Fire Needling Therapy versus Usual Care for Parkinson's Disease-Related Chronic Pain: A Pilot Randomized Controlled Trial.

Introduction: Parkinson's disease (PD)-related chronic pain is a prevalent non-motor symptom, this study aimed to detect the effect and safety of fire needling therapy (FNT) for PD-related chronic pain relief. Methods: Patients with PD-related chronic pain were randomly allocated to FNT group and control group with a treatment phase of 8 weeks and a follow-up phase of 4 weeks. Primary outcome was the King's Parkinson's Pain Scale (KPPS), Secondary outcomes included Visual Analogue Scale (VAS), Unified Parkinson's Disease Rating Scale-III (UPDRS-III), and the Parkinson's Disease Questionnaire-39 (PDQ-39). Study was registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2400084951). Results: 60 participants were randomized, with 30 in the FNT group and 30 in the control group. KPPS was significantly influenced by the interaction of treatment and time, with a significant reduction in pain observed in the FNT group compared to the control group at Week 4 (difference [95% CI]: -20.693[-27.619,-13.767], P<0.001), Week 8 (difference [95% CI]: 44.680[-52.359,-37.000], P<0.001), and Week 12 (difference [95% CI]: -44.982[-52.771,-37.193], P<0.001). For VAS, UPDRS-III, and PDQ-39, there were significant differences between groups at Week 4, Week 8, and Week 12. Conclusion: FNT could be an effective and safe method for managing PD-related chronic pain. However, large-sample studies conducted in multiple centers are necessary to further verify the findings in the future.

A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial.

Background: Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise. Methods: We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time. Discussion: The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs. Trial registration: ClinicalTrials.gov NCT05109507.

Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Efficacy of smartphone-based interventions depends on intervention content quality and level of exposure to that content. Smartphone-based survey completion rates tend to decline over time; however, few studies have identified variables that predict this decline over longer-term interventions (eg, 26 weeks). OBJECTIVE: This study aims to identify predictors of survey completion and message viewing over time within a 26-week smoking cessation trial. METHODS: This study examined data from a 3-group pilot randomized controlled trial of adults who smoke (N=152) and were not ready to quit smoking within the next 30 days. For 182 days, two intervention groups received smartphone-based morning and evening messages based on current readiness to quit smoking. The control group received 2 daily messages unrelated to smoking. All participants were prompted to complete 26 weekly smartphone-based surveys that assessed smoking behavior, quit attempts, and readiness to quit. Compliance was operationalized as percentages of weekly surveys completed and daily messages viewed. Linear regression and mixed-effects models were used to identify predictors (eg, intervention group, age, and sex) of weekly survey completion and daily message viewing and decline in compliance over time. RESULTS: The sample (mean age 50, SD 12.5, range 19-75 years; mean years of education 13.3, SD 1.6, range 10-20 years) was 67.8% (n=103) female, 74.3% (n=113) White, 77% (n=117) urban, and 52.6% (n=80) unemployed, and 61.2% (n=93) had mental health diagnoses. On average, participants completed 18.3 (71.8%) out of 25.5 prompted weekly surveys and viewed 207.3 (60.6%) out of 345.1 presented messages (31,503/52,460 total). Age was positively associated with overall weekly survey completion (P=.003) and daily message viewing (P=.02). Mixed-effects models indicated a decline in survey completion from 77% (114/148) in the first week of the intervention to 56% (84/150) in the last week of the intervention (P<.001), which was significantly moderated by age, sex, ethnicity, municipality (ie, rural/urban), and employment status. Similarly, message viewing declined from 72.3% (1533/2120) in the first week of the intervention to 44.6% (868/1946) in the last week of the intervention (P<.001). This decline in message viewing was significantly moderated by age, sex, municipality, employment status, and education. CONCLUSIONS: This study demonstrated the feasibility of a 26-week smartphone-based smoking cessation intervention. Study results identified subgroups that displayed accelerated rates in the decline of survey completion and message viewing. Future research should identify ways to maintain high levels of interaction with mobile health interventions that span long intervention periods, especially among subgroups that have demonstrated declining rates of intervention engagement over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129.

