Pilot Randomized Controlled Trial Research Articles

Clinical benefits of self-guided mindfulness coach mobile app use for veterans with posttraumatic stress disorder: A pilot randomized control trial.

Mindfulness training can relieve posttraumatic stress disorder (PTSD) symptoms in military veterans and others but is inconsistently accessible. Self-guided mobile apps could improve access but their acceptability, feasibility, and benefits for veterans with PTSD have not been established. We conducted a pilot randomized trial of Mindfulness Coach (MC), a free, publicly available, trauma-informed mobile app tailored to veterans. U.S. veterans with PTSD (n = 173) were randomized to self-guided use of MC or waitlist control (WLC) with 8-week follow-up. Clinical outcomes were PTSD symptoms (PTSD Symptom Checklist-5), depression symptoms (Patient Health Questionnaire, nine item), and psychosocial functioning (Brief Inventory of Psychosocial Functioning). Primary analyses were intent-to-treat using linear mixed models with maximum likelihood estimation. App uptake, objective usage, and usability ratings measured acceptance and feasibility. Participants varied in age, gender, and ethnoracial identity; most reported recent mental health care utilization. Although study attrition was high (68.4% overall) due to participant dropout (treatment: 43.0%; control: 43.7%) and technical study issues (23% overall), diagnostic tests showed no evidence of bias due to missingness. Study completers (MC: n = 19; WLC: n = 37) showed medium effects on PTSD symptoms (b = -9.31, d = -0.69) and depression (b = -3.10, d = -0.52). Higher-intensity users showed greater benefits. App engagement trended lower for women and minoritized subpopulations. No changes were observed in psychosocial functioning. Usability and helpfulness ratings were favorable. Transdiagnostic clinical benefits indicate promise for MC as a public health resource for veterans with PTSD. Further study is warranted to confirm these benefits and ensure consistent engagement across subpopulations. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Feasibility and acceptability of a personalized, pre-filled online grocery cart to improve benefit redemption and diet quality of grocery purchases among participants of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Most participants in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) do not fully redeem their benefits due to barriers like transportation, confusing product eligibility, and unclear labeling. Online food shopping enables choice architecture to promote benefit redemption and maximize diet quality. We conducted a mixed-methods pilot randomized-controlled trial to assess the feasibility and acceptability of a pre-filled online grocery shopping cart to improve WIC benefit redemption and diet quality of grocery purchases. Rhode Island WIC participants (n = 24, mean age 29.4 ± 1.1 years, 75% Hispanic, 54% had never grocery shopped online) completed a baseline questionnaire and a simulated shopping episode (SSE), buying WIC and non-WIC items. After a week, we randomized participants into the intervention (personalized, modifiable carts pre-filled with 100% of the 2022 proposed WIC packages) or control (selected their items individually) groups before the second SSE. Both groups had WIC labels. We assessed feasibility using process data and percent agreement to feasibility questions, and acceptability via percent agreement to acceptability questions and post-intervention qualitative interviews. We conducted exploratory analyses to examine differences within and between groups at each timepoint for percent WIC benefit redemption and diet quality of grocery purchases, evaluated using the Grocery Purchase Quality Index-2016 (GPQI-2016) scores. Quantitative study measures suggest that the intervention was feasible and that the personalized, modifiable pre-filled cart was acceptable. These findings were supported during qualitative interviews, where participants highlighted time-savings, flexibility, and WIC labels as facilitators of WIC online shopping. Exploratory results showed significant increases in mean percent redemption of most WIC food categories and non-significant moderate increases in most GPQI-2016 scores. These measures are vital for the future adaptation of a full-scale efficacy trial in real-life settings.

