The Effects of Mindfulness for Youth (MYmind) versus Group Cognitive Behavioral Therapy in Improving Attention and Reducing Behavioral Problems among Children with Attention-Deficit Hyperactivity Disorder and Their Parents: A Randomized Controlled Trial.

INTRODUCTION: There is a lack of studies evaluating mindfulness-based interventions for children with attention-deficit hyperactivity disorder (ADHD) compared with an evidence-based control. This randomized controlled trial (RCT) evaluated the effects of mindfulness for youth (MYmind) in improving children's attention, behavior, and parent-related outcomes versus cognitive behavioral therapy (CBT). METHODS: A total of 138 families of children with ADHD aged 8-12 years were recruited from the community with 69 randomized to MYmind and 69 to CBT. Participants were assessed at baseline, immediately after intervention, at 3 months and 6 months. The primary outcome was the attention score of the Sky Search subtest of the Test of Everyday Attention for Children (TEA-Ch). Secondary outcomes were child behavior and parent-related assessments. Linear mixed models were used to assess the efficacy of MYmind compared with CBT. RESULTS: Both MYmind and CBT significantly improved children's attention score at 6 months (MYmind: ß = 1.48, p = 0.013, Cohen's d = 0.32; CBT: ß = 1.46, p = 0.008, d = 0.27). There were significant within-group improvements in most secondary outcomes. No significant difference was shown for both primary or secondary outcomes between the two arms at any time point. CONCLUSIONS: Both MYmind and CBT appeared to improve children's attention and behavior outcomes, although no difference was found between these two interventions. This is the largest RCT so far comparing MYmind and CBT although there was loss of follow-up assessments during the pandemic. Further RCTs adopting a non-inferiority design are needed to validate the results.

A randomized controlled trial on the effects and acceptability of individual mindfulness techniques - meditation and yoga - on anxiety and depression in people with Parkinson's disease: a study protocol.

BACKGROUND: Between 40 and 50% of patients with Parkinson's disease (PD) experience anxiety and depression, associated with impaired physical function, high care dependency and mortality. Recently, the United States National Institutes of Health has urged the implementation of mindfulness practices in chronic illness care. Most research to date has examined the effects on chronically ill patients of complex interventions using a combination of mindfulness techniques. In PD patients, however, such complex modalities appear to hinder the technique mastery. Hence, the aim of this trial is to investigate the effects and underlying mechanism of individual mindfulness techniques among PD patients, as well as exploring participants' experience in using individual mindfulness techniques as a lifestyle intervention for stress and symptom management. METHODS: We will conduct an assessor-blind three-arm randomized waitlist-controlled trial with a descriptive qualitative evaluation. Up to 168 PD patients will be recruited from community settings and out-patient clinics, and randomized to meditation, yoga, or usual care group. Meditation and yoga sessions of 90-minute are held weekly for 8 weeks. Primary outcomes include anxiety and depression. Secondary outcomes include PD-related motor and non-motor symptoms and quality-of-life; and level of mindfulness and biomarkers of stress and inflammatory responses will be measured as mediating variables. All outcome evaluations will be assessed at baseline, 8 weeks, and 24 weeks. Following the intention-to-treat principle, generalized estimating equation models and path analysis will be used to identify the treatment effects and the mediating mechanisms. A subsample of 30 participants from each intervention group will be invited for qualitative interviews. DISCUSSION: The study would also generate important insights to enhance the patients' adaptation to debilitating disease. More specifically, symptom management and stress adaptation are highly prioritized healthcare agenda in managing PD. The research evidence will further inform the development of community-based, nurse-led compassionate care models for neurodegenerative conditions, which is complementary to existing health services. TRIAL REGISTRATION: WHO Primary Registry - Chinese Clinical Trials Registry number: ChiCTR2100045939; registered on 2021/04/29 ( https://www.chictr.org.cn/showproj.html?proj=125878 ).

Prevalence, Patterns, and Clinical Severity of Long COVID among Chinese Medicine Telemedicine Service Users: Preliminary Results from a Cross-Sectional Study.

