Preliminary Effects Research Articles

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). This study was a pilot single-blinded multi-site randomized trial. Two academic medical centers in Pennsylvania (n= 57) and Utah (n= 45), United States participated. One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n= 53) or UC (n= 49). PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6months postpartum. We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) =9.7, 62.1] and some evidence for baseline to 6months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN =7.4 versus UC = -21.3, 95%CI =3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2months (PN = 11.9%/UC = 16.1%) and at 6months postpartum (PN =3.8%/UC =6.2%). Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.

A peer-led learning program about intimate and romantic relationships for persons with mental disorders (AIRIKI): co-creation pilot feasibility study

BackgroundIntimate and romantic relationships are important in life for individuals, irrespective of mental health status. We developed a four-hour peer-led learning program for persons with mental disorders about intimate and romantic relationships through a co-creation process with service users and examined its preliminary effectiveness and feasibility of implementing the program.MethodsA one-group pretest–posttest trial was conducted using a mixed-method design for 45 individuals with mental disorders in Japan. Outcome data were collected at three time points: baseline, post-intervention, and one month after program completion. Mixed models for repeated measures (MMRM) were used to examine changes over time in the Rosenberg Self-Esteem Scale (RSES), Recovery Assessment Scale (RAS), Herth Hope Index (HHI), and the original items. Group interviews were conducted for process evaluation.ResultsMMRM showed significant changes over time on RSES, RAS, HHI, and two original items “I am able to communicate well with others about myself” and “I am able to listen to others well.” In multiple comparisons, RSES and HHI were significant one month after the program. Participants reported changes during the first month after attending the program in terms of their positive attitude toward romantic relationships (n = 14), taking romantic actions (n = 11), and feeling their overall communication improved (n = 11). Although two participants had an unscheduled psychiatric visit that could be attributed to attending the program, all recovered after one month.ConclusionsThe program exhibited preliminary effectiveness to a moderate extent in improving recovery, particularly regarding self-esteem and hope. The program is feasible but requires further modifications regarding inclusion criteria for participants and the training of peer facilitators.Trial registrationUMIN000041743;09/09/2020.

Feasibility, acceptability and preliminary effectiveness of a mental health drop-in centre for the siblings of young people attending a paediatric hospital.

Siblings of children with long-term conditions (LTCs) can have significantly elevated mental health needs, but these are often overlooked. A pragmatic single-arm feasibility pilot assessed feasibility, acceptability and preliminary effectiveness of a drop-in centre in a paediatric hospital addressing mental health needs of patients with LTCs, their carers and siblings. The drop-in centre accepted self-referral and supplemented existing provision offering a suite of interventions, including signposting, diagnostic assessments and/or guided self-help. This paper reports on feasibility, acceptability and preliminary outcomes of this centre for siblings. Eighteen siblings aged 2-17 used the centre. Sixteen of their parents completed the Strengths and Difficulties Questionnaires at baseline and 6months post-baseline, and ten completed parent-reported PedsQL across two time points. Preliminary effectiveness results demonstrated a decrease in mental health symptoms with large effect size (score reduction of 3.44, 95% CI [1.25, 5.63], d = 0.84) and small effect on quality of life, with scores increasing from a median of 69.91, 95% CI [53.57, 91.67], to a median of 80.44, 95% CI [67.39, 89.13], r = 0.11 for these siblings. 88% of parents were satisfied with this provision for their sibling child. This study highlights the feasibility and value of assessing siblings for emotional and behavioural difficulties and providing them with an accessible, effective and acceptable intervention.

Preliminary Effectiveness of a Therapist-Supported Digital Mental Health Intervention in Reducing Suicidal Ideation

Suicidal ideation (SI) is a significant public health concern with increasing prevalence. Therapist-supported digital mental health interventions (DMHI) are an emergent modality to address common mental health problems like depression and anxiety, although less is known about SI. This study examined SI trajectories among 778 patients who participated in a therapist-supported DMHI using multilevel models during and up to 6-months post-treatment. Estimates of associated suicide attempts and deaths by suicide were calculated using published data linking PHQ-9-assessed SI to records of suicide attempts and deaths by suicide. The proportion of participants reporting no SI significantly increased between baseline and end-of-treatment (78.02% to 91.00%). Effect sizes of SI changes between baseline and end-of-treatment, 3-month, and 6-month follow-ups were 0.33 (95%CI = 0.27–0.38), 0.32 (95%CI = 0.27–0.38), and 0.32 (95%CI = 0.27–0.38), respectively. Results also indicated an estimated 30.49% reduction (95%CI = 25.15%-35.13%) in suicide attempts and death by suicide across treatment. This study provides preliminary evidence of the effectiveness of a therapist-supported DMHI in reducing SI.

