Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial.

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma.

PURPOSE: This study assessed the feasibility and acceptability of an online mindfulness-based intervention (MBI) for people diagnosed with melanoma. The potential benefit of the MBI on fear of cancer recurrence (FCR), worry, rumination, perceived stress and trait mindfulness was also explored. METHODS: Participants who have completed treatment for stage 2c or 3 melanoma were recruited from an outpatient clinic and randomly allocated to either the online MBI (intervention) or usual care (control). The 6-week online MBI comprised short videos, daily guided meditations and automated email reminders. Participants were asked to complete questionnaires at baseline and at 6-week post-randomisation. Study feasibility and acceptability were assessed through recruitment rates, retention and participant feedback. Clinical and psychosocial outcomes were compared between groups using linear mixed models. RESULTS: Sixty-nine (58%) eligible participants were randomised (46 in the intervention; 23 in the control group); mean age was 53.4 (SD 13.1); 54% were female. Study completion rate across both arms was 80%. The intervention was found helpful by 72% of the 32 respondents. The intervention significantly reduced the severity of FCR compared to the control group (mean difference = - 2.55; 95% CI - 4.43, - 0.67; p = 0.008). There was no difference between the intervention and control groups on any of the outcome measures. CONCLUSIONS: This online MBI was feasible and acceptable by people at high risk of melanoma recurrence. It significantly reduced FCR severity in this sample. Patients valued accessing the program at their own pace and convenience. This self-guided intervention has the potential to help survivors cope with emotional difficulties. An adequately powered randomised controlled trial to test study findings is warranted.

Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review.

BACKGROUND: Internet-supported mindfulness-based interventions (MBIs) are increasingly being used to support people with a chronic condition. Characteristics of MBIs vary greatly in their mode of delivery, communication patterns, level of facilitator involvement, intervention period, and resource intensity, making it difficult to compare how individual digital features may optimize intervention adherence and outcomes. OBJECTIVE: The aims of this review were to (1) provide a description of digital characteristics of internet-supported MBIs and examine how these relate to evidence for efficacy and adherence to the intervention and (2) gain insights into the type of information available to inform translation of internet-supported MBIs to applied settings. METHODS: MEDLINE Complete, PsycINFO, and CINAHL databases were searched for studies assessing an MBI delivered or accessed via the internet and engaging participants in daily mindfulness-based activities such as mindfulness meditations and informal mindfulness practices. Only studies using a comparison group of alternative interventions (active compactor), usual care, or wait-list were included. Given the broad definition of chronic conditions, specific conditions were not included in the original search to maximize results. The search resulted in 958 articles, from which 11 articles describing 10 interventions met the inclusion criteria. RESULTS: Internet-supported MBIs were more effective than usual care or wait-list groups, and self-guided interventions were as effective as facilitator-guided interventions. Findings were informed mainly by female participants. Adherence to interventions was inconsistently defined and prevented robust comparison between studies. Reporting of factors associated with intervention dissemination, such as population representativeness, program adoption and maintenance, and costs, was rare. CONCLUSIONS: More comprehensive descriptions of digital characteristics need to be reported to further our understanding of features that may influence engagement and behavior change and to improve the reproducibility of MBIs. Gender differences in determinants and patterns of health behavior should be taken into account at the intervention design stage to accommodate male and female preferences. Future research could compare MBIs with established evidence-based therapies to identify the population groups that would benefit most from internet-supported programs. TRIAL REGISTRATION: PROSPERO CRD42017078665; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=78665 (Archived by WebCite at http://www.webcitation.org/71ountJpu).

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.

BACKGROUND: People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial. METHODS/DESIGN: This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments. DISCUSSION: This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.

Systematic review of meditation-based interventions for children with ADHD.

Meditation-based interventions such as mindfulness and yoga are commonly practiced in the general community to improve mental and physical health. Parents, teachers and healthcare providers are also increasingly using such interventions with children. This review examines the use of meditation-based interventions in the treatment of children with Attention-Deficit Hyperactivity Disorder (ADHD). Electronic databases searched included PsycINFO, Medline, CINAHL, and AMED. Inclusion criteria involved children (aged to 18 years) diagnosed with ADHD, delivery of a meditation-based intervention to children and/or parents, and publication in a peer-reviewed journal. Studies were identified and coded using standard criteria, risk of bias was assessed using Risk of Bias in Non-randomised Studies- of interventions (ROBINS-I), and effect sizes were calculated. A total of 16 studies were identified (8 that included children in treatment, and 8 that included combined parent-child treatment). Results indicated that risk of bias was high across studies. At this stage, no definitive conclusions can be offered regarding the utility of meditation-based interventions for children with ADHD and/or their parents, since the methodological quality of the studies reviewed is low. Future well designed research is needed to establish the efficacy of meditation-based interventions, including commonly used practices such as mindfulness, before recommendations can be made for children with ADHD and their families.

Prevalence of mental health disorders in inflammatory bowel disease: an Australian outpatient cohort.

