervention was acceptable and feasible among parents and youth during the summer of 2020, with youth reporting improvements in self-efficacy and physical activity. Summer programs are critical for reducing disparities in physical activity and hold potential for addressing key barriers for high-risk youth even outside the context of COVID-19.

Multisite randomized feasibility study of Problem-Solving Training for care partners of adults with traumatic brain injury during inpatient rehabilitation.

BACKGROUND: Problem-Solving Training (PST) during inpatient rehabilitation could provide care partners the skills needed to manage their life roles after discharge. OBJECTIVE: Determine the feasibility of PST+ Education versus Education for care partners of adults with traumatic brain injury (TBI) during inpatient rehabilitation. METHODS: We conducted a multisite randomized feasibility trial across three sites. We present recruitment rates, reasons for refusal to participate, and reasons for non-completion of interventions. We measured client satisfaction, participant engagement, and fidelity for both interventions. We compared change in depressive symptoms and caregiver burden between PST and Education groups. RESULTS: Though the interventions were generally feasible, recruitment and retention rates were lower than anticipated largely due to the COVID-19 pandemic. Participants who completed >3 sessions were less likely to be employed full-time and more often spouses and co-residing. Length of inpatient rehabilitation stay was correlated with number of sessions completed. We observed potential benefits of PST over Education, specifically for reducing depression symptoms and caregiver burden. CONCLUSION: High satisfaction, engagement, and fidelity, overall recruitment and retention, and positive change in outcomes suggest that PST is generally feasible and beneficial for care partners of persons with TBI. Adaptations, such as developing a 3-session version of PST, could improve feasibility.

Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy.

OBJECTIVE: Non-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The current study examined the feasibility, acceptability, and satisfaction of a social norms adherence intervention in adolescents with epilepsy. METHODS: A pilot RCT of a mHealth social norms intervention was conducted with adolescents with epilepsy who demonstrated non-adherence (≤95% adherence) during baseline. Adolescents were randomized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adherence, seizure severity, and health-related quality of life (HRQOL). RESULTS: One hundred four adolescents were recruited (53% female; Mage = 15.4 ± 1.4 years; 81% White: Non-Hispanic; 5% Black, 10% Bi/Multiracial; 2% White: Hispanic; 1% Other: Hispanic; 1% Bi/Multiracial-Hispanic). Forty-five percent screen-failed due to high adherence, 16% withdrew, and 38% were randomized to treatment (n = 19) or control (n = 21). Recruitment (75%), retention (78%), and treatment satisfaction were moderately high. Engagement with the intervention was moderate, with 64% of participants engaging with intervention notifications. Exploratory analyses revealed that after controlling for COVID-19 impact, the social norms intervention group maintained higher adherence over time compared to the control group. Small to moderate effect sizes were noted for seizure severity and HRQOL between groups. CONCLUSION: This pilot intervention appeared feasible and acceptable. Increases in adherence in the treatment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial.

BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.

Improving student academic productivity within remote instruction: Investigating the effectiveness of virtual CICO

School Wide Positive Behavior Intervention and Supports is a framework by which schools can assess and develop a system of preventative strategies to decrease the likelihood of problematic behaviors. SWPBIS provides for a three tiered system of interventions with increasing supports and complexity to meet students' needs at each level. CICO was developed as a Tier 2 procedure to be implemented for students that are not demonstrating responsiveness to Tier 1 interventions within a well-developed SWPBIS framework and is intended to be implemented with students that are exhibiting disruptive non-dangerous problematic behaviors such as calling out, out of seat behavior, low productivity, and non-compliance. The research which supports the potential flexibility of CICO intervention's applicability across a wide range of modifications empowers school administrators, teachers, and behavior specialists with the confidence to apply variations of these procedures to atypical circumstances that may arise. In March of 2020, the COVID-19 global pandemic prompts schools across America to implement a novel instructional approach which allows students to attend school remotely through online access. The move towards online schooling requires a re-imagining of how behavioral support can be delivered through virtual instruction. This study reviewed the application and effectiveness of the use of Check In/ Check Out (CICO) implemented virtually during remote instruction through a commonly shared computer based platform (i.e. Google Classroom). (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Effectiveness of a Brief Mindfulness-Based Intervention of "STOP touching your face" During the COVID-19 Pandemic: a Randomized Controlled Trial.

