A randomized, double-blind, placebo-controlled trial investigating the effects of an Ocimum tenuiflorum (Holy Basil) extract (HolixerTM) on stress, mood, and sleep in adults experiencing stress

Background: In Ayurveda, Ocimum tenuiflorum (Holy Basil) is referred to as “the elixir of life” and is believed to promote longevity and general wellbeing. Although limited, there are clinical trials to suggest Ocimum tenuiflorum has anti-stress effects. Purpose: Examine the effects of a standardized Ocimum tenuiflorum extract (HolixerTM) on subjective and objective measures of stress and sleep quality in adults experiencing stress. Study design: Two-arm, parallel-group, 8-week, randomized, double-blind, placebo-controlled trial. Australian and New Zealand Clinical Trials Registry trial registration number ACTRN12621000609853. Methods: One hundred volunteers aged 18–65 years received either 125 mg of Ocimum tenuiflorum twice daily or a placebo. Outcome measures included the Perceived Stress Scale (PSS) (primary outcome measure), Profile of Mood States, Athens Insomnia Scale (AIS), Restorative Sleep Questionnaire, and the Patient-Reported Outcomes Measurement Information System-29. Sleep quality was also assessed using a wrist-worn sleep tracker (Fitbit), and stress changes were examined by measuring between-group differences in hair cortisol and stress responses after exposure to an experiment stress procedure known as the Maastricht Acute Stress Test (MAST). Results: Compared to the placebo, Ocimum tenuiflorum supplementation was associated with greater improvements in PSS (p = 0.003) and AIS (p = 0.025) scores; and at week 8, concentrations in hair cortisol were also lower (p = 0.025). Moreover, Ocimum tenuiflorum supplementation was associated with a buffered stress responses after exposure to the MAST as demonstrated by significantly lower concentrations in salivary cortisol (p = 0.001), salivary amylase (p = 0.001), systolic (p = 0.010) and diastolic (p = 0.025) blood pressure, and subjective stress ratings (p < 0.001). Ocimum tenuiflorum supplementation was well-tolerated with no reports of major adverse effects. Conclusion: The results from this trial suggest that 8 weeks of supplementation with an Ocimum tenuiflorum extract (HolixerTM) may reduce objective and subjective measures of stress, and improve subjective measures of sleep quality. However, further research using gold-standard objective sleep measures will be required to substantiate the sleep-related findings

The feasibility and efficacy of a brief integrative treatment for adults with depression and/or anxiety: A randomized controlled trial

The aim of this study was to investigate the efficacy and suitability of a brief integrative intervention, Personalized Integrative Therapy (PI Therapy), for the treatment of adult depression and/or anxiety. In this 6-week, 3-arm, parallel-group, randomized trial, PI Therapy delivered alone or with nutritional supplements (PI Therapy + Supps) was compared to cognitive behavior therapy (CBT) in 48 adults with depression and/or anxiety. All treatments were delivered as a 1-day workshop plus 6 weeks of reminder phone text messages to reinforce topics and skills covered in the workshop. Affective symptoms decreased significantly and to the same extent in all 3 conditions. At the end of treatment, 33% to 58% of participants reported levels of depressive symptoms in the normal range, and 50% to 58% reported nonclinical levels of anxiety. Compared to CBT and PI Therapy, PI Therapy + Supps was associated with significantly greater improvements in sleep quality. These findings suggest that a brief integrative intervention with or without supplements was comparable to CBT in reducing affective symptoms in adults with depression and/or anxiety. However, sleep quality improved only in the PI Therapy + Supps condition. These findings will require replication with a larger cohort

Factors associated with retention in a smoking cessation trial for persons with a mental illness: A descriptive study

Background Exploring factors associated with retention in randomised trials provides insight into potential threats to internal and external study validity, and may inform the development of interventions to increase retention in future trials. Given a paucity of existing research in the field, a study was conducted to explore factors associated with retention in a smoking intervention trial involving persons with a mental illness, considering demographic and smoking characteristics, treatment condition and engagement in prior follow-up assessments. Method A descriptive study was undertaken using data derived from a RCT of a smoking cessation intervention initiated in four adult psychiatric inpatient units in New South Wales (NSW), Australia. Retention assessment was undertaken at 1, 6 and 12-months post-discharge. A Generalised Linear Mixed Model was adopted to explore associations between retention at any follow up time point and demographic and smoking characteristics. Chi square analyses explored the association between retention at all follow up time points and treatment condition, and binary logistic regression analyses assessed for relationships between retention at 12-month follow up and engagement in prior follow up assessments. Results Retention rates were 63, 56 and 60% at the 1, 6 and 12-month assessments, respectively. No association was found between retention at any follow-up time point and 13 of 15 demographic and smoking characteristics. Younger participants and those who identified to be Aboriginal and/or Torres Strait Islander were more likely to be retained (both ps > 0.05). Retention rates did not vary according to treatment condition at any follow-up time point. Participants who completed a prior assessment were more likely to complete the 12 month assessment (both prior assessments: OR 10.7, p < 0.001; 6 month assessment: OR 6.01, p < 0.001; and 1 month assessment: OR 1.8, p = 0.002). Conclusion The underrepresentation of younger participants and those identifying to be Aboriginal and/or Torres Strait Islander may limit the generalisability of findings. Findings suggest that inclusion of multiple contacts during a trial follow up period may increase retention at the final assessment. Interventions to improve retention, overall and for those sub-groups less likely to be retained, in smoking trials involving persons with a mental illness are needed. Further assessment of sample characteristics, and also trial design factors, associated with retention in this field is warranted