INTRODUCTION: The emergence and persistence of symptoms after acute COVID-19 is expected to become a major burden on healthcare systems. We assessed the features of the post-COVID-19 Syndrome (Long COVID) burden in a cohort of COVID-19 patients during the fifth major wave in Hong Kong. METHODS: A cross-sectional study of 135 patients with confirmed COVID-19 from Feb to Apr 2022 who utilized traditional Chinese medicine telemedicine services was conducted. The COVID-19 Yorkshire Rehabilitation Scale was administered using an online survey 12 weeks after the COVID-19 infection. Prevalence of symptom severity and functional impairments were assessed to identify burdens and patterns. The correlation between symptom severity, functional impairments, patient characteristics, and overall health was evaluated. RESULTS: The mean age was 46.8 years, with 46 (34.1%) males. Symptoms, functional impairments, and overall health worsened significantly when compared to the status prior to the infection. More than 50% reported the following sequelae 12 weeks after the acute infection: breathlessness, laryngeal or airway complications, fatigue, weakness, sleep, cognition, and anxiety. The presence of a single symptom or functional impairment significantly correlated with at least seven other problems positively, except for pain. Severity tended to be higher among vulnerable groups, including those who were chronic disease patients, older, less well educated, female, or had incomplete COVID-19 vaccinations. CONCLUSIONS: Long COVID is a significant healthcare burden among telemedicine users in Hong Kong, with complex needs for symptom and functional impairment management. Designing relevant health and rehabilitation services tailored to the needs of these patients is warranted.

Street-view and traditional greenness metrics with adults' sitting time in high-density living in Hong Kong: Comparing associations, air pollution and noise roles, and population heterogeneity.

BACKGROUND: Emerging evidence suggests neighborhood greenness is associated with physical activity; however, the sitting-specific associations with multi-source greenness metrics remain unclear, especially in high-density cities. OBJECTIVES: This cross-sectional study examined: 1) the associations of street-view greenness (SVG) and traditional greenness metrics (i.e., Normalized Difference Vegetable Index (NDVI) and park density) with sitting time; 2) the potential moderating/mediating roles of objective/perceived air pollution and perceived roadside noise; and 3) how the associations vary by demographics and socioeconomic status. METHODS: Interview survey data of 1977 adults in Hong Kong from 2014 and 2015 was linked to environmental data. Using an object-based image classification algorithm, SVG was derived from Google Street View images, capturing human-viewed street-level greenery. NDVI was derived from Landsat 8 satellite images using the normalized difference between the near-infrared and red bands. Park density was calculated by point density. In the main analyses including regressions, parallel mediation, interaction, and stratified models, the environmental metrics were measured within a 1000-m Euclidean buffer of residence. RESULTS: SVG and park density were negatively associated with sitting time after adjusting for covariates including physical activity while NDVI was not significantly associated with sitting time, and results were robust with 800-1800 m Euclidean and 1400-1800 m network distance. Greenness-sitting associations were not moderated/mediated by perceived air pollution/roadside noise while SVG-sitting associations were moderated by objective NO2, O3, and PM2.5 and mediated by O3. SVG-sitting associations differed by age, having under-school-aged children, birthplace, education, and occupation type while associations between traditional greenness metrics and prolonged sitting showed no significant population heterogeneity. CONCLUSIONS: SVG appears to be more accurate in estimating exposure than traditional metrics to reflect greenness-sitting associations, objective air pollution moderating and mediating roles, and population heterogeneity, which emphasizes the importance of street-level greenness planning for health promotion in terms of reducing sitting time.

The Effects of a Mindfulness-Based Family Psychoeducation Intervention for the Caregivers of Young Adults with First-Episode Psychosis: A Randomized Controlled Trial.

