Wait-list Group Research Articles

Effectiveness and Long-Term Effects of SER+ FELIZ(mente): A School-Based Mindfulness Program for Portuguese Elementary Students

School-based mindfulness programs (SBMPs) have gained global popularity. Yet, there is a need for more rigorous procedures to develop and assess them. This study aimed to address these limitations by examining the effectiveness of a Portuguese SBMP, called SER + FELIZ(mente). The final sample included 190 third and fourth-graders: 99 in the SBMP group and 91 in a wait-list group. Effects on attentional control, emotional regulation and wellbeing were examined in the short term (T2) and 6 months later (T3). We also tested the moderating role of age, gender, and baseline scores. Using a multilevel modeling approach, results showed a clear benefit of SBMP on emotional wellbeing at T2 but not T3. Despite SBMP students surpassing wait-list students in attentional control, cognitive reappraisal, and social wellbeing at T2, these effects were due to a levelling off among SBMP students, coupled with a decline among wait-list students from T1 to T2. These effects were moderated by age at T3. While universal improvements were limited, our SBMP seemed to have acted as a shield against school stressors (i.e., likely, test anxiety at T2). This opens a new avenue for research concerning the role of SBMPs in preventing (rather than repairing) mental-health issues in elementary students.

Implementation of a Technology-Enabled Diabetes Self-Management Peer Coaching Intervention for Patients With Poorly Controlled Diabetes: Quasi-Experimental Case Study.

Patients with diabetes experience worse health outcomes and greater health care expenditure. Improving diabetes outcomes requires involved self-management. Peer coaching programs can help patients engage in self-management while addressing individual and structural barriers. These peer coaching programs can be scaled with digital platforms to efficiently connect patients with peer supporters who can help with diabetes self-management. This study aimed to evaluate the implementation of a technology-enabled peer coaching intervention to support diabetes self-management among patients with uncontrolled diabetes. MetroPlusHealth, a predominant Medicaid health maintenance organization based in New York City, partnered with Pyx Health to enroll 300 Medicaid patients with uncontrolled diabetes into its 6-month peer coaching intervention. Pyx Health peer coaches conduct at least 2 evidence-based and goal-oriented coaching sessions per month with their assigned patients. These sessions are focused on addressing both behavioral and social determinants of health (SDoH) with the goal of helping patients increase their diabetes self-management literacy, implement self-management behaviors, and reduce barriers to ongoing self-care. Data analyzed in this study included patient demographic data, clinical data (patient's hemoglobin A1c [HbA1c]), and program implementation data including types of behavioral determinants of health and SDoH reported by patients and types of interventions used by peer coaches. A total of 330 patients enrolled in the peer mentoring program and 2118 patients were considered to be on a waitlist group and used as a comparator. Patients who enrolled in the peer coaching program were older; more likely to be English speakers, female, and African American; and less likely to be White or Asian American or Pacific Islander than those in the waitlist condition, and had similar HbA1c laboratory results at baseline (intervention group 10.59 vs waitlist condition 10.62) Patients in the enrolled group had on average a -1.37 point reduction in the HbA1c score (n=70; pre: 10.99, post 9.62; P<.001), whereas patients in the waitlist group had a -0.16 reduction in the HbA1c score (n=207; pre 9.75, post 9.49; P<.001). Among a subsample of participants enrolled in the program with at least 2 HbA1c scores, we found that endorsement of emotional health issues (β=1.344; P=.04) and medication issues (β=1.36; P=.04) were significantly related to increases in HbA1c. This analysis of a technology-enabled 1-on-1 peer coaching program showed improved HbA1c levels for program participants relative to nonprogram participants. Results suggested participants with emotional stressors and medication management issues had worse outcomes and many preferred to connect through phone calls versus an app. These findings support the effectiveness of digital programs with multimodal approaches that include human support for improving diabetes self-management in a typically marginalized population with significant SDoH barriers.