Effects of a Bacopa monnieri extract (Bacognize®) on stress, fatigue, quality of life and sleep in adults with self-reported poor sleep: A randomised, double-blind, placebo-controlled study

In this 28-day, randomised, double-blind, placebo-controlled trial, 100 adults with self-reported poor sleep received either a placebo or a standardised Bacopa monnieri extract (150 mg twice daily). Outcome measures included the Bergen Insomnia Scale (primary outcome measure), Functional Outcomes of Sleep Questionnaire, Pittsburgh Sleep Diary, Short Form-36 Health Survey, and the Depression, Anxiety, and Stress Scale. Changes in salivary concentrations of cortisol, dehydroepiandrosterone sulfate, immunoglobulin A (sIgA), α-amylase (sAA), C-reactive protein, melatonin, and the fatigue biomarker index were also assessed. Based on the Bergen Insomnia Scale, Bacopa monnieri did not improve sleep patterns more than the placebo; however, it was associated with greater improvements in emotional wellbeing, general health, and pain-related symptoms. Bacopa monnieri was also associated with greater reductions in sIgA and sAA compared to the placebo. Future clinical trials using varying doses, treatment periods, and objective outcome measures will be important to validate these findings

Self-reported suboptimal sleep and receipt of sleep assessment and treatment among persons with and without a mental health condition in Australia: a cross sectional study

Background Poor sleep and poor mental health go hand in hand and, together, can have an adverse impact on physical health. Given the already disproportionate physical health inequities experienced by people with a mental health condition worldwide, the need to consider and optimise sleep has been highlighted as a means of improving both physical and mental health status. Sleep recommendations recently developed by the United States’ National Sleep Foundation incorporate a range of sleep parameters and enable the identification of ‘suboptimal’ sleep. Among community-dwelling persons with and without a 12-month mental health condition in Australia, this study reports: [1] the prevalence of ‘suboptimal’ sleep and [2] rates of sleep assessment by a health care clinician/service and receipt of and desire for sleep treatment. Methods A descriptive study (N = 1265) was undertaken using self-report data derived from a cross-sectional telephone survey of Australian adults, undertaken in 2017. Results Fifteen per cent (n = 184) of participants identified as having a mental health condition in the past 12 months. Across most (7 of 8) sleep parameters, the prevalence of suboptimal sleep was higher among people with a mental health condition, compared to those without (all p < 0.05). The highest prevalence of suboptimal sleep for both groups was seen on measures of sleep duration (36–39% and 17–20% for people with and without a mental health condition, respectively). In terms of sleep assessment and treatment, people with a mental health condition were significantly more likely to: desire treatment (37% versus 16%), have been assessed (38% versus 12%) and have received treatment (30% versus 7%). Conclusions The prevalence of suboptimal sleep among persons with a mental health condition in Australia is significantly higher than those without such a condition, and rates of assessment and treatment are low for both groups, but higher for people with a mental health condition. Population health interventions, including those delivered as part of routine health care, addressing suboptimal sleep are needed

Uptake of smoking cessation aids by smokers with a mental illness

Psychiatric inpatient settings represent an opportunity to initiate the provision of tobacco cessation care to smokers with a mental illness. This study describes the use of evidence-based smoking cessation aids proactively and universally offered to a population of psychiatric inpatients upon discharge, and explores factors associated with their uptake. Data derived from the conduct of a randomised controlled trial were analysed in terms of the proportion of participants (N = 378) that utilised cessation aids including project delivered telephone smoking cessation counselling and nicotine replacement therapy (NRT), and Quitline support. Factors associated with uptake of cessation aids were explored using multivariable logistic regression analyses. A large proportion of smokers utilised project delivered cessation counselling calls (89 %) and NRT (79 %), while 11 % used the Quitline. The majority accepted more than seven project delivered telephone cessation counselling calls (52 %), and reported NRT use during more than half of their accepted calls (70 %). Older age, higher nicotine dependence, irregular smoking and seeing oneself as a non-smoker were associated with uptake of behavioural cessation aids. Higher nicotine dependence was similarly associated with use of pharmacological aids, as was NRT use whilst an inpatient. Most smokers with a mental illness took up a proactive offer of aids to support their stopping smoking. Consideration by service providers of factors associated with uptake may increase further the proportion of such smokers who use evidence-based cessation aids and consequently quit smoking successfully