Protocol for an intervention for new parents experiencing moderate psychosocial adversity: pilot feasibility randomised trial

ABSTRACT Background Parents exposed to psychosocial adversities often experience challenges which, combined with the needs of a new-born infant, can be difficult to manage and increase the risk of poor outcomes for both parents and infants. Psychosocial adversity can disrupt the development of parental-foetal attachment to the baby during pregnancy, which can have a negative effect on parental care and quality of interaction during the postnatal period. This intervention is based on the proposition that enhanced parental capacity to mentalise and emotionally connect to unborn children during pregnancy, and better understanding about how to manage distressing infant behaviour (i.e., persistent crying and sleep problems) will: (i) promote the development of secure parent-infant attachment; (ii) improve antenatal bonding and postnatal parenting; and, (ii) reduce parental distress. Method This protocol is for a pilot randomised control trial evaluating a new intervention, which makes use of innovative technologies to support parents experiencing moderate psychosocial adversity (Australian New Zealand Clinical Trials Registry: ACTRN12622000287730). The New Technology for New Parents (NTNP) intervention provides support using antenatal ultrasound scans and ‘virtual home visits’ during the perinatal period. Quantitative outcomes include mentalising capacity, parental-foetal/infant attachment, and parental competence. Conclusion To the best of our knowledge, no study has evaluated the combined effectiveness of two novel technologies (3D/4D ultrasound scans and virtual home visits) to support parents across the antenatal and postnatal periods. This protocol, which includes the rationale for this innovative intervention, addresses a gap in services for parents experiencing moderate psychosocial adversity.

Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial.

Deep dyspareunia affects 50% of people with endometriosis. The Ohnut is a set of interlocking rings that fit over the penis/insertive object. One or more rings can be used to limit insertion depth and reduce deep dyspareunia. We conducted a pilot, parallel, open-label randomized controlled trial (RCT) to investigate the feasibility of the study design and the acceptability and preliminary efficacy of the Ohnut. Participants were recruited from a tertiary center for endometriosis. Eligibility criteria were surgically confirmed endometriosis, age 19-49years, monogamous sexual relationship with a partner willing to participate in the study, and no comorbid superficial dyspareunia, anxiety, or depression. Couples were randomized into an intervention group or a waitlist control group using a 1:1 allocation ratio. All couples had sex as normal during weeks 1 to 4 (baseline period), and couples in the intervention group used the Ohnut with sex during weeks 5 to 10 (intervention period) while controls had sex as normal. Patient participants used daily diaries to record sexual activity and deep dyspareunia score (0-10) for the 10-week study. Intervention group participants completed an acceptability questionnaire at the end of the study. The primary outcomes were feasibility of the study and acceptability of the Ohnut. We also assessed differences in deep dyspareunia scores in the participants who used the Ohnut compared to the control participants who did not. We recruited approximately 5 couples per month of active recruitment. Of 864 potentially eligible participants, we successfully contacted 44.7% (n = 386), of whom 8.0% (n = 31) consented, 64.8% (n = 250) were ineligible, and 27.2% (n = 105) declined. Thirty-one couples were randomly assigned to the intervention or control group, and 17 couples completed the study. Intervention group couples used the Ohnut for an average of 72.4% (32.7%) of sexual encounters during the intervention period. The mean acceptability index score for the Ohnut was 0.83 (0.078) among patients and 0.83 (0.049) among partners (index between 0 and 1). After controlling for baseline deep dyspareunia, there was a significant difference in the intervention period mean deep dyspareunia scores between the control and intervention group (4.69 (2.44) vs 2.46 (1.82), P = .012). We identified preliminary evidence for the acceptability and efficacy of the Ohnut among both patients and partners, suggesting that the Ohnut may be a useful stand-alone or adjuvant management tool for endometriosis-associated deep dyspareunia. Strengths of this study were the "real-world" use of the Ohnut and data collection from both patients and partners. Limitations of the study design included the strict eligibility criteria that affected feasibility and generalizability. This pilot RCT indicated that the Ohnut may be an acceptable and effective intervention to reduce endometriosis-associated deep dyspareunia. We identified opportunities to improve design for a larger RCT. This clinical trial was registered with clinicaltrials.gov (#NCT04370444).