Effectiveness of written exposure therapy for Korean patients with post-traumatic stress disorder: non-randomized treatment-as-usual waitlist-controlled study

ABSTRACT Written exposure therapy (WET) is a five-session exposure-based protocol for treating post-traumatic stress disorder (PTSD). The brevity and tolerability of WET present the potential to overcome barriers in implementing evidence-based therapy for PTSD within the Korean mental healthcare system. This study investigated the effectiveness of WET in Korean patients with PTSD through a waitlist-controlled trial (KCT0008112). A total of 57 patients with PTSD were allocated non-randomly to either WET (n = 27) or treatment-as-usual waitlist groups (n = 30). Both groups were followed up until the twenty-fourth week after the initial session. Primary outcomes assessed included PTSD symptoms, depressive symptoms, and general function. In the WET group, significant improvements were observed in PTSD symptoms, depressive symptoms, and general function compared to the control group. After the waiting period, the waitlist group also participated in WET, and exhibited significant improvement in all scores. The between- and within-group effect sizes were large. The dropout rate in both groups was 10.9%, and the mean satisfaction ratings were 28.24 ± 3.33 (range 22–32; scale range 8–32). The present study provides evidence of WET successfully reducing PTSD and depressive symptoms and improving general function among Korean patients with PTSD. Moreover, WET was well tolerated and received by Korean patients with PTSD.

Breaking up with belongings: a pilot randomized controlled trial of an unguided web-based program to reduce overconsumption

AbstractNumerous consumers engage in wasteful and unsustainable consumption despite knowing it is associated with several personal, social, economic, and environmental harms. To aid consumers in reducing consumption, we created Breaking up with Belongings (BB), a fully automated web-based intervention with a downloadable workbook. Eligible participants were recruited using social media ads. They were Australian residents, aged 18 or older, fluent in English, had consistent computer and internet access, and reported having excess possessions and/or having difficulty making intentional decisions about possessions. We assessed the feasibility, acceptability, and preliminary efficacy of this intervention compared to a waitlist (WL) control in a 3-month, parallel, two-arm pilot randomized controlled trial. Over three weeks, 171 individuals screened for this study; 96 were eligible and randomized to condition (48 BB group, 48 WL group). Three-quarters of participants provided follow-up data and accessed the program. The BB group found the program acceptable and outperformed the WL group on two primary outcomes (cautious shopping and clutter removal) and on all secondary outcomes (impulsive buying, expenditure, hoarding tendencies, clutter-related impairment, object attachment, and emotion regulation). These findings will be used to enhance the program’s effectiveness and broader applicability, which will be tested through a larger randomized controlled trial.

The Efficacy of Eye Movement Desensitization and Reprocessing Treatment for Depression: A Meta-Analysis and Meta-Regression of Randomized Controlled Trials.

Background: Eye Movement Desensitization and Reprocessing (EMDR) therapy has gained attention for its potential effectiveness in treating depression beyond its initial use for PTSD. This systematic review and meta-analysis aims to evaluate the efficacy of EMDR in treating depression and to identify the variables influencing its effectiveness. Methods: A comprehensive search was conducted across databases, including MEDLINE, PubMed, and EMBASE, covering studies up to January 2023. A total of 521 studies were screened, and 25 studies with 1042 participants (522 EMDR, 520 control) met the inclusion criteria and were included in the meta-analysis. The inclusion criteria involved randomized controlled trials (RCTs) comparing EMDR to control conditions such as usual care or waitlist groups, with outcomes focused on changes in depression symptoms. Results: The results show that EMDR had a significant effect on reducing depression symptoms (Hedges' g = 0.75), with moderate heterogeneity being observed. The meta-regression indicated that the severity of depression was a significant predictor of EMDR's effectiveness, with greater effects in severe cases. Additionally, the systematic review analyzed and evaluated various theoretical models and related studies that explain how EMDR works for the treatment of depression, reporting on neurobiological models proposed in previous research. Conclusions: This study confirms that EMDR is effective in treating depression, particularly in severe cases, and highlights its potential as a non-pharmacological intervention. However, this study highlights the need for more standardized research and long-term evaluations to assess EMDR's lasting impact. Integrating EMDR into multimodal treatment plans and primary care, especially for treatment-resistant depression, could significantly improve patient outcomes.

