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Efficacy and Safety of Electroacupuncture Through Nerve Stimulation in Patients With Anxiety Disorders: Protocol for a Randomized, Assessor-Blind, Three-Arm, Parallel-Group Clinical Trial.3 months agoAnxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation.
This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture).
This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability.
The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025.
In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders.
Clinical Research Information Service of the Republic of Korea KCT0008378; https://cris.nih.go.kr/cris/search/detailSearch.do/24503.
DERR1-10.2196/68166.Mental HealthAccessCare/ManagementAdvocacy -
Digital augmentation of aftercare for patients with anorexia nervosa: the TRIANGLE RCT and economic evaluation.3 months agoHigh-risk patients with complex anorexia nervosa are managed in inpatient/day patient care, but re-admission rates are high, and new treatments are needed.
To examine the effectiveness of a digital augmentation of aftercare (ECHOMANTRA).
Transition Care In Anorexia Nervosa through Guidance Online from Peer and Carer Expertise was a multicentre, parallel-group, superiority randomised controlled trial. ECHOMANTRA augmented treatment as usual was compared with treatment as usual. Patient-carer dyads were randomised using minimisation on a 1 : 1 ratio into ECHOMANTRA + treatment as usual (ECHOMANTRA) or treatment as usual alone.
Specialised United Kingdom inpatient/day patient sites (n = 31) participated.
Patient-carer dyads were randomised (n = 185 in ECHOMANTRA and n = 186 in treatment as usual).
The digital ECHOMANTRA intervention included self-management tools (recovery tips videos) for patients and task-sharing materials for carers (skill-sharing video), supplemented with guided group chat sessions. All participants randomised to ECHOMANTRA + treatment as usual had access to the psychoeducational materials and joint patient/carer chat sessions were also offered.
The primary outcome was patient distress at 12 months. Other outcomes included patient distress at 18 months, and eating disorder symptoms, social and work adjustment, and carer distress and skills at 12 and 18 months.
There was no evidence of an intervention effect on the Depression Anxiety Stress Scale-21 outcome for patients (n = 370) at 12 months, estimated effect 0.48, 95% confidence interval -0.20 to 0.23, standardised estimate (0.02, p = 0.87). In the economic analysis, the intervention was dominated by treatment as usual from both a health system and wider societal perspective, as ECHOMANTRA cost more and resulted in fewer quality-adjusted life-years gained. However, the uptake of the interactive component of the intervention (i.e. the facilitated and moderated online groups) was limited, with only 20% of the dyad members attending the pre-set minimal adherence level (i.e. both the patient and carer attending at least four online forum group sessions). The feedback about the intervention was predominantly positive. For example, the group facilitators were rated highly. However, some feedback was that the intervention offered too little, too late, and that a more personalised intervention would be more helpful.
Participants were diverse (e.g. 20% were being treated under the Mental Health Act), and a large proportion had a range of comorbidities (depression, anxiety, obsessive-compulsive disorder and autistic spectrum disorders), all factors impacting prognosis. Although efforts were made to enhance inclusion, diversity in terms of gender, sexuality and race was limited, and technological barriers and/or lack of a carer may have led to exclusion. The high level of non-adherence to the group support (80% dyads) may have contributed to the non-significant findings.
This guided self-management and task-sharing intervention was reviewed positively by some patients and supporters; however, there was no evidence that the intervention improved outcomes over usual aftercare.
Identifying mechanisms to increase engagement such as a more personalised approach to aftercare to address the diverse needs of this patient group are needed. Greater integration between intensive and step-down services with guidance from peer workers providing support may optimise care.
This trial is registered as ISRCTN14644379.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/68/09) and is published in full in Health Technology Assessment; Vol. 29, No. 31. See the NIHR Funding and Awards website for further award information.Mental HealthAccessCare/ManagementAdvocacy -
Real-world efficacy of equipment-free reduced-exertion high-intensity interval training in improving physical and mental health in inactive males: A randomized controlled trial.3 months agoAlthough reduced-exertion high-intensity interval training (REHIT) confers well-documented health benefits, most supporting evidence derives from laboratory studies that rely on specialized equipment. This study examined the real-world efficacy of equipment-free REHIT using burpees (BIT) in sedentary young adults.
A 12-week randomized controlled trial (n = 319 inactive men, age 20.5 ± 1.1 years, maximal oxygen uptake [VO2max] 37.7 ± 1.4 ml/min/kg) compared four cohorts: supervised BIT (n = 79), unsupervised BIT in real-world conditions (BIT-RW; n = 79), supervised cycling-based sprint interval training (SIT; n = 82), and a non-exercising control (CON; n = 79). Exercise groups performed 2 × 20s all-out effort sessions 3-5 times weekly. Training and affective responses were monitored throughout the intervention. Pre- and post-intervention outcomes included body composition, cardiorespiratory fitness, and mental health (stress, depression, anxiety, sleep quality, resilience, and health-related quality of life [QoL]).