An Exposure-Based Video Game (Dr. Zoo) to Reduce Needle Phobia in Children Aged 3 to 6 Years: Development and Mixed Methods Pilot Study.

Needle phobia, which affects 19% of children aged 4 to 6 years, prevents many children from receiving necessary or preventive medical treatments. Digital interventions have been made to target needle phobia but currently rely on distraction rather than evidence-based exposure. We designed and evaluated a serious exposure-based mobile game called Dr. Zoo to reduce the fear of needles in children aged 3 to 6 years, where players administered shots to cartoon animals. We conducted a mixed methods study with 30 parents (mean age 35.87, SD 4.39 years) and their 36 children (mean age 4.44, SD 1.11 years) who played the game for 5 days leading to a scheduled appointment that included an injection (eg, influenza vaccination). After the study, parents completed exit surveys and participated in semistructured interviews to evaluate ease of use, acceptability, and preliminary effectiveness of the game and to provide insights on their experience with the game to inform future developments. Interview transcripts were analyzed by 3 independent coders following an open coding process and subsequently coded and discussed to reach consensus. Parents rated their child's difficulty in completing the game as very low on average (scale 1-5; mean 1.76, SD 0.82) and were highly likely to recommend Dr. Zoo to other parents (scale 1-5; mean 4.41, SD 0.87), suggesting Dr. Zoo's strong ease of use and high acceptability. In the exit survey, parents rated their child's fear as significantly lower after participating in the study (scale 1-5; mean 3.09, SD 1.17) compared with that before participating (scale 1-5; mean 4.37, SD 0.81; z score=-4.638; P<.001). Furthermore, 74% (26/35) of the parents reported that the game had a positive impact on their child's fear or perception of needles (only 2 parents reported a negative impact). Qualitative analysis of the interview transcripts revealed potentially important features of the game in this positive impact, such as the game's interactive design, as observed in 69% (24/35) of our participants. The results suggest that an evidence-based serious mobile game can be an easy-to-use, acceptable, and potentially effective intervention for changing young children's fear and perceptions of needles. Leveraging digital interventions may be a potential solution to needle anxiety as a public health concern.

Motivating older adults through immersive virtual exercise (MOTIVE): A randomized pilot study

BackgroundThis study aimed to: 1) determine the feasibility of a virtual reality physical activity intervention among older adults and 2) test the preliminary effectiveness of the intervention at increasing physical activity and 3) decreasing depressive symptoms. MethodsWe included 10 older adults randomized into the Motivating Older Adults Through Immersive Virtual Exercise (MOTIVE) intervention group and 10 randomized into the physical activity education only control group. We analyzed the data using descriptive statistics and linear mixed models, testing the interaction of time and the treatment condition. ResultsParticipants in the intervention group attended an average of 15 out of the 16 sessions. A total of 90% of MOTIVE intervention group participants “completely agreed” that the intervention was acceptable, (compared to 30% of education control group participants). ConclusionThis study supports testing the effectiveness of the intervention at improving physical activity and depressive symptoms in a larger sample of older adults.

Feasibility and preliminary effectiveness of a cognitive-behavioral, family-centered partial hospitalization program for adolescents with anorexia nervosa and atypical anorexia nervosa at six- and twelve-month follow-up.