Efficacy of internet-based cognitive behavioral and interpersonal treatment for depression in Arabic speaking countries: A randomized controlled trial

BackgroundPolitically and economically unstable contexts have been associated with increased prevalence rates of depression. Despite high demand, the availability of mental health experts and care systems is limited in Arabic-speaking countries. Internet-based interventions might provide an opportunity to treat patients independently of location. Therefore, we investigated the efficacy of internet-based cognitive behavioral treatment (iCBT) and interpersonal treatment (iIPT) for depression in Arabic-speaking countries. MethodsIn total, 743 Arabic-speaking adults with depression were randomly allocated to iCBT (n = 243), iIPT (n = 247), or waitlist (n = 253). Depressive, anxiety, and somatoform symptoms, perceived social support and quality of life (QoL) were assessed at pre-, and post-treatment and at three months follow-up. Multiple imputation was performed for missing data. Changes associated with treatment were analyzed using regression in the completer and intention-to-treat sample. ResultsParticipants in both treatment groups showed lower depressive and anxiety symptom severity, higher QoL, and perceived social support compared to the waitlist group (p < .001). Somatoform symptom severity was significantly lower in participants receiving iIPT compared to waitlist (p < .001). Differences between the two treatments in all outcomes were non-significant (p > .05). Three-month follow-up treatment effects regarding depressive symptoms were indicated. LimitationsThe sample mainly consists of educated, single, female adults. Three-month follow-up results rely on a small subsample and must be interpreted with caution. ConclusionsThis is the first randomized controlled trial to demonstrate the efficacy of iCBT and iIPT for depression in Arabic-speaking countries. It provides first indications that internet-based interventions might help specific individuals in this region.

A psychosocial bouldering intervention improves the well-being of young refugees and adolescents from the host community in Lebanon: results from a pragmatic controlled trial

BackgroundMental health and psychosocial support (MHPSS) is increasingly considered vital for addressing the needs of displaced communities. The mental health of young people in Lebanon, including members of the host community and refugees, has been severely affected by multiple crises. Physical activity (PA) is an effective means for enhancing mental health, but evidence of PA’s impact on mental health among forcibly displaced populations is still emerging and often varies widely across studies.MethodIn this waitlist-controlled study, we examined the effectiveness of an 8-week psychosocial bouldering group intervention offered by the nonprofit organization ClimbAID on psychological well-being, distress, self-efficacy, and social cohesion in a group of mostly Syrian refugee adolescents residing in the Bekaa Valley, Lebanon. The intervention consisted of 8 sessions and took place once a week for 2 h in a group of up to 12 adolescents with 2 trained facilitators and up to 2 volunteers, supervised by a climbing instructor and a social worker. Multilevel analyses were performed for all outcomes.Results233 people were included in the study. The dropout rate was approximately 33%. The IG improved significantly more than the waitlist group in terms of overall mental well-being and psychological distress. Group allocation was a significant predictor of improvements in mental well-being and psychological distress and showed a trend toward predicting self-efficacy. There was no positive impact of the intervention on social cohesion.ConclusionsEven in complex humanitarian settings of forced displacement, a psychosocial bouldering intervention reduces psychological distress and increases well-being in a mixed group of host and refugee youth in Bekaa, Lebanon.Trial registrationProspectively registered with ISRCTN 13005983, registered April 1st, 2022.