Long COVID Brain Fog Treatment: Findings from a Pilot Randomized Controlled Trial of Constraint-Induced Cognitive Therapy.

Long COVID brain fog is often disabling. Yet, no empirically-supported treatments exist. This study's objectives were to evaluate feasibility and efficacy, provisionally, of a new rehabilitation approach, Constraint-Induced Cognitive Therapy (CICT), for post-COVID-19 cognitive sequelae. Sixteen community-residents ≥ 3-months post-COVID-19 infection with mild cognitive impairment and dysfunction in instrumental activities of daily living (IADL) were enrolled. Participants were randomized to Immediate-CICT or treatment-as-usual (TAU) with crossover to CICT. CICT combined behavior change techniques modified from Constraint-Induced Movement Therapy with Speed of Processing Training, a computerized cognitive-training program. CICT was deemed feasible if (a) ≥80% of participants completed treatment, (b) the same found treatment highly satisfying and at most moderately difficult, and (c) <2 study-related, serious adverse-events occurred. The primary outcome was IADL performance in daily life (Canadian Occupational Performance Measure). Employment status and brain fog (Mental Clutter Scale) were also assessed. Fourteen completed Immediate-CICT (n=7) or TAU (n=7); two withdrew from TAU before their second testing session. Completers were [M (SD)]: 10 (7) months post-COVID; 51 (13) years old; 10 females, 4 males; 1 African American, 13 European American. All the feasibility benchmarks were met. Immediate-CICT, relative to TAU, produced very large improvements in IADL performance (M=3.7 points, p<.001, d=2.6) and brain fog (M=-4 points, p<.001, d=-2.9). Four of five non-retired Immediate-CICT participants returned-to-work post-treatment; no TAU participants did, p=.048. CICT has promise for reducing brain fog, improving IADL, and promoting returning-to-work in adults with Long COVID. Findings warrant a large-scale RCT with an active-comparison group.

Protective Assets Reinforced With Integrated Care and Technology (PARITY): Protocol for a Randomized Controlled Trial.

Black women are significantly more likely to experience severe maternal morbidity and are 3 times as likely to die from pregnancy-related causes compared to White women. Using a strengths-based wellness approach within an integrated supportive care program provided by a community doula could offer pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational SMS text messages, as well as community-based doula support delivered both in person and through the technology platform to improve Black maternal wellness. This pilot randomized controlled trial (RCT) and mixed methods evaluation aims to (1) determine the feasibility and acceptability of the PARITY intervention; (2) investigate the preliminary efficacy of the PARITY intervention on clinical outcomes (maternal blood pressure, gestational weight gain, and cesarean birth); and (3) investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and health care adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group compared to a control group. A 2-arm RCT and mixed methods evaluation will be conducted. Overall, 60 Black pregnant individuals will be randomized in a ratio of 1:1 to either the intervention or informational control group. Participants in the intervention group will receive access to the technology platform over a 12-week period that ends before birth. Intervention participants will be assigned a doula interventionist, who will meet with them 4 times during the intervention. All participants (intervention and control) will receive a referral for a birth doula at no cost, printed materials about having a healthy pregnancy, and community resources. Feasibility and acceptability will be assessed at the end of the program. Measures will be obtained at baseline (20-28 weeks), the 36th week of pregnancy, birth, and 6-12 weeks post partum. Summary statistics and distribution plots will be used to describe measured variables at each time point. A generalized linear mixed model with a shared random component will be used to analyze the effects of PARITY on clinical, wellness behavioral, and empowered strength outcomes, including baseline nutrition, physical activity, and sleep measures as covariates. For significant effects, post hoc contrasts will be adjusted using the Holm method to maintain comparison-wise error at or <.05. Missing data will be addressed using a pattern-mixture model. The National Institute of Nursing Research funded this pilot RCT. Recruitment, enrollment, and data collection are ongoing, and the estimated study completion date is October 2024. The expected results of this study will provide the feasibility and preliminary efficacy of the PARITY intervention, to be used in a larger trial with a 12-month PARITY program intervention. ClinicalTrials.gov NCT05802615; https://clinicaltrials.gov/study/NCT05802615. DERR1-10.2196/58580.