OBJECTIVE: In this study, we investigated the effects of a mindfulness-based family psychoeducation (MBFPE) program on the mental-health outcomes of both caregivers and young adults with first-episode psychosis with an onset in the past three years through a multi-site randomized controlled trial. We also studied the outcomes of three potential mediating effects of interpersonal mindfulness, expressed emotions, and non-attachment on the program. METHOD: We randomly assigned 65 caregivers of young adults with psychosis to MBFPE (n = 33) or an ordinary family psychoeducation (FPE) program (n = 32); among them, 18 young adults in recovery also participated in the evaluation of outcomes. RESULTS: Intent-to-treat analyses were conducted. No significant time × group interaction effects of MBFPE and FPE programs were found in any of the caregivers' outcomes. However, the young adults with psychosis reported higher levels of recovery after the MBFPE program than after the ordinary FPE program (F = 8.268, p = 0.012, d = 1.484). They also reported a larger reduction in over-involvement of their caregivers (F = 4.846, p = 0.044, d = 1.136), showing that MBFPE had a superior effect to FPE in promoting recovery and reducing over-involvement. CONCLUSIONS: A brief psychoeducation program may not reduce the burden on or improve the mental-health outcome of caregivers of individuals with recent-onset psychosis. However, integrating mindfulness into a conventional family psychoeducation program may reduce the expressed emotions of caregivers, especially over-involvement. Further studies should explore how psychoeducation programs can reduce the impact of psychosis on family through sustainable effects in terms of reducing their burden and expressed emotions, using a rigorous study and adequate sample size.

A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability.

BACKGROUND: Lateral ankle sprain (LAS) is a common injury. Conservative care is not uniformly effective. Chronic ankle instability (CAI) results in up to 70% of patients with LAS in the physically active population. LAS, together with subsequent osteochondral lesions and pain in many patients, leads to the development of post-traumatic osteoarthritis, resulting in a substantial direct and indirect personal and societal health burden. Dextrose prolotherapy (DPT) is an injection-based therapy for many chronic musculoskeletal conditions but has not been tested for CAI. This protocol describes a randomized controlled trial to test the efficacy of DPT versus normal saline (NS) injections for chronic ankle instability (CAI). METHODS AND ANALYSIS: A single-center, parallel-group, randomized controlled trial will be conducted at a university-based primary care clinic in Hong Kong. A total of 114 patients with CAI will be randomly allocated (1:1) to DPT and NS groups. The primary outcome will be the Cumberland Ankle Instability Tool scores at 1 year. The secondary outcomes will be the number of re-sprains in 1 year, the Star Excursion Balance Test, the 5-level of EuroQol 5-dimension questionnaire, and the Foot and Ankle Ability Measure. All outcomes will be evaluated at baseline and at 16, 26, and 52 weeks using a linear mixed model. DISCUSSION: We hypothesized the DPT is a safe, easily accessible, and effective treatment for patients with CAI. This RCT study will inform whether DPT could be a primary non-surgical treatment for CAI. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040213 . Registered on 25 November 2020.

A randomized clinical trial of genetic testing and personalized risk counselling in patients with type 2 diabetes receiving integrated care -The genetic testing and patient empowerment (GEM) trial.

AIMS: We evaluated the effect of personalized risk counseling incorporating clinical and genetic risk factors on patient empowerment and risk factor control in diabetes. METHODS: Patients with type 2 diabetes (T2D) with suboptimal glycaemic control (HbA1c ≥ 7.5%) were randomized to a genetic counselling (GC) or control group. All patients underwent genetic testing for alleles at three loci associated with diabetic complications. The GC group received additional explanation of the joint associations of genetic and modifiable risk factors on risk of complications. All patients were reassessed at 12 months including validated questionnaires for patient reported outcomes. The primary outcome was proportion of patients reaching ≥ 3 of 5 predefined treatment targets (HbA1c < 7%, BP < 130/80 mmHg, LDL-C < 2.6 mmol/L, Triglyceride < 2.0 mmol/L, use of renin-angiotensin system inhibitors). Secondary outcomes included new-onset chronic kidney disease or microalbuminuria and patient reported outcome measures. RESULTS: A total of 435 patients were randomized and 420 patients were included in the modified intention-to-treat analysis. At 12 months, the proportion of patients who attained ≥ 3 targets increased from 41.6% to 52.3% in the GC group (p = 0.007) versus 49.5% to 62.6% in the control group (p = 0.003), without between-group difference. Both groups had similar reduction in HbA1c, LDL-C and increased use of medications. In per protocol analysis, the GC group had higher diabetes empowerment, with reduced diabetes distress. In the GC group, the greatest improvement in positive attitude and self-care activities was observed in the intermediate to high genetic risk score (GRS) groups. CONCLUSIONS: In patients with T2D receiving integrated care, additional counselling on genetic risk of complications did not further improve risk factor control, although the improvement in self-efficacy warrants long-term evaluation.