Culturally Sensitive Advance Care Planning for African American Advanced Cancer Patients: A Pilot Randomized Controlled Trial.

CONTEXT: Racial disparities in advance care planning (ACP) have been consistently identified in the literature. Few interventions have been designed to address the disparities identified. OBJECTIVES: To assess the feasibility, acceptability, and preliminary efficacy of a culturally sensitive, pilot ACP intervention for African American patients diagnosed with cancer in a safety net healthcare system. METHODS: Eligible patients with stage II, III, or IV breast, lung, colorectal, or prostate cancer were identified from the electronic health record, recruited, and randomized to the intervention group or usual care control group. Intervention participants met with an African American lay health advisor who assisted them in watching a video that addressed completion of ACP and facilitated ACP discussion. Descriptive analyses were conducted to examine baseline sociodemographic and clinical characteristics, cancer health literacy, and religious coping among participants. Logistic regression analyses were conducted to evaluate predictors of positive change in stage of intent to discuss ACP at 1, 3, and 6-months post intervention. RESULTS: Seventy-six participants were recruited and randomized (38 intervention, 38 controls). The mean age for participants was 58.8 years (SD 10.8), 62.5% were female, and 90.2% had stage III or IV disease. The intervention proved feasible with 89.5% completion. Intervention participants were more likely to have a positive change in stage of intent to discuss a living will or advance directive than usual care controls at one-month (AOR: 4.57, 95%CI: 1.11, 18.82) and 3-months (AOR: 5.38, 95%CI: 1.05, 27.68) post-intervention. The majority (94.1%) of intervention participants would recommend the intervention to a friend or family member. CONCLUSION: This culturally sensitive ACP program proved to be feasible, acceptable to participants, and showed some promise in promoting discussion about ACP among participants and members of their healthcare team.

A Pilot Randomized Controlled Trial of Intervention for Social Work Clients with Children Facing Complex Financial Problems in Finland (FinSoc): A Study Protocol.

PURPOSE: Social work clients often face complex financial problems. We have developed a financial social work intervention, FinSoc, to increase financial literacy and economic self-efficacy and reduce financial anxiety among parents with financial problems in Finland. The aim of this pilot randomized controlled trial is to explore the feasibility, acceptability, and preliminary effectiveness of the intervention. This paper, a study protocol, describes the design and implementation of the trial. Study protocols are articles detailing a priori the research plan, rationale, proposed methods and plans for how a clinical trial will be conducted. METHOD: This study is a pilot randomized controlled trial with a mixed methods approach applying both quantitative measures and qualitative interviews. Participating social work clients with children are randomly assigned to either the treatment or the waiting list control group at a ratio of 1:1. The treatment group receives the intervention and the control group receives services as usual. The quantitative data from social work clients are collected at three measurement points. Qualitative interviews are conducted post-intervention with both clients receiving, and professionals implementing the intervention. The feasibility is assessed through recruitment and retention rates and the interviews with social work professionals providing the intervention. Acceptability is assessed through feedback from participants on satisfaction with the intervention and usefulness of the specific intervention components. Potential effectiveness is measured by financial literacy, economic self-efficacy and financial anxiety. DISCUSSION: The intervention is hypothesized to increase financial literacy and economic self-efficacy and reduce financial anxiety among social work clients with children. The results of this pilot study will increase the evidence base of financial social work and offer new insights for developing interventions for clients experiencing financial difficulties.

A Digital Single-Session Intervention (Project Engage) to Address Fear of Negative Evaluation Among College Students: Pilot Randomized Controlled Trial.