Objectives: Avoiding touching the eyes, nose, and mouth (T-zone) is a strategy to reduce the spread of COVID-19. This study evaluated the effectiveness of a brief mindfulness-based intervention (MBI) named "STOP (Stop, Take a Breath, Observe, Proceed) touching your face" for reducing face-touching behavior. Methods: In this online-based, two-arm, wait-list, randomized controlled trial, eligible participants were randomly assigned to the intervention (n = 545) or control group (n = 545). The results of 60-min self-monitoring of face-touching behavior were reported before and after the intervention. Reduction of the percentage of T-zone touching was the primary outcome, and reduction of face-touching frequency was a key secondary outcome. Outcomes were analyzed on an intention-to-treat (ITT) basis with a complete case analysis (CCA). Results: ITT analysis revealed that the percentage of T-zone touching was significantly reduced by 8.1% in the intervention group (from 81.1 to 73.0%, RR = 0.901, OR = 0.631, RD = - 0.081, p = 0.002), and insignificantly reduced by 0.6% in the control group (from 80.0 to 79.4%, p = 0.821). Fewer participants performed T-zone touching in the intervention group than in the control group (73.0% vs. 79.4%, RR = 0.919, OR = 0.700, RD = - 0.064, p = 0.015) after the intervention, and there was a greater reduction of T-zone touching frequency in the intervention group than in the control group [mean ± SD: 1.7 ± 5.13 vs. 0.7 ± 3.98, mean difference (95% CI): 1.03 (0.48 to 1.58), p < 0.001, Cohen's d = - 0.218]. The above results were further confirmed by CCA. Conclusions: This brief mindfulness-based intervention was potentially effective at reducing the spread of COVID-19 and could be further investigated as an intervention for preventing other infectious diseases spread by hand-to-face touching. Trial Registration: ClinicalTrials.gov NCT04330352. Supplementary Information: The online version contains supplementary material available at 10.1007/s12671-022-02019-x.

Wellness Achieved through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls with Overweight or Obesity.

Background: Obesity prevalence among adolescent girls continues to rise. Acceptance-based therapy (ABT) is effective for weight loss in adults and feasible and acceptable for weight loss among adolescents. This pilot randomized controlled trial (RCT) assessed effectiveness of an adolescent-tailored ABT intervention on decreasing weight-related outcomes and improving psychological outcomes compared with enhanced care. Methods: In this 6-month, two-arm pilot RCT, participants were randomized to the ABT intervention or to enhanced care. The ABT intervention condition attended 15 virtual, 90-minute group sessions. The enhanced care comparison received 15 healthy lifestyle handouts and virtually met twice with a registered dietitian. The primary outcome assessed was change in BMI expressed as a percentage of the 95th percentile (%BMIp95). Results: Participants included 40 girls (ages 14-19) assigned to ABT (n = 20) or enhanced care (n = 20). A decrease in %BMIp95 was observed within the ABT intervention [d = -0.19, 95% confidence interval, CI: (-0.36 to -0.02)], however, not within the enhanced care comparison [d = -0.01, 95% CI: (-0.09 to 0.07)]. The ABT group showed slight changes in psychological flexibility [d = -0.34, 95% CI: (-0.62 to -0.06)] over enhanced care [d = -0.11, 95% CI: (-0.58 to 0.37)]. There was no significant intervention effect noted between groups. Conclusion: In this pilot RCT, the ABT intervention was as effective as enhanced care for weight loss. However, previous ABT studies occurred in person, and this study was conducted virtually due to COVID-19. Thus, future research investigating the potential effectiveness of ABT in-person among adolescents and optimization of virtual interventions is needed.

Innovative participatory evaluation methodologies to assess and sustain multilevel impacts of two community-based physical activity programs for women in Colombia.