The effect of mindfulness-based art therapy (MBAT) on the body image of women with polycystic ovary syndrome (PCOS): a randomized controlled trial

BackgroundThe prevalence of polycystic ovary syndrome (PCOS) has increased in the last decade, resulting in enduring psychological effects, including negative body image. This study explored the effect of mindfulness-based art therapy (MBAT) on body image in women with PCOS.MethodsIn a randomized, single-blind, controlled trial conducted in Kerman, Iran, women of reproductive age (18–45) who were diagnosed with PCOS and met specific inclusion criteria were randomly allocated to either the MBAT intervention group or a control group placed on a therapy waiting list. The main focus of the study involved evaluating alterations in body image scores as the primary measure. Additionally, the study assessed secondary outcomes, which encompassed various domains of the Multidimensional Body-Self Relations Questionnaire (MBSRQ) before, immediately after, and one month after the intervention. The trial is registered with www.irct.ir (Registration code (25/01/2020): IRCT20170611034452N9).ResultsBetween August 2020 and January 2021, 66 participants were randomly assigned to the MBAT or waiting list group, and the study was completed by 60 women. At the end of the intervention, body image (adjusted mean difference from baseline (AMD) of 29.22 [95% CI 19.54, 38.90], P < 0.05) and at the one-month follow-up (AMD of 34.77 [95% CI 24.75, 44.80], P < 0.05) were greater in the MBAT group than in the waiting list group. At certain time points, some MBSRQ domains, including body area satisfaction (BASS) (p < 0.05), appearance evaluation (p < 0.05), fitness orientation (p > 0.05), health orientation (p < 0.05), and self-classified weight (p > 0.05), had higher scores than did the control group. However, only BASS had a conclusive effect size (large). Additionally, appearance orientation (p > 0.05), illness orientation (p > 0.05), health evaluation (p < 0.05), fitness evaluation (p > 0.05), and overweight preoccupation (p < 0.05) had lower scores with variable and inconclusive effect sizes.ConclusionsThe MBAT has potential as an effective approach for enhancing body image in women with PCOS. However, some MBSRQ domain results were inconclusive, likely due to the small sample size. Therefore, further research with a larger sample size is recommended.

Long-Term Effects of Individualized Acupuncture for Chronic Neck Pain : A Randomized Controlled Trial.

Long-term effects of individualized acupuncture in persons with chronic neck pain (CNP) remain unknown. To evaluate the efficacy and safety of pressure pain, sensory-based individualized acupuncture for relieving CNP. A 24-week multicenter randomized controlled clinical trial. (ChiCTR1800016371). Outpatient settings at 4 clinical centers in China from May 2018 to March 2020. 716 participants with CNP. Participants were randomly assigned to a waiting list (WL) group or to 1 of 3 interventions, which consisted of 10 sessions over 4 weeks: higher sensitive acupoints (HSA), lower sensitive acupoints (LSA), and sham acupoints (SA) acupuncture groups. The primary outcome was the change in the visual analogue scale (VAS) score for neck pain (range, 0 to 100) from baseline to 4 weeks, with a difference of 10 points considered the minimum clinically important threshold. The VAS was also assessed every 4 weeks through 24 weeks. The modified intention-to-treat population included 683 participants. The mean baseline VAS was 50.36, 50.10, 49.24, and 49.16 for HSA, LSA, SA, and WL, respectively. Compared with a mean baseline to week 4 change of -12.16 in the HSA group, the mean changes were -10.19 in the LSA group (net difference [ND], -1.97 [95% CI, -5.03 to 1.09]), -6.11 in the SA group (ND, -6.05 [CI, -9.10 to -3.00]), and -2.24 in the WL group (ND, -9.93 [CI, -12.95 to -6.90]). The intervention effects persisted at 24-week follow-up. Lack of complete blinding and limited generalizability. Individualized acupuncture interventions using high- or low-sensitivity acupuncture points were more effective in reducing CNP than SA and WL control groups sustained through 24 weeks, but the magnitude of relative improvement did not reach a minimal clinically important difference. National Natural Science Foundation of China.