BACKGROUND: Increasingly, college science courses are transitioning from a traditional lecture format to active learning because students learn more and fail less frequently when they engage in their learning through activities and discussions in class. Fear of negative evaluation (FNE), defined as a student's sense of dread associated with being unfavorably evaluated while participating in a social situation, discourages undergraduates from participating in small group discussions, whole class discussions, and conversing one-on-one with instructors. OBJECTIVE: This study aims to evaluate the acceptability of a novel digital single-session intervention and to assess the feasibility of implementing it in a large enrollment college science course taught in an active learning way. METHODS: To equip undergraduates with skills to cope with FNE and bolster their confidence, clinical psychologists and biology education researchers developed Project Engage, a digital, self-guided single-session intervention for college students. It teaches students strategies for coping with FNE to bolster their confidence. Project Engage provides biologically informed psychoeducation, uses interactive elements for engagement, and helps generate a personalized action plan. We conducted a 2-armed randomized controlled trial to evaluate the acceptability and the preliminary effectiveness of Project Engage compared with an active control condition that provides information on available resources on the college campus. RESULTS: In a study of 282 upper-level physiology students, participants randomized to complete Project Engage reported a greater increase in overall confidence in engaging in small group discussions (P=.01) and whole class discussions (P<.001), but not in one-on-one interactions with instructors (P=.05), from baseline to immediately after intervention outcomes, compared with participants in an active control condition. Project Engage received a good acceptability rating (1.22 on a scale of -2 to +2) and had a high completion rate (>97%). CONCLUSIONS: This study provides a foundation for a freely available, easily accessible intervention to bolster student confidence for contributing in class. TRIAL REGISTRATION: OSF Registries osf.io/4ca68 http://osf.io/4ca68.

A multi-modal intervention for managing the fatigue-sleep disturbance-depressed mood symptom cluster in breast cancer patients undergoing chemotherapy: A pilot study.

Objective: To examine the feasibility and acceptability of a multi-modal intervention for managing the cancer-related fatigue-sleep disturbance-depressed mood (F-S-D) symptom cluster in patients with breast cancer (BC) and receiving chemotherapy in Hong Kong, and the preliminary effects of such intervention on the occurrence of the F-S-D symptom cluster in these patients. Methods: This study was a single-blind randomized controlled trial. Patients with BC scheduled for chemotherapy were recruited. Intervention participants received a weekly nurse-led multi-modal intervention lasting 7 weeks. The feasibility parameters and adverse events were assessed using logbook records. Acceptability was evaluated using a program evaluation questionnaire. F-S-D symptoms and quality of life (QOL) were measured at baseline (T0), upon intervention completion (T1), and 3 months after intervention completion (T2). Generalized estimating equation analyses were used. Results: Fifty participants were enrolled. The eligibility and enrollment rates were 11% and 87.7%, respectively. The rate of adherence to the intervention was 96%. No adverse events were reported. All participants were satisfied with the intervention, which had significant effects in terms of reducing the occurrence of the F-S-D symptom cluster at T2 (P â€‹= â€‹0.035) and improving QOL at T1 and T2 (T1: P â€‹= â€‹0.035; T2: P â€‹= â€‹0.012). Conclusions: The multi-modal intervention is a feasible, acceptable, and safe intervention that demonstrated preliminary positive effects in managing the F-S-D symptom cluster and improving QOL in patients with BC and receiving chemotherapy in Hong Kong. This study provides key insights into F-S-D symptom cluster management in patients with BC. Trial registration: ChiCTR2100047819 (Chinese Clinical Trial Register).

A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). CONCLUSION: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. TRIAL REGISTRATION: ISRCTN10151805 , retrospectively registered 04/10/2019.

Process evaluation of a kindergarten-based intervention for obesity prevention in early childhood: the Toybox study Malaysia.