The supervised BIT achieved 91 %-94 % of maximal heart rate (HRmax), compared to ∼90 % HRmax in BIT-RW. All exercise groups exhibited significant physiological improvements: 6 %-8 % body mass reduction, 8 %-13 % VO2max increase (η 2 p = 0.7-0.8, p < 0.001). Additionally, exercise training resulted in significant reductions in stress (49-61 %, p < 0.001), anxiety (37-86 %, p < 0.001), depression (14-48 %, p < 0.001), as well as improvements in resilience (22-27 %, p < 0.001) and QoL (14-27 %, p < 0.001). Supervised BIT matched SIT in VO2max gains (5.0 ± 0.6 ml/min/kg), while BIT-RW showed smaller physiological benefits (3.0 ± 0.6 ml/min/kg) but 10 % greater improvements in affective responses (p < 0.05).
This study demonstrates that a 40-s equipment-free REHIT protocol utilizing burpees improves both physical and mental health outcomes, even when implemented in unsupervised free-living settings. These findings suggest that BIT is an accessible and time-efficient training option for individuals constrained by limited access to equipment or professional oversight.Mental HealthAccess -
Complications and Outcome in Patients With Hydrocephalus Who Have Had a Ventriculoperitoneal Shunt Implanted.3 months agoHydrocephalus is the accumulation of cerebrospinal fluid in the ventricles of the brain. Ventriculoperitoneal shunt placement is one of the most commonly performed neurosurgical procedures and is necessary for the treatment of most forms of hydrocephalus.
The aim of the study was to determine demographic indicators, comorbidities, complications and outcome of patients with hydrocephalus after ventriculoperitoneal shunt implantation.
This is a retrospective study. Data on the subjects' age, gender, symptoms, degree of disability, complications, comorbidities and outcome after ventriculoperitoneal shunt implantation were recorded. All patients were clinically examined by neurologists and neurosurgeons and diagnosed through unified and standardized algorithms according to established guidelines for hydrocephalus. Cognitive functionality was assessed according to the Mini Mental State Test. Urinary incontinence was assessed based on patients' subjective feelings. Data on comorbidities and complications were collected from the patients' medical records. The degree of disability was assessed using the modified Rankin scale.
The average age of the subjects was 58.7 years, and the highest frequency of subjects was in the age group over 61 years (62.2%). There was no statistically significant difference in age in men (X=54.69, SD=18.77), or women (X=60.88, SD=19.96); t (35)=0.8, p=0.3. A statistically significant number of patients with hydrocephalus had a lower degree of disability after ventriculoperitoneal shunt implantation (p<0.05). Hypertension was the most common comorbidity with hydrocephalus (35.1%). Pneumonia was the most common general complication in patients with hydrocephalus (8.1%). Females had a statistically significantly worse survival (p=0.01). There was no statistically significant difference in the outcome of hydrocephalus patients in relation to age groups, comorbidities, general and complications after ventriculoperitoneal shunt implantation (p>0.05).
Patients with hydrocephalus after ventriculoperitoneal shunt implantation have a lower degree of disability, and female patients have statistically significantly worse survival. Hypertension is the most common comorbidity, and pneumonia the most common complication in patients with hydrocephalus. There is no statistically significant difference in the outcome of hydrocephalus patients in relation to age groups, comorbidities, general and complications after ventriculoperitoneal shunt implantation.Mental HealthAccessCare/ManagementAdvocacy -
The Frequency of Complications Associated with Breastfeeding in Breastfeeding Mothers.3 months agoComplications of breastfeeding occured mostly due to improper breastfeeding tecniques and poor education of mothers. These are reversible and can be prevented with proper education of mothers and medical personnel.
This research aimed to examine, through anonymous questionnaires, breastfeeding complications in the maternity unit, but also later during breastfeeding in the area covered by the district nurses of the Zagreb-West Health Center.
Out of 200 mothers participated and the research was conducted from January 2020 until May 2021.
Most of the pregnant women were beetwen 31-40 years old. 67.2% of them had vaginal birth. Most common complications during breastfeeding were engorged breasts (33.6%) while the rarest were mental disorders (3.1%) and nipple vasospasm (1.6%). Mothers used different kinds of solutions for these complications: silicone nipple shields, correction of position and proper breast grip, warm and cold compresses, breast pumping, massage and stimulation of breasts. As many as 46.9% of respondents had difficulties breastfeeding in the maternity unit, and the majority were primiparas (62.0%).