Effects of a Brief Self-Compassion Online Intervention on Complex Posttraumatic Stress Symptoms Among Chinese University Students With Trauma History: A Pilot Randomized Controlled Trial

Purpose: The present study aimed to investigate the efficacy of a brief 10-day online self-compassion intervention, lasting around 25 min per day, in reducing complex posttraumatic stress disorder (CPTSD) symptoms among university students with trauma history. Method: We adopted a 2 (intervention group vs. control group) × 3 (pre-test vs. post-test vs. one-month follow-up) randomized controlled trial (RCT) design. Results: Seventy-seven participants completed the study; repeated measures analysis of variance revealed a reduction in total CPTSD scores post-intervention. There was medium effect size of the intervention on disturbances in self-organization symptoms. Network analysis of CPTSD symptom changes and intervention conditions showed that changes in avoidance of external trauma cues, worthlessness, emotion dysregulation, feelings of isolation, and nightmare symptoms were directly associated with the intervention condition. Conclusions: The pilot RCT suggests the feasibility and potential effectiveness of the online self-compassion intervention for CPTSD symptoms among university students.

Brain-computer interface on wrist training with or without neurofeedback in subacute stroke: a study protocol for a double-blinded, randomized control pilot trial.

After a stroke, damage to the part of the brain that controls movement results in the loss of motor function. Brain-computer interface (BCI)-based stroke rehabilitation involves patients imagining movement without physically moving while the system measures the perceptual-motor rhythm in the motor cortex. Visual feedback through virtual reality and functional electrical stimulation is provided simultaneously. The superiority of real BCI over sham BCI in the subacute phase of stroke remains unclear. Therefore, we aim to compare the effects of real and sham BCI on motor function and brain activity among patients with subacute stroke with weak wrist extensor strength. This is a double-blinded randomized controlled trial. Patients with stroke will be categorized into real BCI and sham BCI groups. The BCI task involves wrist extension for 60 min/day, 5 times/week for 4 weeks. Twenty sessions will be conducted. The evaluation will be conducted four times, as follows: before the intervention, 2 weeks after the start of the intervention, immediately after the intervention, and 4 weeks after the intervention. The assessments include a clinical evaluation, electroencephalography, and electromyography using motor-evoked potentials. Patients will be categorized into two groups, as follows: those who will be receiving neurofeedback and those who will not receive this feedback during the BCI rehabilitation training. We will examine the importance of motor imaging feedback, and the effect of patients' continuous participation in the training rather than their being passive.Clinical Trial Registration: KCT0008589.

Examining the Complexities of Conducting Randomized Controlled Trials in Child Welfare Settings

ABSTRACT Background Randomized controlled trials (RCTs) are considered the gold standard for assessing the effectiveness of interventions. At the same time, it is challenging to evaluate interventions using experimental designs in child welfare settings. Objective This study explores the facilitators and challenges faced when carrying out a pilot RCT of a home-visitation intervention, Family Partner, that was implemented within Norwegian child welfare services. Method This study draws on 29 qualitative in-depth interviews and four focus group interviews that were carried out with child welfare workers, managers and stakeholders. Results Results revealed one facilitator and four challenges with carrying out RCTs in child welfare settings: The main facilitator was the staff’s belief in the intervention, while the challenges were 1) ethical concerns in participant recruitment and information sharing, 2) resource management challenges in randomization, 3) emotional strains in response to randomization, and 4) contamination between the intervention and control participants. Conclusion While we present possible solutions to the challenges, our results also highlight the importance of careful planning, preparation, piloting, and using mixed method research approaches when conducting RCTs within child welfare services.