BACKGROUND: Toybox is a kindergarten-based intervention program that targets sedentary behavior, snacking and drinking habits, as well as promoting physical activity in an effort to improve healthy energy balance-related behaviors among children attending kindergartens in Malaysia. The pilot of this program was conducted as a randomized controlled trial (RCT) involving 837 children from 22 intervention kindergartens and 26 control kindergartens respectively. This paper outlines the process evaluation of this intervention. METHODS: We assessed five process indicators: recruitment, retention, dosage, fidelity, and satisfaction for the Toybox program. Data collection was conducted via teachers' monthly logbooks, post-intervention feedback through questionnaires, and focus group discussions (FGD) with teachers, parents, and children. Data were analyzed using quantitative and qualitative data analysis methods. RESULTS: A total of 1072 children were invited. Out of the 1001 children whose parents consented to join, only 837 completed the program (Retention rate: 88.4%). As high as 91% of the 44 teachers and their assistants engaged positively in one or more of the process evaluation data collection methods. In terms of dosage and fidelity, 76% of parents had received newsletters, tip cards, and posters at the appropriate times. All teachers and their assistants felt satisfied with the intervention program. However, they also mentioned some barriers to its implementation, including the lack of suitable indoor environments to conduct activities and the need to make kangaroo stories more interesting to captivate the children's attention. As for parents, 88% of them were satisfied with the family-based activities and enjoyed them. They also felt that the materials provided were easy to understand and managed to improve their knowledge. Lastly, the children showed positive behaviors in consuming more water, fruits, and vegetables. CONCLUSIONS: The Toybox program was deemed acceptable and feasible to implement by the parents and teachers. However, several factors need to be improved before it can be expanded and embedded as a routine practice across Malaysia.

Electrically assisted cycling for individuals with type 2 diabetes mellitus: a pilot randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM. METHODS: A parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential. RESULTS: Forty participants (Mage = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity. CONCLUSIONS: The study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements. TRIAL REGISTRATION: ISRCTN, ISRCTN67421464 . Registered 17/12/2018.

Comparing the Feasibility and Acceptability of a Virtual Human, Teletherapy, and an e-Manual in Delivering a Stress Management Intervention to Distressed Adult Women: Pilot Study.

BACKGROUND: Virtual humans (VHs), teletherapy, and self-guided e-manuals may increase the accessibility of psychological interventions. However, there is limited research on how these technologies compare in terms of their feasibility and acceptability in delivering stress management interventions. OBJECTIVE: We conducted a preliminary comparison of the feasibility and acceptability of a VH, teletherapy, and an e-manual at delivering 1 module of cognitive behavioral stress management (CBSM) to evaluate the feasibility of the trial methodology in preparation for a future randomized controlled trial (RCT). METHODS: A pilot RCT was conducted with a parallel, mixed design. A community sample of distressed adult women were randomly allocated to receive 1 session of CBSM involving training in cognitive and behavioral techniques by a VH, teletherapy, or an e-manual plus homework over 2 weeks. Data were collected on the feasibility of the intervention technologies (technical support and homework access), trial methods (recruitment methods, questionnaire completion, and methodological difficulty observations), intervention acceptability (intervention completion, self-report ratings, therapist rapport, and trust), and acceptability of the trial methods (self-report ratings and observations). Qualitative data in the form of written responses to open-ended questions were collected to enrich and clarify the findings on intervention acceptability. RESULTS: Overall, 38 participants' data were analyzed. A VH (n=12), teletherapy (n=12), and an e-manual (n=14) were found to be feasible and acceptable for delivering 1 session of CBSM to distressed adult women based on the overall quantitative and qualitative findings. Technical difficulties were minimal and did not affect intervention completion, and no significant differences were found between the conditions (P=.31). The methodology was feasible, although improvements were identified for a future trial. All conditions achieved good satisfaction and perceived engagement ratings, and no significant group differences were found (P>.40). Participants had similar willingness to recommend each technology (P=.64). There was a nonsignificant trend toward participants feeling more open to using the VH and e-manual from home than teletherapy (P=.10). Rapport (P<.001) and trust (P=.048) were greater with the human teletherapist than with the VH. The qualitative findings enriched the quantitative results by revealing the unique strengths and limitations of each technology that may have influenced acceptability. CONCLUSIONS: A VH, teletherapy, and a self-guided e-manual were found to be feasible and acceptable methods of delivering 1 session of a stress management intervention to a community sample of adult women. The technologies were found to have unique strengths and limitations that may affect which works best for whom and in what circumstances. Future research should test additional CBSM modules for delivery by these technologies and conduct a larger RCT to compare their feasibility, acceptability, and effectiveness when delivering a longer home-based stress management program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000859987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380114&isReview=true.