Inflammatory biomarker findings from a randomized controlled trial of heated yoga for depression

BackgroundBoth heated and non-heated yoga have demonstrated antidepressant effects in randomized controlled trials (RCTs), with a greater number of studies evaluating non-heated yoga. Both heated and non-heated yoga may exert antidepressant effects in part by reducing inflammation. We report the first RCT evaluating the impact of heated yoga on inflammatory biomarkers in participants with moderate-to-severe depression. MethodsAdults (N = 80) were randomized to either a heated yoga or a waitlist group. The heated yoga group attended at least two community heated yoga classes per week for 8 weeks. The waitlist group completed an initial 8-week waitlist period, followed by the same heated yoga intervention. Blood samples were collected at baseline, at 8 weeks, and after the waitlist group completed the heated yoga intervention. Serum levels of inflammatory biomarkers (IFNγ, IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and TNF-α) were measured. Linear mixed models were used to explore three aims: 1) changes in inflammatory biomarker levels between treatment groups at the primary 8-week endpoint; 2) changes in inflammatory biomarkers from baseline to study endpoint for those in the waitlist phase of the waitlist group and those in the yoga phase of the waitlist group; and 3) the interaction between baseline inflammatory biomarkers and change in depression severity after 8-weeks of heated yoga vs. waitlist control. ResultsForty-five participants (n = 17 for the heated yoga group and n = 28 for the waitlist group) had inflammatory biomarker data available for analyses. Significant differences in inflammatory biomarker levels were not found between groups at the 8-week endpoint (Aim 1). Similarly, changes in inflammatory biomarkers from baseline to study endpoint did not differ for those in the waitlist phase of the waitlist group and those in the yoga phase of the waitlist group (Aim 2). Lastly, the interaction between baseline inflammatory biomarkers and change in depression severity after 8-weeks of heated yoga vs. waitlist control was not significant (Aim 3). ConclusionHeated yoga showed no significant reduction in inflammatory biomarker levels. Possible reasons include a small sample size, insufficient heated yoga dosage, timing of sampling, not targeting individuals with higher baseline inflammatory biomarker levels, or peripheral inflammatory biomarkers not influencing heated yoga’s antidepressant effects. Further research is needed to clarify the antidepressant mechanisms of heated yoga.

An epigenome-wide study of a needs-based family intervention for offspring of trauma-exposed mothers in Kosovo.

Maternal stress and trauma during pregnancy have been shown to influence cortisol levels and epigenetic patterns, including DNA methylation, in the offspring. This study aimed to determine whether a tailor-made family intervention could help reduce cortisol levels in children born to traumatized mothers, and to determine whether it effected offspring DNA methylation. The secondary aim was to determine whether the family intervention influenced DNA methylation aging, a marker of biological aging. A needs-based family intervention was designed to help address relational difficulties and family functioning, and included a focus on family strengths and problem-solving patterns. Women survivors of sexual violence during the Kosovar war in 1998-1999, and their families (children with or without partners) were randomly assigned to 10 sessions of a family therapy over a 3-5-month period, or to a waitlist control group. Both mothers and children completed assessments prior to and after the intervention phase. Children's blood samples collected at these two time points were used to measure cortisol and epigenome-wide DNA methylation patterns (Illumina EPIC array). Cortisol levels, and genome-wide DNA methylation changes pre-/postintervention were compared between children in the intervention and the waitlist groups. DNA methylation age and accelerated biological aging were calculated. Sixty-two women-child dyads completed the study, 30 were assigned first to the intervention group, and 32 to the waitlist control group. In adjusted linear regression, the family intervention was associated with a significant decline in cortisol levels compared to the waitlist control (β=-124.72, 95% confidence interval [CI]: -197.4 to -52.1, p=.001). Children in the intervention group, compared to the waitlist control group, showed >1% differential methylation degree at 5819 CpG (5'-C-phosphate-G-3') sites across the genome (p<.01), with the largest methylation difference being 21%. However, none of these differences reached genome-wide significant levels. There was no significant difference in DNA methylation aging between the two groups. We find evidence that a tailored family-based intervention reduced stress levels in the children (based on cortisol levels), and modified DNA methylation levels at a number of sites across the genome. This study provides some preliminary evidence to suggest the potential for tailored interventions to help break the intergenerational transmission of trauma, however, large studies powered to detect associations at genome-wide significant levels are needed.