BACKGROUND: This study aimed to characterize prevalence of anxiety and depressive conditions and uptake of mental health services in an Australian inflammatory bowel disease (IBD) outpatient setting. METHODS: Eighty-one IBD patients (39 males, mean age 35 years) attending a tertiary hospital IBD outpatient clinic participated in this study. Disease severity was evaluated according to the Manitoba Index. Diagnosis of an anxiety or depressive condition was based upon the Mini-International Neuropsychiatric Interview and the Hospital Anxiety and Depression Scale. RESULTS: Based on Hospital Anxiety and Depression Scale subscale scores >8 and meeting Mini-International Neuropsychiatric Interview criteria, 16 (19.8%) participants had at least one anxiety condition, while nine (11.1%) had a depressive disorder present. Active IBD status was associated with higher prevalence rates across all anxiety and depressive conditions. Generalized anxiety was the most common (12 participants, 14.8%) anxiety condition, and major depressive disorder (recurrent) was the most common depressive condition reported (five participants, 6.2%). Seventeen participants (21%) reported currently seeking help for mental health issues while 12.4% were identified has having at least one psychological condition but not seeking treatment. CONCLUSION: We conclude that rates of anxiety and depression are high in this cohort, and that IBD-focused psychological services should be a key component of any holistic IBD service, especially for those identified as having active IBD.

Observable essential fatty acid deficiency markers and autism spectrum disorder.

Autism Spectrum Disorder (ASD) has been associated with essential fatty acid (EFA) deficiencies, with some researchers theorising that dysregulation of phospholipid metabolism may form part of the biological basis for ASD. This pilot study compared observable signs of fatty acid status of 19 children with an ASD diagnosis to 23 of their typically developing siblings. A pregnancy, birth and breastfeeding history was also obtained from their parents, which included a measure of infant intake of fatty acid rich colostrum immediately post-partum. When considered within their family group, those infants not breastfed (with colostrum) within the first hour of life and who had a history of fatty acid deficiency symptoms were more likely to have an ASD diagnosis. Other variables such as formula use, duration of breastfeeding, gestational age and Apgar scores were not associated with group membership. The results of this study are consistent with previous research showing a relationship between fatty acid metabolism, breastfeeding and ASD such that early infant feeding practices and the influence this has on the fatty acid metabolism of the child may be a risk factor for ASD.

Managing panic disorder in general practice.

BACKGROUND: Panic disorder (PD) is common in the community and contributes to significant distress and decreased quality of life for people who suffer from it. Most people with PD will present in the first instance to their general practitioner or hospital emergency department for assistance, often with a focus on somatic symptoms and concerns. OBJECTIVE: This article aims to assist the GP to manage this group of patients by providing an outline of aetiology, approaches to assessment, and common management strategies. DISCUSSION Although GPs have an important role to play in ruling out any causal organic basis for panic symptoms, the diagnosis of PD can usually be made as a positive diagnosis on the basis of careful history taking. Thorough and empathic education is a vital step in management. The prognosis for PD can be improved by lifestyle changes, specific psychological techniques, and the judicious use of pharmacotherapy.

Increased anti-P-glycoprotein activity of baicalein by alkylation on the A ring.

The aqueous extract of Scutellariae baicalensis Georgi has inhibitory activity against P-gp 170, a multiple drug resistant gene product. Baicalein, one of the major flavones, was found to be responsible for this activity. The hydroxyl groups of the A ring of baicalein were systematically alkylated in order to assess the effect of such modifications on the activity against P-gp 170. The impact of the baicalein modifications on activity against the growth of a human nasopharyngeal cancer cell line KB and its P-gp 170 overexpressing cell line KB/MDR were also examined. The results indicate that alkylation of R5 of baicalein does not have a major impact on the interaction with P-gp 170, whereas alkylation of R6 or R7 alone or both, could enhance the interaction of baicalein with P-gp 170 as well as the amount of intracellular accumulation of vinblastine, a surrogate marker for the activity of P-gp 170 pump of KB/MDR cells. In this case, the optimal linear alkyl functionality is a propyl side chain. These modifications could also alter the activity of compounds inhibiting cell growth. Among the different compounds synthesized, the most potent molecule against P-gp 170 is 5-methoxy-6,7-dipropyloxyflavone (23). Its inhibitory activity against P-gp 170 is approximately 40 times better, based on EC50 (concentration of the compound enhancing 50% of the intracellular vinblastine accumulation in the KB/MDR cells) and 3 times higher, based on Amax (the intracellular vinblastine accumulation of the KB/MDR cells caused by the compound) as compared to baicalein. Compound 23 is also a more selective inhibitor than baicalein against P-gp 170, because its cytotoxicity is less than that observed for baicalein. The growth inhibitory IC50 of compound 23 against KB and KB/MDR cells are about the same, suggesting that compound 23 is unlikely to be a substrate of P-gp 170 pump. Acetylation of R6, R7 or both could also decrease EC50 and increase Amax. Acetylated compounds are more toxic than baicalein, and their potency against cell growth is compromised by the presence of P-gp 170, suggesting that these compounds are substrates of P-gp 170. Benzylation of R6 or R7 but not both also enhanced anti-P-gp170 activity and potency against cell growth; however, the presence of P-gp 170 in cells did not have an impact on their sensitivity to these molecules, suggesting that the benzylated compounds are inhibitors but not substrates of P-gp 170, and perhaps have a different mechanism of action. In conclusion, the substitutions of R6 and R7 hydroxyl groups by alkoxy groups, acetoxy groups, or benzyloxy groups could yield compounds with different modes of action against P-gp 170 with different mechanisms of action against cell growth.