This study examined the feasibility and preliminary effectiveness of a cognitive-behavioral, family-centered partial hospitalization program (PHP) for adolescents with anorexia nervosa (AN) and atypical AN (AAN), and described the outpatient services received following discharge. Participants (N=31) completed anthropometric and self-report assessments at admission, discharge, and six and twelve months after discharge from the PHP. Descriptive statistics explored markers of feasibility. Paired samples t-tests evaluated changes in weight and eating disorder (ED) symptomatology from admission to discharge, admission to six-month follow-up, and admission to twelve-month follow-up. Descriptive statistics and effect sizes compared symptoms at each timepoint between participants with AN and AAN. Results indicated that we were successful at recruiting greater than 50% of adolescents approached for this study. We collected follow-up data from more than 70% of participants at discharge, but did not meet this retention benchmark at six-month and twelve-month follow-ups. The entire sample demonstrated significant improvements in weight and ED symptomatology from admission to discharge, and generally maintained these improvements at six- and twelve-month follow-up. While descriptive statistics suggested that participants with AN and AAN received similar outpatient services following discharge from the PHP, those with AN experienced greater improvement in self-reported ED symptomatology than those with AAN at six- and twelve-month follow-up. These findings provide preliminary support for the efficacy of PHPs in treating adolescents with AN and AAN. Further research with larger sample sizes should investigate whether adolescents with AAN experience poorer outcomes than those with AN following discharge from a PHP.

Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial.

Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. PrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. Implementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. Lessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. ClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487. DERR1-10.2196/48459.

Assessing the feasibility of SMART Recovery for sexual and gender minority individuals: Results from a feasibility and preliminary outcomes trial

Sexual and gender minority individuals (SGMI; e.g., lesbian, gay, bisexual, transgender, and queer people) experience increased rates of alcohol use disorder and additional barriers to participating in alcohol use interventions compared to their cisgender and heterosexual counterparts. This suggests a need for accessible, evidence-based alcohol use interventions for these populations. Through conducting a feasibility and preliminary effectiveness trial of SMART Recovery, a cognitive-behavioral mutual help group for addictive behaviors, with a sample of SGMI (N = 32), this study evaluated the feasibility and preliminary outcomes of SMART Recovery for reducing alcohol use and related problems for SGMI. Primary feasibility metrics included average number of sessions attended per participant and average number of participants per session; preliminary outcomes were evaluated by comparing alcohol use symptoms at pre- and post-test through a t-test. Results suggest that SMART Recovery is potentially a feasible and effective intervention for SGMI experiencing challenges with alcohol use. On average, participants attended 5.36 sessions (target: 4–6 sessions). The average session was attended by 3.63 participants (tentative target: 5 participants). A comparison of pre and post-tests (n = 13) suggested significantly lower alcohol use among participants at the end of the intervention relative to the beginning (t = 1.92; p < 0.05).

Feasibility Testing of a Web-Based Reproductive Decision Support Tool for Cystic Fibrosis

BackgroundPeople with cystic fibrosis (CF) are increasingly considering their reproductive goals. We developed MyVoice:CF, a web-based patient-centered reproductive decision support tool and assessed its implementation in CF care. MethodsWe conducted a feasibility trial among 18-44-year-old women with CF and multidisciplinary CF providers. Prior to CF clinic visit, patient participants completed a baseline survey, used MyVoice:CF, and assessed acceptability, appropriateness, and usability. After clinic, participants rated impact on reproductive health communication. At 3 months post-use, participants assessed impact on reproductive health outcomes. Provider participants completed a survey and focus group regarding MyVoice:CF feasibility/implementation. We assessed outcomes descriptively. We compared MyVoice:CF's impact on outcomes from baseline to follow-up using McNemar's and Wilcoxon signed rank tests as appropriate. ResultsForty-three patient participants completed baseline surveys and 40 rated MyVoice:CF's feasibility; 10 providers participated. Patient participants rated MyVoice:CF's acceptability as 4.48±0.50 out of 5, appropriateness as 4.61±0.48 out of 5, and usability as 82.25±11.02 (‘A’/excellent). After MyVoice:CF use, participants reported improved reproductive health communication self-efficacy vs. baseline (3.54±1.17vs.3.95±0.93, p<0.001). At baseline, 36% of participants reported any discussion of reproductive goals/plans with their CF team in the past year compared to 59% after first visit post-MyVoice:CF use (p=0.049). Provider participants similarly rated MyVoice:CF as feasible and reported no negative impacts on clinic flow after implementation. ConclusionsMyVoice:CF is acceptable, appropriate, and usable for those with CF. Preliminary effectiveness evaluation suggests that MyVoice:CF improves self-efficacy in and frequency of reproductive health communication. Future studies should further assess MyVoice:CF's impact on reproductive health communication and outcomes.