A Relationship-Focused HIV Prevention Intervention for Young Sexual Minority Men in the United States: A Pilot Randomized Controlled Trial of the We Prevent Intervention.

We Prevent is a virtual counseling intervention designed to improve communication as a mechanism for reducing HIV risk among young sexual minority men (SMM) in relationships. We evaluated the feasibility, acceptability, and preliminary efficacy of We Prevent in comparison to standard Counseling, Testing, and Referral among a national sample of 318 SMM ages 15-24 in a pilot randomized control trial. We found significant differences in condomless sex with outside partners; however, there were no differences in other sexual behaviors, sexual agreements, intimate partner violence (IPV), or communication between the conditions across the 9-month follow-ups. Stratified analyses found non-significant trends suggestive that We Prevent may reduce condomless sex for those ages 15-17 and for relationships over 1-year and may reduce IPV in relationships over 1-year. Though study retention was adequate, session attendance was low. Exit interviews participants reported benefits of We Prevent and provided insights into how to increase uptake.

Feasibility, Acceptability, and Preliminary Efficacy of A Cognitive-Emotional Intervention Program in Homebound Older Adults: A Pilot Randomized Controlled Trial.

OBJECTIVES: To conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI) among homebound older adults with mild cognitive impairment and depressive or anxious symptomatology. METHODS: Fifty-one participants were randomly assigned to the intervention group or to the wait-list control group and completed baseline and post-intervention assessments. Feasibility and acceptability were the primary outcomes. Secondary outcomes included changes in cognitive function, depressive and anxiety symptoms, subjective memory complaints, functional status, and quality of life. Intervention effects were assessed both at a group level (two-way mixed ANOVA) and at an individual level (Reliable Change Index). RESULTS: The HEPPI was a feasible and acceptable non-pharmacological intervention. Compared to the wait-list control group, the intervention group showed significant improvement in cognitive, emotional, and functional domains at post-intervention. Differences between groups in the distributions by clinical change categories were observed. CONCLUSIONS: Results provide evidence of the HEPPI's feasibility, acceptability, and preliminary efficacy in increasing the cognitive and functional performance of homebound older adults and reducing their psychological symptomatology. CLINICAL IMPLICATIONS: Home-delivered cognitive-emotional interventions may be a promising and acceptable mental health approach for homebound older adults, improving their cognitive and emotional functioning.

Manual Acupuncture at LI11, Local Points and Both for Knee Osteoarthritis: A Pilot Randomized Controlled Trial.

Objective: Knee osteoarthritis (KOA) is a common chronic degenerative joint disease, and acupuncture is an alternative therapy for KOA. This study aims to detect the effectiveness of acupuncture at LI11 in improving pain and function for KOA patients. Methods: A total of 108 patients with KOA were randomly allocated to Control Group (local points), Treatment Group A (LI11), and Treatment Group B (local points and LI11) with a treatment phase of 4 weeks and a follow-up phase of 4 weeks. Primary outcome was response rate. Secondary outcomes included Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and recurrence rate. Study was registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2000034926). Results: The response rate in Treatment Group A, Treatment Group B, and Control Group was 71.43%, 85.29%, and 51.53%, respectively, at Week 4, and Treatment Group B was significantly higher than Control Group (difference[98.3% CI]: 33.86[0.135,0.543], P = 0.003). Although no significant difference was found, Treatment Group A had a better response rate compared with Control Group (difference[98.3% CI]: 20.00 [-0.072, 0.472], P = 0.086). For VAS and WOMAC, there were significant differences within 3 groups at Week 4 compared with the baseline. There was a significant improvement in VAS scores and WOMAC function and pain subscales at Week 4 in Treatment Group B compared with Control Group and Treatment Group A. Conclusion: LI11 is an effective point for patients with KOA, and it could be a selection for young acupuncturists and acupuncturists who work in rural areas; however, large-sample studies are necessary to further verify results in the future.