Controlled-release oral melatonin supplementation for hypertension and nocturnal hypertension: A systematic review and meta-analysis.

Oral melatonin is a potential alternative treatment for hypertension and nocturnal hypertension. However, high-quality and relevant meta-analyses are lacking. This meta-analysis aimed to investigate whether oral melatonin supplementation reduces daytime/asleep blood pressure and cardiovascular risk, improves sleep quality, and is well-tolerated compared with placebo. Relevant articles were searched in multiple databases, including MEDLINE, EMBASE, CINAHL Complete, and the Cochrane Library, from their inception to June 2021. The included studies were randomized controlled trials recruiting patients with hypertension, using oral melatonin as the sole intervention, and investigating its effect on blood pressure. The mean out-of-office (including 24-h, daytime, and asleep) systolic and diastolic blood pressures, sleep quality, and side effects were compared between the melatonin and placebo arms using pairwise random-effect meta-analyses. A risk of bias assessment was performed using the Cochrane risk-of-bias tool. Four studies were included in the analysis and only one study was considered to have a low risk of bias. No study reported on cardiovascular risk or outcomes. Only controlled-release melatonin (not an immediate-release preparation) reduced asleep systolic blood pressure by 3.57 mm Hg (95% confidence interval: -7.88 to .73; I2  = 0%). It also reduced asleep and awake diastolic blood pressure, but these differences were not statistically significant. Melatonin improves sleep efficacy and total sleep time and is safe and well-tolerated. Due to the limited number of high-quality trials, the quality of evidence was low to very low. Therefore, adequately powered randomized controlled trials on melatonin are warranted.

Effects of Hypertonic Dextrose Injection (Prolotherapy) in Lateral Elbow Tendinosis: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically review the effectiveness of hypertonic dextrose prolotherapy (DPT) on pain intensity and physical functioning in patients with lateral elbow tendinosis (LET) compared with other active non-surgical treatments. DATA SOURCES: Systematic search of Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Web of Science, PubMed, Dimensions, Global Health, NHS Health Technology Assessment, Allied and Complementary Medicine, and OVID nursing database from inception to June 15, 2021, without language restrictions. STUDY SELECTION: Two reviewers independently identified parallel or crossover randomized controlled trials that evaluated the effectiveness of DPT in LET. The search identified 245 records; data from 8 studies (354 patients) were included. DATA EXTRACTION: Two reviewers independently extracted data and assessed included studies. The Cochrane Risk of Bias 2 tool was used to evaluate risk of bias. The Grading of Recommendation Assessment, Development, and Evaluation approach was used to assess quality of the evidence. DATA SYNTHESIS: Pooled results favored the use of DPT in reducing tennis elbow pain intensity compared with active controls at 12 weeks postenrollment, with a standardized mean difference of -0.44 (95% confidence interval, -0.88 to -0.01, P=.04) and of moderate heterogeneity (I2=49%). Pooled results also favored the use of DPT on physical functioning compared with active controls at 12 weeks, with Disabilities of the Arm, Shoulder and Hand scores achieving a mean difference of -15.04 (95% confidence interval, -20.25 to -9.82, P<.001) and of low heterogeneity (I2=0.0%). No major related adverse events have been reported. CONCLUSIONS: DPT is superior to active controls at 12 weeks for decreasing pain intensity and functioning by margins that meet criteria for clinical relevance in the treatment of LET. Although existing studies are too small to assess rare adverse events, for patients with LET, especially those refractory to first-line treatments, DPT can be considered a nonsurgical treatment option in carefully selected patients. Further high-quality trials with comparison with other injection therapies are needed.