Cognitive behaviour therapy for pandemic-related anxiety and depression in adolescents: a pilot study of a novel intervention

ABSTRACT Objective Although studies have examined the efficacy of cognitive behaviour therapy for adolescents experiencing depression and anxiety during the COVID-19 pandemic, research has yet to evaluate a theory-informed intervention for pandemic-related psychopathology in this population. Methods A single-group pre-/post-test study design was used to examine a novel therapy for adolescents reporting pandemic-related psychopathology. To meet inclusion criteria, participants had to experience psychological symptoms attributable to, or exacerbated by, the COVID-19 pandemic, as determined by self-report and clinician judgement. A sample of 15 adolescents (M age 16.07, SD = 1.75, range 13–18; 86% female) commenced six sessions of psychological therapy. The primary outcome was pre- to post-change in psychiatric symptoms, with secondary outcomes including pandemic-related fears, behavioural withdrawal, and intolerance of uncertainty. Results Participants reported a significant decrease in psychiatric symptoms from pre- to post-treatment (Hedges’ g = .82) in an intention-to-treat analysis, with 60% of participants demonstrating reliable improvement by the end of treatment. Pandemic-related fears also decreased (Hedges’ g = .72), but other secondary outcomes remained unchanged at the end of the intervention. Conclusions This single-group study provides preliminary effect size estimates for pandemic-adapted cognitive behaviour therapy for adolescents. Further research is needed to rigorously evaluate the efficacy of pandemic-adapted CBT in this population, utilising larger sample sizes and controlled study designs.

Pilot feasibility and acceptability trial of BE REAL’s BodyKind: A universal school-based body image intervention for adolescents

Body dissatisfaction is prevalent among adolescents and a primary risk factor for eating disorders, yet there are few body image interventions for older adolescents that support development of positive body image. Therefore, we assessed the feasibility, acceptability and preliminary effectiveness of BodyKind, a four-lesson, mixed gender, teacher-led, school-based curriculum for older adolescents, that combines principles of self-compassion, compassion for others, cognitive dissonance, and social activism to address contemporary adolescent body image concerns (i.e., appearance bias, comparisons on social media) and strengthen positive body image development. The sample contained 147 adolescents, predominantly racial/ethnic minorities (>95%), 54.8% male, 41.5% female and 4.1% gender-minority students aged 15–18 years (M=16.24, SD=.96) from a low-income, inner-city high school in the Midwestern US. Two teachers received training and delivered the curriculum to students. This single arm, mixed methods trial assessed student and teacher acceptability, teacher fidelity and student intervention outcomes. Despite reasonable teacher fidelity, recruitment/attendance rates, post-intervention data loss (35% attrition) limited evaluations of program effectiveness and study feasibility. Important learnings regarding study feasibility will inform optimisation for future school-based trials. Findings demonstrate high acceptability of BodyKind among teachers and adolescents in a lower socioeconomic school setting, and further randomized controlled effectiveness trials are required.

Behavioral physical activity intervention coupled with standard post-cancer directed treatment care to mitigate chronic pain in childhood cancer survivors: A protocol for a single-center, pilot randomized controlled trial

BackgroundLong term survivors of childhood cancer have a high prevalence of chronic pain. Novel, multidisciplinary approaches to manage pain, are needed to allow for a reduction in the use of opioids for pain management. Physical activity is highly effective in managing chronic pain in children and adolescents, however, evidence about the combination of physical activity intervention and pain medications in chronic pain management in childhood cancer survivors is lacking. The aim of this study is to investigate the feasibility, acceptability and preliminary effects of a behavioral physical activity intervention integrated into standard post cancer directed treatment care to mitigate chronic pain in this unique population. MethodsThis is a single site pilot randomized controlled trial of a 16-week physical activity intervention coupled with standard care. The primary aim is to assess the feasibility and acceptability of the physical activity intervention in childhood cancer survivors with chronic pain. Secondary aims include evaluating the differences in functional and psychosocial outcomes along with self-reported pain scores and cumulative dose of pain medications between the exercise group and standard cancer care group. The physical activity intervention is a home-based program structured to increase patients' physical activity behavior and to favor low intensity bodily movement using aerobic exercise and resistance training. ConclusionsThis study will demonstrate that behavioral supportive measures like physical activity may be a novel means to improve cancer related chronic pain in young survivors of childhood cancer and decrease medication usage for pain along with improvement in functional and psychosocial outcomes.