A Web-Based, Mindful, and Compassionate Parenting Training for Mothers Experiencing Parenting Stress: Results from a Pilot Randomized Controlled Trial of the Mindful Moment Program.

Objectives: Mindful Moment is a self-guided, web-based, mindful, and compassionate parenting training for postpartum mothers who experience parenting stress. We aimed to assess Mindful Moment's feasibility, acceptability, and usability, and to gather preliminary evidence of its effectiveness in reducing parenting stress and outcomes such as mindful parenting, self-compassion, depressive symptoms, anxious symptoms, dispositional mindfulness, mother's perception of infant temperament, and mother-infant bonding. Methods: This pilot randomized controlled trial (RCT) was a two-arm trial and followed the CONSORT 2010, CONSORT-EHEALTH, and CONSORT-SPI 2018 extension guidelines. A total of 292 Portuguese mothers were randomly assigned to the intervention group (n = 146) or to the waiting list control group (n = 146) and completed baseline (T1) and postintervention (T2) self-reported assessments. Results: A total of 31 mothers (21.23%) completed the Mindful Moment intervention. Most mothers evaluated the program as good or excellent (90%), considered that Mindful Moment provided them the kind of help they expected or wanted (61%), were satisfied with the help provided by the program (74.6%), would recommend it to a friend in a similar situation (86.4%), and would use it again if needed (81.4%). Regarding the program's preliminary effectiveness, mothers in the intervention group presented a greater decrease in parenting stress, a greater increase in dispositional mindfulness, and a greater decrease in their perception of the difficult temperament of their infants from T1 to T2. Conclusions: This study provides preliminary evidence of the Mindful Moment's effectiveness and suggests that it is a feasible and acceptable program for postpartum mothers experiencing parenting stress. Further research is needed to confirm these results in a larger RCT. Trial Registration: ClinicalTrials.gov (NCT04892082).

Auditory rhythmical cueing to improve gait in community-dwelling stroke survivors (ACTIVATE): a pilot randomised controlled trial.

BACKGROUND: Gait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors. METHODS: A parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety. RESULTS: Between November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study. CONCLUSION: We believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown. TRIAL REGISTRATION: ISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

The Preliminary Efficacy of a Program to Facilitate Benefit Finding for People with Mental Illness: A Pilot Randomized Controlled Trial in Japan.

Benefit finding is a concept that refers to finding positive changes or benefits through negative experiences from stressful life events. The present study aimed to develop a new intervention program to facilitate benefit finding for people with mental illness and examine its feasibility and preliminary efficacy from pilot data. We hypothesized that participants who joined the group-based intervention program would show progress in benefit finding, personal recovery, and well-being, as well as alleviated psychiatric symptoms and functional impairment, compared to participants in the control group. The participants in the intervention group joined in a new program which focuses on (1) cognitive-behavioral stress management and (2) own experiences, including what was found or realized through their lives since the onset of mental illness. The program used a workbook comprised of eight 90-min sessions, with one held every week. Twenty-four were found eligible and provided informed consent to participate in the study. About 46% were males, and the average age was 42.5 years. Around 63% were diagnosed with schizophrenia. We did not find significant differences over time by groups. However, medium to large effects in each scale or at least one subscale (i.e., benefit finding, personal recovery, subjective well-being, and psychiatric symptoms and functional impairment) were observed. Future studies with more participants from various settings would be necessary to exactingly examine the effectiveness of the intervention program.

HIAYA CHAT study protocol: a randomized controlled trial of a health insurance education intervention for newly diagnosed adolescent and young adult cancer patients.