Effectiveness of a mindfulness intervention for older adults to improve emotional well-being and cognitive function in a Chinese population: A randomized waitlist-controlled trial.

BACKGROUND: To investigate the effect of a modified mindfulness-based stress reduction (mMBSR) program on mental well-being and cognitive function of older adults. METHOD: Two hundred and fourty-six participants were randomly assigned to mMBSR (n = 120) group or waitlist control group which received mMBSR at 2-month (n = 123). Data collected at baseline, 2 and 4 months after recruitment. PRIMARY OUTCOME: mental well-being: Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). SECONDARY OUTCOMES: Five Facet Mindfulness Questionnaire Short Form, Montreal Cognitive Assessment (MOCA), Verbal Fluency Test (VFT), international shopping list test, self-compassion scale, peace of mind scale, geriatric depression scale (GDS), and Pittsburgh sleep quality index (PSQI). In modified-intention-to-treat analysis, paired t-test for within group comparison, and ANCOVA to compare group differences at 2-months with adjustment of baseline values. RESULTS: Most participants were female (83.7%), living with others (67.0%), and married (50.7%). No significant difference of baseline characteristics except sleep quality. At 2 months, intervention group reported better mental well-being (0.9, 95%CI: 0.1-1.8, p = 0.025) and less depressive symptoms (-1.0; 95%CI: -1.7 to -0.3, p = 0.004). Within group at 2 months, intervention group had improvement in: mental well-being (SWEMWBS: 22.5-23.4, p = 0.011), cognitive function (MOCA: 24.6-25.8, p < 0.001; VFT: 38.7-42.1, p < 0.001), depressive symptoms (GDS: 4.1-3.1, p < 0.001), and sleep quality (PSQI: 8.3-6.7, p < 0.001). All these changes, except mental well-being, were sustained at 4 months. DISCUSSION: Attrition rate was 14% and mindfulness intervention was found to be feasible and acceptable in older adults. Major limitation of the study was the absence of an active control group to control for non-specific effect.

Mindfulness Awareness Is Associated With a Lower Risk of Anxiety and Depressive Symptoms in Older Adults With Neurocognitive Disorders.

Background: Apart from depressive disorders, there are great interests in adopting mindfulness based interventions (MBIs) for other mental health conditions. Depression and anxiety are common in people with neurocognitive disorders (NCD). The potential of MBIs as an adjuvant treatment in this cognitively at-risk group should be further explored. Objectives: The current study explored the association between depression and anxiety symptoms with dispositional mindfulness in older adults, and if same association stays in the context of cognitive impairment. Methods: The Hong Kong Mental Morbidity Survey for Older People (MMSOP) is an ongoing epidemiology study of the prevalence of neurocognitive and mental disorders in adults aged 60 years or over in Hong Kong. MMSOP evaluated cognitive function, psychiatric symptoms (Clinical Interview Schedule-revised, CIS-R), chronic physical disease burden, psychosocial support, and resilience factors, including dispositional mindfulness as measured by the Mindful Attention Awareness Scale (MAAS). We analyzed the impact of MAAS on CIS-R and potential moderation effects of mindfulness. Results: In March 2021, 1,218 community dwelling participants completed assessments. The mean age of the sample is 69.0 (SD 6.9) years. Eight hundred and two participants (65.7%) were not demented (CDR 0) and 391 (32%) and 25 (2%) were categorized as having mild NCD (CDR 0.5) and major NCD (CDR 1 or more), respectively. One hundred forty-three (11.7%) satisfied ICD-10 criteria for anxiety or depressive disorder as measured by CIS-R. Linear regression analysis showed that female gender, CIRS, and MAAS scores were significant factors associated with CIS-R scores. MAAS scores moderated and attenuated the impact CIRS on CIS-R (adjusted R 2 = 0.447, p < 0.001). MAAS scores remained as significant moderator for CIRS in patients with NCD (CDR ≥ 0.5) (adjusted R 2 = 0.33, p < 0.001). Conclusion: Interim findings of the MMSOP suggested that dispositional mindfulness is associated with lower level of mood symptoms in community dwelling older adults in Hong Kong. The interaction effects further suggested that high mindful awareness may reduce the adverse effects of chronic physical morbidity on mental health. The observation stayed in the participants with cognitive impairment. We should further explore MBIs as a non-pharmacological treatment for in older adults at-risk of physical morbidity and cognitive decline.