Complications of breastfeeding are more common with first-time mothers then with mothers who gave birth to multiple children. Primary solution for prevention, recognition of complications on time and managing complications is a continuous education of mothers and sensitization of overall public about advantages of breastfeeding.Mental HealthAccessAdvocacy -
Implementation of singing groups for postnatal depression: experiences of participants and professional stakeholders in the SHAPER-PND randomised controlled trial.3 months agoThere is a rapidly growing evidence base for the effectiveness of creative health interventions in improving mental health, but few studies have explored implementation and scaling of these interventions. The aim of this study was to evaluate the perceived acceptability, appropriateness, and feasibility of a ten-week singing group programme (Breathe Melodies for Mums (M4M)) for mothers experiencing symptoms of postnatal depression (PND) and their babies as well as the programme ingredients that affected these implementation outcomes.
A mixed methods design was adopted. Quantitative data was collected via the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) from 109 intervention participants at 6, 20, and 36 weeks and analysed descriptively. Qualitative semi-structured interviews were conducted with 22 programme participants and 15 professional stakeholders involved in implementing the programme. Qualitative data were analysed using framework analysis.
Quantitative results showed high levels of acceptability, appropriateness, and feasibility among M4M participants, with median scores of 5/5 achieved on the AIM, IAM and FIM at 20 and 36-week follow up. Qualitative results gave insights into the ingredients of M4M that made the programme acceptable, appropriate, and feasible to participants and professional stakeholders. These included "project" ingredients (dose, design, content), "people" ingredients (social composition, activity facilitation), and to a lesser extent, "context" ingredients (setting, project set-up). While participant and stakeholder experiences were largely positive, some challenges and suggestions for improvement were also identified, including broadening recruitment strategies to reach more women.
M4M was highly acceptable, appropriate, and feasible to participants and stakeholders. By identifying the "core" ingredients that facilitated implementation success and strategies to address implementation barriers, these findings have important implications for future implementation and scale-up of M4M and similar creative health programmes.
identifier (NCT04834622).Mental HealthAccessCare/Management -
Association of Irregular Menstruation and Sleep Duration With Depression Symptoms in Women of Childbearing Age.3 months agoIntroduction With the decline of the fertility rate, women of childbearing age are playing an increasingly important role in social development, and paying attention to their physical and mental health is of great significance. We aimed to explore the association of irregular menstruation and sleep duration with depression symptoms in women of childbearing age. Methods We collected data from the National Health and Nutrition Examination Survey (NHANES) from 2013 to 2018. Irregular menstruation and sleep duration were derived from questions, and depression symptoms were assessed by questionnaire data. Generalized additive model (GAM), threshold effect analysis, and binary logistic regression were used in this study. Results A total of 3141 participants aged 18-45 years were enrolled in the study, and 9.55% had depression symptoms. Both irregular menstruation (OR=1.595, (95% CI: 1.065-2.389)) and sleep duration (OR=0.872, (95% CI: 0.774-0.983)) were associated with depression symptoms after adjusting for all covariates. GAM and threshold effect analysis showed a U-shaped relationship between sleep duration and depression symptoms, and the inflection point of sleep duration was nine hours. An interaction of irregular menstruation and sleep duration on depression symptoms was found (OR=0.736, (95% CI: 0.554-0.977), P=0.035). Conclusions Irregular menstruation and sleep duration were associated with depression symptoms, and there was an interaction of irregular menstruation and sleep duration on depression symptoms in women of childbearing age. These findings may help women of childbearing age to be aware of the negative impact of irregular menstruation and improper sleep duration on depression symptoms and might provide potential targets for intervention.Mental HealthAccess
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Patient Perception of University Hospitals' PCs for People Initiative.3 months agoThe COVID-19 pandemic and post-pandemic world have highlighted the integral part that social connections play in one's mental and emotional well-being. The modern world had to suddenly adapt and accommodate an abundantly virtual one. Those who were unable to make these technological adaptations, many being low socioeconomic households, were facing many new obstacles, such as losing in-person jobs and being disconnected from their community and services by not having the technology to stay in contact, all while living through a global pandemic. University Hospitals understands and recognizes the value of connectivity for lower-income households, and through their Rainbow Connect program, they have partnered with a non-profit technology distribution service to provide a laptop computer and six-month prepaid access to a broadband internet receiver to Medicaid patients. The aim of this study is to evaluate the impact of this initiative on the lives of its recipients. Through an attitudinal survey administered on the day they received their computer and internet hotspot and again after six months, researchers investigated the change in perspective the 100 participants had about owning a PC and what it could do for their lives. This study found significant improvement in participants' perceived mental, emotional, and physical well-being. Participants reported feeling a greater sense of connection to friends, family, and their community. They felt their health was at less risk by being able to stay home for health appointments and by ordering goods and services to their home. They also revealed new avenues for work, as those who have difficulty leaving the house now have the ability to work remotely and attain an income. These results are important in highlighting the changes in recipient perception and encouraging the expansion of similar programs that aim to bridge the digital access gap.Mental HealthAccessCare/ManagementPolicy
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Microbial Spectrum of Acute Encephalitis Syndrome With Special Reference to Non-Japanese Encephalitis Cases.3 months agoNortheast India is endemic for Japanese encephalitis (JE), which causes acute encephalitis syndrome (AES). Though there is no specific therapy for JE, many etiological agents of AES are treatable. Hence, this study aims to evaluate the AES cases for their etiologies, laboratory parameters, and associated clinical manifestations.