The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial

The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-based peer group mobile messaging smoking cessation intervention. This study aims to assess the feasibility, acceptability, and preliminary effects of WeChat Quit Coach. We enrolled a total of 60 Chinese immigrant smokers in 2022 in New York City for a pilot randomized controlled trial (RCT) and a single-arm pilot test. The first 40 participants were randomized to either the intervention arm (WeChat Quit Coach) or the control arm (self-help print material) using 1:1 block randomization stratified by sex. WeChat Quit Coach lasted 6 weeks, featuring small peer groups moderated by a coach, daily text messages with text questions, and chat-based instant messaging support from the coach in response to peer questions. The next 20 participants were enrolled in the single-arm pilot test to further assess intervention feasibility and acceptability. All 60 participants were offered a 4-week supply of complimentary nicotine replacement therapy. Surveys were administered at baseline and 6 weeks, with participants in the pilot RCT completing an additional survey at 6 months and biochemical verification of abstinence at both follow-ups. Of 74 individuals screened, 68 (92%) were eligible and 60 (88%) were enrolled. The majority of participants, with a mean age of 42.5 (SD 13.8) years, were male (49/60, 82%) and not ready to quit, with 70% (42/60) in the precontemplation or contemplation stage at the time of enrollment. The pilot RCT had follow-up rates of 98% (39/40) at 6 weeks and 93% (37/40) at 6 months, while the single-arm test achieved 100% follow-up at 6 weeks. On average, participants responded to daily text questions for 25.1 days over the 42-day intervention period and 23% (9/40) used the chat-based instant messaging support. Most participants were satisfied with WeChat Quit Coach (36/39, 92%) and would recommend it to others (32/39, 82%). At 6 months, self-reported 7-day point prevalence abstinence rates were 25% (5/20) in the intervention arm and 15% (3/20) in the control arm, with biochemically verified abstinence rates of 25% (5/20) and 5% (1/20), respectively. WeChat Quit Coach was feasible and well-received by Chinese immigrants who smoke and produced promising effects on abstinence. Large trials are warranted to assess its efficacy in promoting abstinence in this underserved population. ClinicalTrials.gov NCT05130788; https://clinicaltrials.gov/study/NCT05130788.

A Pilot Randomized Control Trial of the Striving Towards EmPowerment and Medication Adherence (STEP-AD) Intervention for Black Women Living with HIV

Black women living with HIV (BWLWH) face adversities associated with lower HIV medication adherence, viral non-suppression, and mental health symptoms (e.g., post-traumatic stress disorder) such as trauma/violence, racism, HIV-related discrimination/stigma, and gender-related stressors. We developed the first intervention based in cognitive behavioral therapy and culturally congruent coping for BWLWH to increase medication adherence and decrease PTSD symptoms by enhancing resilience, self-care, engagement in care, and coping for trauma, racism, HIV-related discrimination/stigma, and gender-related stressors. A pilot randomized control trial was conducted with BWLWH and histories of trauma who were at risk for their HIV viral load remaining or becoming detectable (i.e., below 80% medication adherence, detectable viral load in the past year, and/or missed HIV-related appointments). 119 BWLWH were assessed at baseline and 70 met inclusion criteria, completed one session of Life-Steps adherence counseling, and were randomized to either nine sessions of STEP-AD (Striving Towards EmPowerment and Medication Adherence) or ETAU (enhanced treatment as usual consisting of biweekly check-ins). Women completed a post intervention follow up assessment (3 months post baseline) and 3-month post intervention follow-up (6 months post baseline). Via STATA the difference-in-difference methodology with mixed models compared STEP-AD to ETAU on changes in outcomes over time. BWLWH in STEP-AD compared to E-TAU had significantly higher ART adherence (estimate = 9.36 p = 0.045) and lower likelihood of being clinically diagnosed with PTSD (OR = .07, estimate = − 2.66, p = 0.03) as well as borderline significance on higher CD4 count (estimate = 161.26, p = 0.05). Our findings suggest preliminary efficacy of STEP-AD in improving ART adherence, mental health, and immune function.