BACKGROUND: Community-based physical activity (PA) programs are appealing to women in Latin America and show potential for improving women's health. This study aimed to engage healthy middle-aged women, breast cancer survivors and local stakeholders participating in two publicly funded community-based PA programs in Bogotá, Colombia (Recreovía and My Body) to assess and visually map the perceived barriers, facilitators, and outcomes to promote programs' improvement, scaling and sustainability. METHODS: We used two participatory action research methods, the 1) Our Voice citizen science method to capture data and drive local change in built and social environmental facilitators and barriers that influence women's engagement in community-based PA; and 2) Ripple Effects Mapping to visually map the intended and unintended outcomes of PA programs. We used thematic analysis to classify the results at the individual, social, and community levels. RESULTS: The stakeholders engaged in the participatory evaluation included cross-sector actors from the programs (N = 6) and program users (total N = 34) from the two programs (Recreovía N = 16; My Body N = 18). Program users were women with a mean age of 55.7 years (SD = 8.03), 65% lived in low-income neighborhoods. They identified infrastructure as the main feature affecting PA, having both positive (e.g., appropriate facilities) and negative (e.g., poorly built areas for PA) effects. Regarding program improvements, stakeholders advocated for parks' cleaning, safety, and appropriate use. The most highlighted outcomes were the expansion and strengthening of social bonds and the engagement in collective wellbeing, which leveraged some participants' leadership skills for PA promotion strategies in their community. The facilitated dialogue among program users and stakeholders fostered the sustainability and expansion of the community-based PA programs, even during the COVID-19 pandemic. CONCLUSIONS: The implementation of both participatory methodologies provided a multidimensional understanding of the programs' impacts and multisectoral dialogues that fostered efforts to sustain the community-based PA programs.

Recruitment strategies for a post cessation weight management trial: A comparison of strategy cost-effectiveness and sample diversity.

Background: Effective recruitment of representative and diverse samples in research trials is important to the generalizability of findings and in describing access to behavioral interventions. The current study evaluated the effectiveness of local and national recruitment strategies for a smoking cessation and weight management-focused randomized controlled trial (Fit & Quit). The overall cost-effectiveness of recruitment strategies was also evaluated. Methods: The study initially recruited participants locally in the Memphis, TN area and later transitioned to national recruitment, necessitated by the transition to remote assessment strategies due to the COVID-19 pandemic. The study evaluated effective recruitment strategies for randomized participants (n = 305) across gender, race, rurality, and recruitment method, as well as the cost-effectiveness of methods used during the recruitment period of this study. Results: The most effective recruitment strategies were local postcards, local radio advertisements, word-of-mouth referrals, and national internet advertisements, which resulted in a combined 71.8% (n = 219) of the total randomized sample (n = 305). Radio advertisements were the best method for recruiting Black participants. Electronic recruitment strategies were the most effective method for non-urban participants. Additionally, gender, recruitment method, race, and rurality predicted randomization. Overall, electronic media methods were more cost-effective ($430.97 per participant) compared to traditional media methods ($931.43 per participant); however, traditional media methods resulted in a greater number of recruited and randomized participants. Conclusion: Results provide information on effective and cost-effective local and national recruitment methods for recruiting underrepresented groups of participants in behavioral clinical intervention studies.

Notes from an epicenter: navigating behavioral clinical trials on autism spectrum disorder amid the COVID-19 pandemic in the Bronx.

BACKGROUND: The COVID-19 pandemic impacted nearly all facets of our daily lives, and clinical research was no exception. Here, we discuss the impact of the pandemic on our ongoing, three-arm randomized controlled trial (RCT) Sensory Integration Therapy (SIT) in Autism: Mechanisms and Effectiveness (NCT02536365), which investigates the immediate and sustained utility of SIT to strengthen functional daily-living skills and minimize the presence of maladaptive sensory behaviors in autistic children. MAIN TEXT: In this text, we detail how we navigated the unique challenges that the pandemic brought forth between the years 2020 and 2021, including the need to rapidly adjust our study protocol, recruitment strategy, and in-person assessment battery to allow for virtual recruitment and data collection. We further detail how we triaged participants and allocated limited resources to best preserve our primary outcome measures while prioritizing the safety of our participants and study team. We specifically note the importance of open and consistent communication with all participating families throughout the pandemic in ensuring all our protocol adjustments were successfully implemented. CONCLUSIONS: Though the COVID-19 pandemic resulted in an unprecedented interruption to in-person clinical research, clinical trials have always been and will continue to be at risk for unforeseen interruptions, whether from world events or participants' personal circumstances. By presenting our steps to preserving this RCT throughout the pandemic, we offer suggestions for successfully managing unexpected interruptions to research. Ideally, by taking these into account, future RCTs may be increasingly prepared to minimize the impact of these potential interruptions to research.