Study protocol for a randomized controlled trial of neurofeedback mindfulness in chronic migraines

Chronic migraine is a debilitating headache disorder that is associated with excessive analgesic use. As the long-term use of analgesics could cause additional headaches due to medication overuse, there is a need to probe efficient nonprophylactic alternatives and migraineurs’ long-term adherence to such possible treatments. This protocol investigates the integration of neurofeedback and mindfulness which are the two common nonpharmacological therapies for migraines. We offer the use of portable EEG headbands for easy home-based data collection and consistent data access from researchers. In order to evaluate the efficacy of this recommended intervention, this is a protocol for a randomized control trial with a waitlisted group and an intervention group consisting of a daily attention task. The protocol presents important criteria which should be checked for consistency in longitudinal data collection from adults with chronic migraine.

Mindfulness-based stress reduction for chronic pain: Enhancing psychological well-being without altering attentional biases towards pain faces.

This study examines the effects of a Mindfulness-Based Stress Reduction (MBSR) program on psychological measures and attentional patterns to pain stimuli, using eye-tracking methods, in individuals with chronic pain. Thirty-two participants with chronic pain and no prior mindfulness experience were randomly assigned to an experimental group or a waiting list group. Both groups completed self-report measures of symptoms, well-being, and an attentional disengagement task using emotional faces as stimuli. Assessments were conducted at two points: before and after the intervention for the experimental group, with the waiting list group serving as a control. Before the MBSR program, chronic pain participants exhibited significant attentional biases towards pain-related stimuli during early attentional stages. Following the program, significant improvements were observed in depression, anxiety, stress, pain acceptance, overall well-being, and life satisfaction. However, it had a limited impact on attentional patterns, with only a significant increase in gaze duration across all stimuli. Despite the MBSR program's success in reducing symptoms associated with chronic pain, the lack of broader attentional improvements raises questions about the mechanisms responsible for psychological improvements. This study pioneers the use of eye-tracking to examine how MBSR influences attention in chronic back pain. While the program improved psychological well-being, it did not generally alter attentional patterns, except for an increased ability to maintain attention across stimuli. We discuss whether this attentional change could be associated with the increased acceptance observed in the MBSR program.

Effectiveness of Cognitive Orientation to daily Occupational Performance for autistic children with developmental coordination disorder.

To determine if the Cognitive Orientation to daily Occupational Performance (CO-OP) intervention is effective in improving motor skills of autistic children with developmental coordination disorder (DCD), and whether motor gains are maintained 3 months after therapy. In this quasi-experimental study, we recruited 27 autistic children (8-12 years) with DCD without intellectual disability. The treatment group received CO-OP intervention once weekly for 10 weeks, focusing on three child-chosen motor goals. The waitlist group received CO-OP 3 months later. Outcome measures included the Canadian Occupational Performance Measure (child ratings of motor performance and satisfaction), Performance Quality Rating Scale (therapist-observed movement quality), and the Bruninks-Oseretsky Test of Motor Proficiency, Second Edition(motor ability). Non-parametric analyses showed significant improvements (p < 0.013) in all outcomes. Follow-up analysis revealed significant improvements in performance (p < 0.001, W = 0.69), satisfaction (p < 0.001, W = 0.72), and movement quality (p < 0.001, W = 0.62). Despite slight declines at follow-up, overall improvements from pretest remained evident. The CO-OP intervention effectively improved motor skills of autistic children.

Survival benefit of ICD implantation for primary prevention in dilated cardiomyopathy