Tibial nerve stimulation in the management of primary sexual dysfunction in patients with multiple sclerosis: a pilot randomized control trial.

Sexual dysfunction (SD) is a common symptom that affects 40-90% of patients with multiple sclerosis (MS). Previous studies have highlighted the negative impact of sexual dysfunction in the mental health status and overall quality of life in patients with MS. The aim of this study was to examine the effects of transcutaneous tibial nerve stimulation (TTNS) in the primary SD symptoms in patients with MS. A total of 40 participants were randomized (1:1 ratio) to either TTNS or Sham group and received three 20min sessions over the course of two months. Pre and post intervention SD was evaluated using the Multiple Sclerosis Intimacy Questionnaire (MISQ-15). Statistically significant improvements in the aspects of primary sexual dysfunction were observed in the TTNS group pre-post intervention (specifically erectile function (for males)/vaginal lubrication (for females) (p < .001), orgasm quality and satisfaction for both male and female patients (p < .001), sexual desire (p < .05) and bladder related symptomatology (p < .005). In the sham group pre-post intervention, the only observed improvement was in the sexual desire aspect (p < .05). Post intervention the groups significantly differed erectile function/vaginal lubrication and orgasm quality and satisfaction (p < .05). Our findings underline the efficacy of TTNS in improving primary SD symptoms as well as bladder problems in both male and female patients with MS. TTNS demonstrated significant improvement in the following domains: erectile function, vaginal lubrication, orgasm quality, satisfaction, bladder-related symptoms, and sexual desire.

Effectiveness of Culinary Nutrition Workshops on the Mood and Nutritional Interest of Inpatients With Mental Disorder.

Background Promoting healthy eating habits through nutrition education programs is crucial to improving the overall healthof people with mental disorders. This study aims to assess the effectiveness of culinary nutrition workshops on the mood and nutritional interest of hospitalized adults with mental disorders (MD)from the acute psychiatric unit of two general hospitals in Catalonia, Spain. Methods A pilot randomized control trial (RCT) was conducted with MD inpatient. Participants were randomly assigned to two groups: the intervention group receivedweekly culinary nutrition workshops with flexible participation andthe control group continued routinary care. The interest in nutrition was analysed with an ad hoc item pre and post-intervention period. Mood changes were studied with a visual analog scale and analysed pre- and post-intervention periods as well as before and after every session.An ad hoc questionnaire was also used to assess the satisfaction of participants with the intervention. The obtained data were analysed at both descriptive and inferential levels. Results We included 81 participants, with a mean age of 45.3 (SD: 17.0); 66.7% were women, with 41 assigned to the intervention group and 40 to the control group. At the end of every culinary nutrition workshop, a statistically significant improvement in mood was observed in the intervention group (5.9 vs. 7.4 points, p<0.001).However, there were no significant differences in mood changes between the control and intervention groups after the intervention period (control group: 1.0 vs. intervention group: 1.5, p=0.473), while the nutritional interest was significantly improved after the intervention period intergroups (control group: 4.1 vs. intervention group: 37.2, p<0.001). The intervention was excellently valued by the participants regarding content, space, and health professionals, and generated interest and motivation, with scores above 9 on all these items. Conclusion The improvement of interest in nutrition and the satisfaction of hospitalised people with MD with the nutrition culinary workshops emphasizethe need to design more comprehensive RCTs in hospitals and rehabilitation centers.

Feasibility and preliminary efficacy of an online nutrition education intervention for those with a sleeve gastrectomy: A pilot randomised control trial.