Digital storytelling intervention to promote HPV vaccination among at-risk Asian immigrant populations: Pilot intervention study.

The high morbidity, mortality, and economic burden attributed to cancer-causing HPV call for researchers to address this public health concern through human papillomavirus (HPV) vaccination. Despite disparities in HPV-associated cancers in Korean and Vietnamese Americans (KAs, VAs) their vaccination rates remain low. Evidence points to the importance of developing culturally and linguistically congruent interventions to improve HPV vaccination rates. Digital storytelling (DST; a specific form of cultural narrative) shows promise as an effective culture-centric health promotion strategy. Study aims were to assess the preliminary effects of an innovative remotely delivered culturally and linguistically congruent DST intervention consisting of stories of personal lived experiences on KA and VA mothers' attitudes and intention in vaccinating their children against HPV. We also examined if the association between attitudes and intention differed by child's sex (boy vs. girl) and by ethnicity (KA vs. KA). Participants were recruited from via multiple outlets (e.g., ethnic minority community organizations, social media, flyers posted in local Asian supermarkets and nail salons). Valid and reliable measures were administered online to collect data pre- and post-intervention. Statistical analysis including descriptive statistics, paired and independent sample t-tests, chi-square, and McNemar's test were used to describe the distributions of variables and to examine differences between subgroups and changes in key variables over time. We estimated logistic regression models to examine associations between mother's HPV- and vaccine-related attitudes and vaccination intention, and to explore if the association between attitudes and vaccination intention differed by the target child's sex or ethnicity. In our sample of 50 KA mothers (mean age = 42.8 years; SD = 4.8) and 114 VA mothers (mean age = 41.5 years; SD = 5.4), 36% of KA and 51% of VA mothers reported children receiving free or reduced-price lunch at school. Mother's attitudes toward HPV and the vaccine (t [163] = 2.49, P = .014) and intention to vaccinate their children improved significantly (2 1 = 18.38, P < .001). The measure of mother's positive attitudes toward HPV and the vaccine was significantly associated with the higher vaccination intention (OR = 0.246, p < .001), adjusting for background variables (sociodemographic characteristics) and other HPV-related variables (family cancer history, prior HPV education, HPV communication with healthcare providers). Findings did not suggest that child's sex or ethnicity moderated association between attitudes and vaccination intention. This brief intervention using digital stories was feasible and showed preliminary effects on promoting KA and VA mothers' intention to vaccinate their children against HPV.

Feasibility, tolerability, and preliminary effectiveness of a concurrent cognitive and physical training intervention in young healthy adults

Feasibility, tolerability, and preliminary effectiveness of a concurrent cognitive and physical training intervention in young healthy adults

An online and telehealth intervention for women diagnosed with gynecological cancer during the COVID-19 pandemic: The Journey Ahead pilot and feasibility trial

Abstract Background: Women diagnosed with gynecological cancer suffer from disease-related and treatment-related symptoms that can result in diminished quality of life and persistent distress. There are few evidence-based treatments to mitigate distress for these survivors. Objective: The aim of this study was to evaluate the feasibility, acceptability, and preliminary effects of Journey Ahead, a blended online and telehealth coaching intervention adapted from the in-person Coping and Communication Intervention. Methods: Fourteen women diagnosed and treated for gynecological cancer completed a baseline survey and were enrolled in Journey Ahead, which consisted of eight online modules and five telehealth coaching calls, and then completed a follow-up survey and treatment evaluation. Results: Acceptance rates (27.5%) and follow-up survey completion (57.1%) were lower than expected. Eighty-six percent of participants logged into the online program, and 64.2% completed it. Eighty-three percent of participants completed four or five of the telehealth sessions, and 35.7% attended one session or did not attend any of the telehealth sessions. The results indicated that this intervention reduced depressive symptoms and cancer-related distress and increased emotional well-being, emotional expression, acceptance, psychological flexibility, and coping efficacy. Conclusions: The results highlight the challenges of recruiting during the COVID-19 pandemic and the importance of collecting detailed information from study participants about how to engage them in fully remote interventions. Overall, this single-arm pilot and feasibility study demonstrated satisfactory feasibility, excellent acceptability, and a promising preliminary impact on psychological outcomes.