Efficacy of hypertonic dextrose injection (prolotherapy) in temporomandibular joint dysfunction: a systematic review and meta-analysis.

Hypertonic dextrose prolotherapy (DPT) has been reported to be effective for temporomandibular disorders (TMDs) in clinical trials but its overall efficacy is uncertain. To conduct a systematic review with meta-analysis of randomized controlled trials (RCTs) to synthesize evidence on the effectiveness of DPT for TMDs. Eleven electronic databases were searched from their inception to October, 2020. The primary outcome of interest was pain intensity. Secondary outcomes included maximum inter-incisal mouth opening (MIO) and disability score. Studies were graded by "Cochrane risk of bias 2" tool; if data could be pooled, a meta-analysis was performed. Ten RCTs (n = 336) with some to high risk of bias were included. In a meta-analysis of 5 RCTs, DPT was significantly superior to placebo injections in reducing TMJ pain at 12 weeks, with moderate effect size and low heterogeneity (Standardized Mean Difference: - 0.76; 95% CI - 1.19 to - 0.32, I2 = 0%). No statistically significant differences were detected for changes in MIO and functional scores. In this systematic review and meta-analysis, evidence from low to moderate quality studies show that DPT conferred a large positive effect which met criteria for clinical relevance in the treatment of TMJ pain, compared with placebo injections.Protocol registration at PROSPERO: CRD42020214305.

Brief Report: Mindfulness Training for Chinese Adolescents with Autism Spectrum Disorder and Their Parents in Hong Kong.

This study investigated the feasibility and preliminary effectiveness of a concurrent mindfulness program (MYmind) on Chinese adolescents with autism spectrum disorder and their parents in Hong Kong, China using a randomized controlled trial with a waitlist control group. Results showed the study had 80% compliance rate, 0% dropout rate, and 89% response rate. Between-group comparisons showed mindfulness had trend effects on parent's rumination (g = 1.16), mindful parenting (d = 0.6), parenting style (d = 0.59), and parenting stress (d = 0.5). The study demonstrated the feasibility of the MYmind program in the Chinese context. A larger trial with longer follow-up period is suggested to better examine the effect of mindfulness on adolescents with ASD and their parents.

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.

PURPOSE: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA). METHODS: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model. RESULTS: Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported. CONCLUSION: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

A Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Young Adults With First Episode Psychosis: A Study Protocol.

Family psychoeducation (FPE) has been recommended as a major component in the treatment of psychosis. Many previous studies have implemented an intensive program design that often only emphasized improvements in patients' illness outcomes but the benefits for caregivers were limited. There have been calls for a time-limited but cost-effective FPE program to mitigate the looming reality of the suffering of people with psychosis and their families. A Brief Mindfulness-Based Family Psychoeducation for psychosis program is developed to reduce caregivers' burden and promote young adult's recovery. A randomized controlled trial will be conducted to compare this intervention with an ordinary FPE intervention. Both arms will involve six sessions, with a total contact time of 12 h. 300 caregivers of young adults who have experienced first episode psychosis within last 3 years will be recruited. Program effectiveness will be assessed by comparing outcomes measuring the caregivers' burden, mental health symptoms, positive well-being, and the young adult's mental health symptoms during the study and at 9-month post-randomization. The role of expressed emotions, interpersonal mindfulness, and non-attachment in mediating these outcomes will be explored. An additional qualitative approach Photovoice is selected to explore the complex family experiences and the benefits of mindfulness from the caregivers' personal perspectives. Trial Registration: The trial is registered with the United States Clinical Trials Registry (ClinicalTrials.gov): NCT03688009.