A sleeve gastrectomy (SG) is a lifelong treatment that improves health and better outcomes are associated with follow-up. However, there is lack of access or high attrition to aftercare. This potentially contributes to sub-optimal dietary intake and a lack of evidence for nutrition interventions. The present study assessed the feasibility and preliminary efficacy of a nutrition intervention to improve diet quality in Australian adults living with a SG. Adults (n = 96) post-SG were recruited into a cross-sectional diet quality study, with 68 eligible for randomisation to an intervention or wait-list control group. Over 10 weeks, a Facebook group was used to post daily nutrition education. Feasibility outcomes included participant recruitment, engagement, retention and acceptability. Preliminary efficacy was assessed using change in Australian Recommended Food Score (ARFS). Linear mixed models were used to measure differences in mean outcome between the experimental groups over time. Sixty-eight participants (97% female) aged 48.2 ± 9.8 years, body mass index 33.1 ± 5.8 kg/m2, and mean ± SD ARFS 39 ± 9 points were randomised to the intervention, with 66% retention at 10 weeks. At follow-up, diet quality increased for the intervention group (mean ARFS, 95% confidence interval = 0.2 [-1.5 to 1.9]) and decreased for the control group (mean ARFS, 95% confidence interval= -2.0 [-5.2 to 1.2]) with no between group difference (p = 0.2). Participants (n = 30) rated the intervention positively. Recruiting and retaining adults post-SG into a nutrition intervention is feasible. Low-cost recruitment attracted strong interest from women to identify greater support to know what to eat following SG. A future fully powered trial to assess intervention efficacy is warranted.

Switching to e-cigarettes as harm reduction among individuals with chronic disease who currently smoke: Results of a pilot randomized controlled trial.

E-cigarettes (ECs) may be an effective harm reduction strategy for individuals with conditions like chronic obstructive pulmonary disease (COPD), asthma, coronary artery disease (CAD), and peripheral arterial disease (PAD) who smoke combustible cigarettes (CCs). Our aim was to examine how individuals with chronic conditions transition from CCs to ECs and its impact on health outcomes. In a pilot randomized controlled trial (RCT), patients with COPD, asthma, CAD/PAD who currently smoke CCs and have not used nicotine replacement therapy (NRT) or ECs in the past 14 days were randomized to receive ECs or combination NRT with behavioral counselling. Disease symptoms, acceptability/satisfaction (TSQM-9) and feasibility, and cigarettes per day (CPD), and/or EC use were collected at baseline, 3-, and 6-months. Descriptive statistics and a linear regression were conducted to explore changes in CPD and chronic condition-specific assessments (CAT, SAQ-7, ACT) that assess COPD, asthma, and CAD/PAD symptom change. At 3-months, the EC group (n=63, mean CPD=9±11) reduced their CPD by 54% vs. 60% in the NRT group (n=58, mean CPD=7±6), p=0.56. At 6-months, 17.5% had switched completely to ECs while 23% quit smoking in the NRT arm. CAT scores showed a significant 6-point reduction in the EC arm (p=0.03). Participants scored an average of 69±27 for EC effectiveness, 87±23 for convenience, and 75±27 for overall satisfaction. This pilot study suggests that ECs may be a safer alternative for chronic condition patients using CCs and warrants further research on expected smoking cessation/reduction among individuals who use ECs. The findings from this pilot RCT hold significant implications with chronic conditions such as COPD, asthma, CAD and PAD who smoke CCs. The observed reduction in cigarettes per day and improvement in respiratory symptoms suggest that switching to ECs appears feasible and acceptable among those with chronic diseases. These results suggest that ECs may offer an alternative for individuals struggling to quit CC smoking through existing pharmacotherapies. This study supports further exploration of switching to ECs as a harm reduction strategy among CC users who have been unsuccessful at quitting by other means.