Synthesis and biological evaluation of Argemone mexicana-inspired antimicrobials.

Due to the lack of new antimicrobial drug discovery in recent years and an ever-growing prevalence of multidrug-resistant "superbugs", there is a pressing need to explore alternative ways to combat pathogenic bacterial and fungal infections. Building upon our previous work in the field of medicinal phytochemistry, the present study is focused on designing, synthesizing, and testing the altered bioactivity of new variants of two original bioactive molecules found in the Argemone mexicana plant. Herein, we report upon 14 variants of berberine and four variants of chelerythrine that have been screened against a pool of 12 microorganisms (five Gram-positive and four Gram-negative bacteria, and three fungi). Additionally, the crystal structures of two berberine variants are described. Several berberine variants show enhanced antibacterial activity compared to the unaltered plant-derived molecule. We also report promising preliminary tumor cytotoxicity effects for a number of the berberine derivatives.

Initial Experience with the Commercial Electron FLASH Research Extension

The purpose of this study was to introduce a new commercial electron FLASH system that has the potential to become widely available for FLASH researchers globally. In this study, we first present the initial acceptance and commissioning tests for the FLASH system, and second, we highlight preliminary FLASH effect results from our cell studies. A linear accelerator was converted into a commercial research platform with the FLASH Research Extension, enabling the generation of a powerful 16 MeV electron FLASH beam. The dosimetric and stability tests were conducted using various dosimeters (i.e., radiochromic film, optically stimulated luminescent dosimeters (OSLDs), and a plane-parallel ionization chamber). To evaluate the FLASH effect, normal and cancer cell lines were FLASH irradiated using different pulse repetition frequencies (PRF) of 18 pulses/s and 180 pulses/s. The electron FLASH mode was able to generate over 1 Gy per pulse at the isocenter and a dose rate of up to 690 Gy/s near the accessory mount of the Linac gantry head. The charge collected by the plane-parallel ionization chamber at the highest PRF (i.e., 180 pulses/s) showed a linear relationship with the delivered number of pulses (i.e., 1 to 99 pulses) with a coefficient of determination (R2) of 0.9996. The absorbed dose measured using radiochromic film and OSLDs agreed within 3%, on average, and followed an inverse square law as the source-to-axis distance (SAD) varied for which the R2 values were 0.9972 and 0.9955 for radiochromic film and OSLDs, respectively. The profile of the FLASH beam was symmetrical but was not as flat as the conventional 16 MeV electron beam due to the use of a thinner custom scattering foil to reduce the degradation of the ultra-high dose rate. The depth-dose curve beyond the build-up region for the FLASH beam was similar to the conventional 16 MeV electron beam for which the range at 50% the maximum dose (R50) agreed within 0.5 mm. The FLASH beam output remained consistent over a 4-month period with a variation of 2.5%, on average. The FLASH sparing effect was observed in vitro for healthy human pancreatic cells. Furthermore, we observed that the highest PRF beam (180 pulses/s) was more effective at destroying pancreatic cancerous cells while minimizing damage to healthy cells compared to the lowest PRF beam (18 pulses/s). The novel commercial FLASH Research Extension system was dosimetrically characterized for pre-clinical FLASH research, and preliminary in vitro results demonstrated the FLASH effect. Given the prevalence of linear accelerators, this new commercial system has the potential to greatly increase the access to FLASH research.

A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial.