Noneffectiveness of electroacupuncture for comorbid generalized anxiety disorder and irritable bowel syndrome.

BACKGROUND AND AIM: Comorbid generalized anxiety disorder and irritable bowel syndrome are common and therapeutically challenging. We aimed to assess the effectiveness of electroacupuncture in relieving anxiety and bowel symptoms in Chinese adults with this form of comorbidity. METHODS: In a single-blind randomized sham-controlled trial, subjects with comorbid generalized anxiety disorder and irritable bowel syndrome were randomly assigned to receive 10 weekly sessions of electroacupuncture or sham electroacupuncture. Patients were assessed at baseline, immediately after intervention and at 6-week follow-up. Primary outcome was anxiety (7-item Patient Health Questionnaire section for anxiety). Secondary outcomes included bowel symptoms (bowel symptoms questionnaire), depressive symptoms (9-item Patient Health Questionnaire), somatic symptoms (15-item Patient Health Questionnaire), and health-related quality of life (EuroQol-5 Dimensions). RESULTS: Eighty subjects, 40 in each arm, were randomized. All but two in the sham group completed 10 weekly sessions. There was no significant difference in the proportion of patients experiencing significant (≥ 50%) reduction of anxiety symptoms between the two groups immediately after intervention (32.4% vs 21.6%, P = 0.06) and at 6-week follow-up (25.7% in electroacupuncture vs 27% in sham, P = 0.65). Anxiety, depressive symptom, and bowel symptom severity did not differ significantly between electroacupuncture and sham groups. CONCLUSIONS: Findings failed to support the effectiveness of electroacupuncture for comorbid generalized anxiety disorder and irritable bowel syndrome. Further studies are needed to identify effective acupuncture treatment protocols for such comorbidity.

Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial.

INTRODUCTION: Mindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervention for children with ADHD and their respective parents through a robust research design. METHODS AND ANALYSIS: This study will adopt a randomised controlled trial design including 140 children aged 8-12 years with ADHD together with one of their parents (n=140). These families will be randomised into intervention group (n=70) who will be offered the MYmind programme delivered by trained healthcare professionals, and an active control group (n=70) who will be offered the CBT programme. The intervention includes 8 weekly 90 min group sessions for children with ADHD (aged 8-12 years) and their respective parents. The primary and secondary outcomes will include children's attention, ADHD-related symptoms, behaviours, executive function and mindfulness levels measured by validated objective measures and parent's reported instruments. Parents' parental stress, parenting styles, ADHD related symptoms, well-being, rumination level and mindfulness levels will also be measured. Analysis is by intention to treat. The effects of intervention will be evaluated by comparing outcomes between the two arms, as well as comparing outcomes within subject through comparing measurements at baseline (T0), immediately after the 8 week intervention (T1) and at 3 (T2) and 6 (T3) months postintervention. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC). Participants will be required to sign informed consent form from both parents and children. Findings will be reported in conferences and peer-reviewed publications in accordance with recommendations of Consolidated Standards of Reporting Trials. TRIAL REGISTRATION NUMBER: ChiCTR1800014741; Pre-results.

Trial Protocol: The use of mindfulness-based intervention for improving bracing compliance for adolescent idiopathic scoliosis patients: protocol for a randomised, controlled trial.