BACKGROUND: For adolescent and young adult (AYA) cancer patients aged 18 to 39 years, health insurance literacy is crucial for an effective use of the health care system. AYAs often face high out-of-pocket costs or have unmet health care needs due to costs. Improving health insurance literacy could help AYAs obtain appropriate and affordable health care. This protocol illustrates a randomized controlled trial testing a virtual health insurance education intervention among AYA patients. METHODS: This is a two-arm multisite randomized controlled trial. A total of 80 AYAs diagnosed with cancer in the Mountain West region will be allocated to either usual navigation care or tailored health insurance education intervention with a patient navigator that includes usual care. All participants will complete a baseline and follow-up survey 5 months apart. The primary outcomes are feasibility (number enrolled and number of sessions completed) and acceptability (5-point scale on survey measuring satisfaction of the intervention). The secondary outcomes are preliminary efficacy measured by the Health Insurance Literacy Measure and the COmprehensive Score for financial Toxicity. DISCUSSION: This trial makes a timely contribution to test the feasibility and acceptability of a virtual AYA-centered health insurance education program. TRIAL REGISTRATION: ClinicalTrials.gov NCT04448678. Registered on June 26, 2020.

Comparing the Effects of Short-Term Liuzijue Exercise and Core Stability Training on Balance Function in Patients Recovering From Stroke: A Pilot Randomized Controlled Trial.

AIMS: Liuzijue Qigong (LQG) exercise is a traditional Chinese exercise method in which breathing and pronunciation are combined with movement guidance. Breathing is closely related to balance, and LQG, as a special breathing exercise, can be applied to balance dysfunction after stroke. The purpose of this study was to observe the clinical effects of short-term LQG exercise on balance function in patients recovering from stroke. METHODS: Stroke patients were randomly divided into an Intervention Group (IG) (n = 80) and a Control Group (CG) (n = 80). The IG received conventional rehabilitation training plus LQG and the CG received conventional rehabilitation training plus Core Stability Training (CST). All patients received treatment once a day, 5 times a week for 2 weeks. The primary outcome was Berg Balance Scale (BBS). Secondary outcome measures were static standing and sitting balance with eyes open and closed, Fugl-Meyer Assessment (FMA), Maximum Phonation Time (MPT), Modified Barthel Index (MBI) and diaphragm thickness and mobility during quiet breath (QB) and deep breath (DB). RESULTS: Compared with the CG, the IG showed significant improvement in the BBS (10.55 ± 3.78 vs. 9.06 ± 4.50, P = 0.039), MPT (5.41 ± 4.70 vs. 5.89 ± 5.24, P = 0.001), MBI (12.88 ± 6.45 vs. 10.00 ± 4.84, P = 0.003), diaphragmatic mobility during QB (0.54 ± 0.73 vs. 0.33 ± 0.40, P = 0.01) and diaphragmatic mobility during DB (0.99 ± 1.32 vs. 0.52 ± 0.77, P = 0.003), Cop trajectory in the standing position with eyes open (-108.34 ± 108.60 vs. -89.00 ± 140.11, P = 0.034) and Cop area in the standing positions with eyes open (-143.79 ± 431.55 vs. -93.29 ± 223.15, P = 0.015), Cop trajectory in the seating position with eyes open (-19.95 ± 23.35 vs. -12.83 ± 26.64, P = 0.001) and Cop area in the seating position with eyes open (-15.83 ± 9.61 vs. -11.29 ± 9.17, P = 0.002). CONCLUSIONS: The short-term LQG combined with conventional rehabilitation training significantly improved the balance functions of stroke patients. It also improved static standing and sitting balance with the eyes open, diaphragm functions, maximum phonation time and the quality of daily life for stroke patients. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn/edit.aspx?pid=25313&htm=4, Identifier: ChiCTR1800014864.

Feasibility of deploying peer coaches to mentor frontline home health aides and promote mobility among individuals recovering from a stroke: pilot test of a randomized controlled trial.

BACKGROUND: Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as "peer coaches" to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures. METHODS: This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures. RESULTS: Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants. CONCLUSIONS: The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04840407 . Retrospectively registered on 9 April 2021.