A hospital-based prospective observational study was carried out, enrolling all consecutive cases of AES satisfying the World Health Organization (WHO) definition. Blood was tested for the malaria parasite. Cerebrospinal fluid (CSF) samples were processed by Gram staining, India ink staining for Cryptococcus, Ziehl-Neelsen staining for acid-fast bacilli (AFB), and culture for other bacteria and fungi. Serum and CSF samples lacking the Japanese encephalitis virus (JEV) IgM were processed for the detection of other etiologies. The CSF polymerase chain reaction (PCR) method was used to detect Enterovirus, Haemophilus influenzae, Neisseria meningitidis, and herpes simplex virus, and serum IgM enzyme-linked immunoassay (ELISA) detected scrub typhus, Leptospira, dengue, chikungunya, and West Nile antibodies.
Out of 395 AES cases tested, 77 were found to be positive for non-JE etiologies. Of these, dengue virus (n=32/371; 8.6%) was the most common, followed by scrub typhus (n=16/348; 4.6%) and Leptospira (n=10/362; 2.8%). Positive cases showed CSF pleocytosis (>5 WBC/cumm) and significantly higher protein level (n=6/11; 55%) and sugar level (n=8/11; 73%) in Streptococcus pneumoniae. All cases presented with fever (n=11/11; 100%), followed by altered mental status (n=18/19; 94.7%) and seizure (n=22/32; 68.7%).
The number of non-JE causes of AES in Assam is higher. Scrub typhus, dengue virus, and Leptospira are other major infectious etiologies of AES that are treatable. Timely diagnosis of such cases will help reduce AES-related complications and mortality.Mental HealthAccessCare/Management -
Cultural adaptation of a digital therapeutic for insomnia for Spanish-speaking Hispanic adults in the United States: a qualitative study.3 months agoDigital therapeutics represent an innovative and scalable means for addressing inequities in access to behavioural healthcare. However, the adaptation of digital health technologies for minoritised communities to promote equitable uptake remains elusive, and the procedures and outcomes are often not systematically detailed. Our aim was to describe the equity-centred, theory-informed process we undertook to culturally adapt, for Spanish-speaking Hispanic adults, the first Food and Drug Administration authorized, self-guided, prescription digital therapeutic for insomnia.
We used an integrated four-stage model of cultural adaptation to guide the process and a cultural adaptation taxonomy of common elements to report findings. A bilingual (Spanish/English) community advisory board provided critical input. In Stages 1-3, ten focus groups and 13 individual interviews were conducted to obtain feedback on cultural adaptations and digital components. In Stage 4, a pilot study was undertaken to assess usability of the adaptations. Qualitative data were analysed using thematic content analysis and coded by type of adaptation.
53 Hispanic adults with chronic insomnia were invited to participate in all stages; Mean age = 53.6 years (SD = 11.4), 64.2% women, 49% less than college, and 62.3% reported low technological confidence. Cultural adaptations were made in each taxonomy component (83 total); the adapted program had high usability (System Usability Scale = 95/100). Surface-level adaptations (34.9% of changes made based on observable characteristics), which included changes to the characters (storylines, images), activities, and content to reflect the within-Hispanic group heterogeneity. Deep-level adaptations (65.1% of changes made based on sociocultural factors) included the integration of sociocultural values (familismo) and environment/burdens (stressors, social determinants, immigrant status) into the intervention content, and more in-App guidance/instruction to facilitate navigation for low health and digital literacy.
We produced a digital therapeutic for insomnia for Hispanic adults across the digital literacy spectrum with high acceptability, usability, and potential to confer clinical benefits.
This project was supported by AHRQ HS024274 and a Provost Grant from Columbia University.Mental HealthAccessCare/Management