Suicide attempts and suicide death disproportionately affect sexual and gender minority emerging adults (age 18-24 years). However, suicide prevention strategies tailored for emerging adult sexual and gender minority (EA-SGM) groups are not widely available. The Safety Planning Intervention (SPI) has strong evidence for reducing the risk for suicide in the general population, but it is unclear how best to support EA-SGM groups in their use of a safety plan. Our intervention (Supporting Transitions to Adulthood and Reducing Suicide [STARS]) builds on content from an existing life skills mobile app for adolescent men who have sex with men (iREACH) and seeks to target core risk factors for suicide among EA-SGM groups, namely, positive affect, discrimination, and social disconnection. The mobile app is delivered to participants randomized to STARS alongside 6 peer mentoring sessions to support the use of the safety plan and other life skills from the app to ultimately reduce suicide risk. We will pilot-test the combination of peer mentoring alongside an app-based intervention (STARS) designed to reduce suicidal ideation and behaviors. STARS will include suicide prevention content and will target positive affect, discrimination, and social support. After an in-person SPI with a clinician, STARS users can access content and activities to increase their intention to use SPI and overcome obstacles to its use. EA-SGM groups will be randomized to receive either SPI alone or STARS and will be assessed for 6 months. Guided by the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework, we will recruit and enroll a racially and ethnically diverse sample of 60 EA-SGM individuals reporting past-month suicidal ideation. Using a type-1 effectiveness-implementation hybrid design, participants will be randomized to receive SPI (control arm) or to receive SPI alongside STARS (intervention arm). We will follow the participants for 6 months, with evaluations at 2, 4, and 6 months. Preliminary effectiveness outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (positive affect, coping with discrimination, and social support) will serve as our primary outcomes. Secondary outcomes include key implementation indicators, including participants' willingness and adoption of SPI and STARS and staff's experiences with delivering the program. Study activities began in September 2021 and are ongoing. The study was approved by the institutional review board of the University of Pennsylvania (protocol number 849500). Study recruitment began on October 14, 2022. This project will be among the first tailored, mobile-based interventions for EA-SGM groups at risk for suicide. This project is responsive to the documented gaps for this population: approaches that address chosen family, focus on a life-course perspective, web approaches, and focus on health equity and provision of additional services relevant to sexual and gender minority youth. ClinicalTrials.gov NCT05018143; https://classic.clinicaltrials.gov/ct2/show/NCT05018143. DERR1-10.2196/48177.

A pilot study of stereotactic body radiotherapy combined with pelvic radiotherapy and GTVp boost based on multiparameter magnetic resonance image in patients with high-risk prostate cancer.

This pilot study aimed to explore the preliminary effects and safety of stereotactic body radiotherapy (SBRT) combined with preventive pelvic radiotherapy and primary gross tumor volumes (GTVp) boost in patients with high-risk prostate cancer based on multiparameter magnetic resonance image (mpMRI). Tumors were contoured as GTVp based on mpMRI. The prostate and proximal seminal vesicles were considered as the clinical target volume1. The pelvic lymphatic drainage area constituted clinical target volume 2. Radiation doses were 40Gy or 45Gy/5fractions to planning target volume of primary tumor, 37.5Gy/5f to prostate, seminal vesicle, and positive pelvic lymph nodes, and 25Gy/5f to pelvic synchronously. The treatment was delivered 3 times per week. Volumetric modulated arc radiotherapy and intensity-modulated radiotherapy were used to complete SBRT. The genitourinary (GU) and gastrointestinal (GI) toxicities were evaluated. Quality of life data was also captured. A total of 15 patients were enrolled in this study with a median age of 78 (56-87) from 2017 to 2020. All patients received SBRT. At 3 months after radiotherapy, the proportion of PSA < 0.006 ng/mL was 66.7% (10/15). The 2-year biochemical relapse-free survival was 93.3%. The incidence of grade 1 acute GU side effects was 80% (12/15); the incidence of acute grade 1 GI toxicity was 66.7% (10/15); and no grade 2 or higher acute GU and GI side effects was observed. Two patients presented with temporary late grade 2 GI toxicity. International Prostatic System Score increased rapidly after a transient increase at 1 week (P = .001). There were no significant differences in EORTC quality of life scores in all domains except global health status. In this pilot study, it was revealed that SBRT combined with preventive pelvic radiotherapy and GTVp boost based on mpMRI image was effective and well tolerated for patients with high-risk prostate cancer.