Objectives: Dilated cardiomyopathy (DCM) represents a significant cause of heart failure unrelated to ischemic heart disease, posing a high risk of sudden cardiac death (SCD) due to low left ventricular ejection fraction (LVEF). This study evaluates the survival benefits of implantable cardiac defibrillators (ICDs) for primary prevention in DCM patients. Methods: We enrolled 52 symptomatic non-ischemic cardiomyopathy patients (LVEF ≤ 35%, NYHA class II-III) eligible for ICD implantation in Afshar Hospital, Yazd, Iran, from 2014 to 2015. Exclusion criteria included those with ischemic indications or requiring cardiac resynchronization therapy. We divided patients into ICD recipients and those on a waiting list, collected the baseline data (age, functional class, LVEF), then followed up with patients to assess mortality rates. Results: Among 45 patients, 64.5% received ICDs while 35.5% were on the waiting list. The mean age was 57±13 years, predominantly male (67.3%). The ICD group had a significantly lower mortality rate (17.3%) than the waiting list group (42.7%, p = 0.54). Although age and functional class did not significantly predict outcomes, lower LVEF was a crucial factor for long-term survival. Despite some studies suggesting no survival benefit in non-ischemic heart failure, our findings highlight the efficacy of ICDs in reducing mortality among DCM patients. Conclusions: ICD implantation in DCM patients substantially reduces all-cause mortality compared to those awaiting the procedure, underscoring the importance of timely ICD deployment for primary prevention in this population.

Effects of an online mindfulness-based intervention on brain haemodynamics: a pilot randomized controlled trial using functional near-infrared spectroscopy.

Although many neuroimaging studies have evaluated changes in the prefrontal cortex during mindfulness-based interventions, most of these studies were cross-sectional studies of skilled participants or involved pre-post comparisons before and after a single session. While functional near-infrared spectroscopy is a useful tool to capture changes in the hemodynamic response of the prefrontal cortex during continuous mindfulness-based intervention, its ability to detect the accumulated effects of continuous mindfulness-based intervention is currently unclear. We investigated whether a 12-wk online mindfulness-based intervention changed the hemodynamic response of the prefrontal cortex during a verbal fluency task. Eighty-two healthy university students were randomly allocated to a 12-wk online mindfulness-based intervention group or a wait-list control group. The integral values of oxygenated hemoglobin measured using functional near-infrared spectroscopy before and after the intervention were compared to the values in the wait-list group. The intervention condition showed significantly greater functional near-infrared spectroscopy signal activation than the control condition; however, the effect sizes before and after the intervention were small. Thus, continuous mindfulness-based intervention could alter prefrontal cortex function, and functional near-infrared spectroscopy could be useful for measuring the accumulated effects of continuous mindfulness-based interventions. With a better understanding of the association between mindfulness and functional near-infrared spectroscopy signals, functional near-infrared spectroscopy can be used for biofeedback analyses.

The effect of Chinese herbal medicine on male factor infertility: study protocol for a randomized controlled trial.

The global prevalence of infertility is 9%, with male factors potentially accounting for 40% to 60% of cases. Conventional treatments can be ineffective, invasive, costly, and linked to adverse effects and high risks. Previous studies have shown that, Chinese herbal medicine (CHM) can regulate the hypothalamus-pituitary-testis axis, improve sperm abnormalities and quality, mitigate oxidative stress, and decrease DNA fragmentation index (DFI). Yet, the evidence backing the use of Chinese herbal medicine (CHM) for treating male factor infertility lacks conviction due to study design limitations, and there remains a scarcity of studies on the live birth rate following CHM treatment for male factor infertility. Here, we describe the rationale and design of a randomized waitlist-controlled trial to evaluate the effect of CHM on the live birth rate among males with infertility. This study is a single-center, randomized, waitlist-controlled study. A total of 250 couples diagnosed with male factor infertility will be enrolled in this study and then randomly allocated into two groups in a 1:1 ratio. Male participants in CHM group (treatment group) will receive CHM once a day for 3 months. Male participants in the waitlist group (control group) will not receive any treatment for 3 months. After 3 months, participants in both groups need to be followed up for another 12 months. The primary outcome will be the live birth rate; secondary outcomes include semen quality parameters, DFI and pregnancy related outcomes. Safety will also be assessed. The purpose of this trial is to explore the effects and safety of CHM on the live birth rate among couples dealing with male factor infertility. The outcome of this trial may provide a viable treatment option for male factor infertility. Chinese Clinical Trial Registry: ChiCTR2200064416. Registered on 7 October 2022, https://www.chictr.org.cn.

Is virtual reality-based cognitive training in parallel with functional near-infrared spectroscopy-derived neurofeedback beneficial to improve cognitive function in older adults with mild cognitive impairment?