Effects of Brunnstrom movement therapy versus mirror therapy on hand function in post-stroke hemiplegic population

Objectives: The objective of this study was to compare the effects of Brunnstrom movement therapy and mirror therapy (MT) on hand function in the post-stroke hemiplegic population. Methods: This randomized control pilot trial was conducted at District Headquarters Hospital and Rafiqa Hospital Sargodah, Pakistan in 2022. A total of 26 stroke patients having spastic hands aged 40–70 were randomized into two groups. Group A was treated with Brunnstrom movement therapy along with conventional treatment. Group B was treated with MT and conventional treatment. Fugl-Meyer assessment: wrist and hand subtest (items VII, VIII, and IX) and Brunnstrom hand manipulation were used to assess outcome measures. Results: Twenty-six patients of both sexes, 13 in each group. The mean age in Group A was 58.30 ± 7.53, and Group B’s was 57.46 ± 8.40. Brunnstrom movement and MT scores showed a statistically significant difference within a group (P &lt; 0.05). The between-group comparison showed a statistically significant difference (P &lt; 0.05). Between-group comparison of results showed marked improvement in Fugl-Meyer in the case of Brunnstrom movement therapy compared to MT. Conclusion: This study concluded that stroke patients treated with Brunnstrom movement therapy showed more improvement in hand functioning and activities of daily living than those treated with MT.

Safety and adherence to medications and self-care advice in oncology (SAMSON): pilot randomised controlled trial protocol

IntroductionWith the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments’ efficacy and toxicity is drawing more attention....

Intervention-Induced Changes in Balance and Task-Dependent Neural Activity in Adults with Acquired Brain Injury: A Pilot Randomized Control Trial.

Advances in neuroimaging technology, like functional near-infrared spectroscopy (fNIRS), support the evaluation of task-dependent brain activity during functional tasks, like balance, in healthy and clinical populations. To date, there have been no studies examining how interventions, like yoga, impact task-dependent brain activity in adults with chronic acquired brain injury (ABI). This pilot study compared eight weeks of group yoga (active) to group exercise (control) on balance and task-dependent neural activity outcomes. Twenty-three participants were randomized to yoga (n = 13) or exercise groups (n = 10). Neuroimaging and balance performance data were collected simultaneously using a force plate and mobile fNIRS device before and after interventions. Linear mixed-effects models were used to evaluate the effect of time, time x group interactions, and simple (i.e., within-group) effects. Regardless of group, all participants had significant balance improvements after the interventions. Additionally, regardless of group, there were significant changes in task-dependent neural activity, as well as distinct changes in neural activity within each group. In summary, using advances in sensor technology, we were able to demonstrate preliminary evidence of intervention-induced changes in balance and neural activity in adults with ABI. These preliminary results may provide an important foundation for future neurorehabilitation studies that leverage neuroimaging methods, like fNIRS.

A Pilot Randomized-Controlled Trial of Sleep Scholar: A Brief, Internet-Based Insomnia Intervention for College Students

This randomized-controlled trial examined the efficacy of Sleep Scholar, a brief, internet-based insomnia intervention tailored to the needs of college students. College students commonly experience insomnia and various other mental health symptoms, including suicide ideation. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a promising suicide prevention effort for college students because insomnia is robust risk factor for suicide ideation and CBT-I reduces suicide ideation. Moreover, CBT-I can be brief, self-guided, and internet-based. CBT-I also may elicit less stigma than treatment specifically targeting suicide ideation. However, existing forms of brief CBT-I are neither self-guided nor internet-based, and existing forms of self-guided, internet-based CBT-I are not brief. In addition, previous iterations of CBT-I are not typically designed to address the unique sleep needs of college students. For this registered clinical trial, we recruited 61 college students with at least subclinical insomnia symptoms. Participants were randomized to either Sleep Scholar or a control condition, Building Healthy Habits. Participants completed pretreatment daily sleep diaries and surveys, a posttreatment assessment of acceptability and satisfaction, a 1-week and 1-month survey follow-up, and daily sleep diaries throughout the 1-month follow-up period. Results showed that Sleep Scholar was more acceptable and satisfactory compared to the control condition at posttreatment. However, Sleep Scholar was not more effective for improving sleep or mental health symptoms compared to the control condition. These findings suggest that modifications to Sleep Scholar are needed to improve its efficacy.