INTRODUCTION: Adolescent idiopathic scoliosis (AIS) is the most prevalent deforming orthopaedic condition; it causes significant disability when spinal curves progress beyond 45deg. Bracing is the primary treatment prescribed for adolescents with an immature skeleton who have spinal curves between 25 and 45deg. New evidence suggests that compliance with bracing significantly decreases the progression of high-risk curves to the threshold for surgery. Nonetheless, bracing is a stressful experience. Therefore, interventions that mediate health-related quality of life for AIS patients are of great interest. In the past few decades, numerous studies have documented the benefits of mindfulness training on chronic pain, stress management, anxiety and emotional disorders. Mindfulness might additionally provide AIS patients with psychosocial support. RESEARCH QUESTIONS: This study will investigate the effects of a mindfulness-based intervention on bracing compliance and quality of life among AIS patients with poor bracing compliance. The study also plans to evaluate if the mindfulness-based intervention effect is sustained after the intervention period. The potential mechanism by which mindfulness affects bracing compliance will be explored. DESIGN: Single-blind, two-arm, randomised, controlled trial. PARTICIPANTS AND SETTING: The study will recruit 120 AIS patients aged between 10 and 15 years with non-satisfactory bracing compliance. Patients who have previously practised or are currently practising meditation or mindful yoga or who cannot finish the whole intervention will be excluded. The study will take place at the Jockey Club School of Public Health and Primary Care building. INTERVENTION: Patients in the mindfulness-based intervention group will join weekly sessions for 8 weeks. This program is a short version of a mindfulness-based stress relaxation program to address the specific issues of AIS patients. Two to three experienced instructors will deliver the program. CONTROL: Control group patients will participate in an 8-week physiotherapy exercise program as recommended in the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) 2011 guideline. MEASUREMENTS: The primary outcome is the 6-month post-intervention total score of bracing compliance. Secondary measures are non-bracing-specific quality of life, bracing-specific quality of life, self-compassion, emotional regulation, mindful awareness and acceptance, self-efficacy, perception of stress, and general measure of health outcome. PROCEDURE: 120 participants will be assigned to either an intervention or control arm by simple randomisation, and the randomisation result will only be revealed once participants have confirmed availability to attend intervention classes. Clinicians of the scoliosis clinic and research staff will be blinded to the treatment allocation. ANALYSIS: ANCOVA will be conducted to compare the effect of mindfulness-based intervention versus physiotherapy exercise on the outcome measures. To investigate significant change over time, linear mixed models analyses will be conducted following the intention-to-treat principle. The R-package lavaan will be used to conduct structural equation modelling to study the potential mechanism of mindfulness. DISCUSSION/SIGNIFICANCE: This will be the first psychosocial intervention study conducted on braced AIS patients with the aim of improving patients' bracing compliance and quality of life. The results from this study will potentially carry significant impact on future AIS treatment by emphasising psychosocial care for braced AIS patients.

Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial.

BACKGROUND: Knee Osteoarthritis (KOA) is a very common condition with prevalence rising with age. It is a major contributor to global disability and has a large socioeconomic burden worldwide. Conservative therapies have marginal effectiveness, and surgery is reserved for severe symptomatic KOA. Dextrose Prolotherapy (DPT) is an evidence-based injection-based therapy for chronic musculoskeletal conditions including KOA. The standard "whole joint" injection method includes intra-articular injection and multiple extra-articular injections at soft tissue bony attachments. The procedure is painful and requires intensive procedural training often unavailable in conventional medical education, which potentially limits access. Intra-articular injection offers the possibility of a less painful, more accessible treatment. The aim of this project is to assess the clinical efficacy of intra-articular injection of DPT versus normal saline (NS) for KOA. METHOD: Seventy-six participants with KOA will be recruited from the community. We will conduct a single center, parallel group, superiority randomized controlled trial comparing DPT and NS injections, with blinding of physician, participants, outcome assessors and statisticians. Each group will receive injections at week 0, 4, 8 and 16. The primary outcome will be the Western Ontario McMaster University Osteoarthritis Index pain scale (WOMAC), and secondary outcomes include WOMAC composite score, the WOMAC function and stiffness subscale, the Visual Analogue Score of pain, objective physical function tests (the 30 s chair stand, 40- m fast paced walk test, the Timed up and go test) and the EuroQol-5D (EQ-5D). All outcomes will be evaluated at baseline, and 16, 26 and 52 weeks. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models. DISCUSSION: This paper presents the rationale, design, method and operational aspects of the trial. The findings will determine whether IA DPT, an inexpensive and simple injection, is a safe and effective non-surgical option for KOA. The results can be translated directly to clinical practice, with potentially substantial impact to patient care. TRIAL REGISTRATION: The trial ( ChiCTR-IPC-15006617 ) is registered under Chinese Clinical Trials Registry on 17th June 2015.