Purpose Cognitive training in parallel with functional near-infrared spectroscopy (fNIRS)-derived neurofeedback has been identified to be beneficial in enhancing cognitive function in patients with mild cognitive impairment (MCI). However, effects of virtual reality (VR)-based cognitive training ensuring ecological validity in parallel with fNIRS-derived neurofeedback on neural efficiency has received little attention. This study investigated effects of VR-based cognitive training in parallel with fNIRS-derived neurofeedback on cognitive function and neural efficiency in patients with MCI. Method Ninety participants were randomly assigned into the active group (AG) receiving VR-based cognitive training in parallel with fNIRS-derived neurofeedback, the sham group (SG), or wait-list group (CG). The AG and SG group performed each intervention for fifteen minutes a session, for eight sessions. The Trail Making Test Part B and Backward Digit Span Test were used for outcomes. In addition, activity in the dorsolateral prefrontal cortex (DLPFC) during cognitive testing using fNIRS was measured. Results After the eight sessions, the AG achieved greater improvements in all outcomes than the other groups. In addition, the AG showed a lower DLPFC activity during cognitive testing than the other groups. Conclusions VR-based cognitive training in parallel with fNIRS-derived neurofeedback is superior to enhancing cognitive function and neural efficiency.

Efficacy of a Mind Space Application intervention on psychological outcomes in Thai university students with depression: A pilot randomized controlled trial

ObjectiveThis purpose of this study is to evaluate the effects of the Mind Space Application on psychological outcomes among Thai-university students with depression. MethodThai-university students with depression (N = 50) were recruited between November 2021 and January 2022. Participants were randomly assigned to either an 8-week mindfulness-based intervention via the Mind Space Application intervention or a waitlist control group. Stress, anxiety, depression, and mindfulness were assessed at baseline and post-intervention. ResultsPost-intervention, compared to waitlist control group, participants using the Mind Space Application reported large effects in the reduction of stress (d = 1.46, p < .001) and depression (d = 1.88, p < .001), small to moderate effects in reduction of anxiety (d = 0.35, p = .35), but no significant. Also, mindfulness scores were significantly higher (d = 1.90, p < .001) compared to the waitlist control group. ConclusionThai-university students with depression who used the Mind Space Application showed lower stress and depression and higher mindfulness compared to the waitlist group among. Similar applications may be useful as an alternative or combined with other treatments to improve psychological outcomes in other university student populations.

The randomized controlled trial (NAVKIDS2) of a patient navigator program created for children with chronic kidney disease

Patient navigators enable adult patients to circumnavigate complex health systems, improving access to health care and outcomes. Here, we aimed to evaluate the effects of a patient navigation program in children with chronic kidney disease (CKD). In this multi-center, randomized controlled trial, we randomly assigned children (aged 0-16 years) with CKD stages 1-5 (including children on dialysis or with kidney transplants), from low socioeconomic status backgrounds, and/or residing in remote areas, to receive patient navigation at randomization (immediate) or at six months (waitlist). The primary outcome was self-rated health (SRH) of participating children at six months, using intention to treat analysis. Secondary outcomes included caregivers’ SRH and satisfaction with health care, children’s quality of life, hospitalizations, and missed school days. Repeated measures of the primary outcome from baseline to six months were analyzed using cumulative logit mixed effects models. Semi-structured interviews were thematically evaluated. Of 398 screened children, 162 were randomized (80 immediate and 82 waitlist); mean age (standard deviation) of 8.8 (4.8) years with 64.8% male. SRH was not significantly different between the immediate and wait-listed groups at six months. There were also no differences across all secondary outcomes between the two groups. Caregivers’ perspectives were reflected in seven themes: easing mental strain, facilitating care coordination, strengthening capacity to provide care, reinforcing care collaborations, alleviating family tensions, inability to build rapport and unnecessary support. Thus, in children with CKD, self-rated health may not improve in response to a navigator program, but caregivers gained skills related to providing and accessing care.