Systematic review and meta-analysis of the provision of preventive care for modifiable chronic disease risk behaviours by mental health services

People with mental illness experience increased chronic disease burden, contributed to by a greater prevalence of modifiable chronic disease risk behaviours. Policies recommend mental health services provide preventive care for such risk behaviours. Provision of such care has not previously been synthesised. This review assessed the provision of preventive care for modifiable chronic disease risk behaviours by mental health services. Four databases were searched from 2006 to 2017. Eligible studies were observational quantitative study designs conducted in mental health services, where preventive care was provided to clients for tobacco smoking, harmful alcohol consumption, inadequate nutrition, or inadequate physical activity. Two reviewers independently screened studies, conducted data extraction and critical appraisal. Results were pooled as proportions of clients receiving or clinicians providing preventive care using random effects meta-analyses, by risk behaviour and preventive care element (ask/assess, advise, assist, arrange). Subgroup analyses were conducted by mental health service type (inpatient, outpatient, other/multiple). Narrative synthesis was used where meta-analysis was not possible. Thirty-eight studies were included with 26 amenable to meta-analyses. Analyses revealed that rates of assessment were highest for smoking (78%, 95% confidence interval [CI]:59%–96%) and lowest for nutrition (17%, 95% CI:1%–35%); with variable rates of care provision for all behaviours, care elements, and across service types, with substantial heterogeneity across analyses. Findings indicated suboptimal and variable provision of preventive care for modifiable chronic disease risk behaviours in mental health services, but should be considered with caution due to the very low quality of cumulative evidence

Rates of retention of persons with a mental health disorder in outpatient smoking cessation and reduction trials, and associated factors: Protocol for a systematic review and meta-analysis

Introduction Smoking among persons with a mental health disorder is associated with inequitable health, social and economic burden. Randomised controlled trials (RCTs) are considered the gold standard design for the assessment of healthcare intervention efficacy/effectiveness. However, many RCTs of smoking interventions for persons with a mental health disorder lack rigour due to low participant retention. No systematic review has pooled retention rates in randomised trials of smoking interventions for persons with a mental health disorder or explored associated factors. The aims of the systematic review will therefore be to: (1) summarise overall rates of participant retention in smoking cessation and reduction trials involving persons with a mental health disorder (including for experimental and control groups separately) and (2) determine if retention rates vary according to participant, environmental, researcher and study factors. Methods and analysis PsycINFO, EMBASE, MEDLINE, CENTRAL and The Cochrane Tobacco Addiction Review Group Specialised Register will be searched for reports of RCTs of outpatient smoking cessation or reduction interventions for adults with a mental health disorder. The search terms will include MeSH terms and free text words, and there will be no language or date restrictions. All databases will be searched from inception to present. Data will be analysed using the Mantel-Haenszel fixed-effect model, and where substantial heterogeneity (I2 >50%) is detected, DerSimonian & Laird inverse-variance random effects model. Pooled estimates and 95% CIs will be calculated for overall participant retention rates and for intervention and control trial arms separately. Associations between participant retention and participant, environmental, researcher and study factors will be assessed via subgroup analyses and, where sufficient data are obtained, meta-regression. Ethics and dissemination This study does not require ethical approval. The findings of this review will be disseminated via publication in a peer-reviewed open access medical journal and presentations at international scientific meetings

Prevalence of self-reported suboptimal sleep in Australia and receipt of sleep care: Results from the 2017 National Social Survey

Objectives The National Sleep Foundation’s (NSFs) sleep duration recommendations and quality indicators enable trichotomous classification of sleep parameters as ‘appropriate’, ‘may be appropriate’ or ‘inappropriate’, with the latter representing ‘suboptimal’ sleep. This study reports the prevalence of self-reported suboptimal sleep and associated demographics in a large sample of Australian adults. In addition, reported are rates of suboptimal sleep assessment by health-care clinicians/services and receipt of and desire for sleep care, and their associations with suboptimal sleep. Design/Setting/Participants A descriptive study (N = 1265) was undertaken using data derived from a cross-sectional telephone survey of Australian adults undertaken in 2017. Measurement/Analysis Descriptive statistics summarised the prevalence of suboptimal sleep, and chi-square and multivariable logistic regression analyses explored associations between suboptimal sleep, demographics and receipt of/interest in sleep care. Results Almost half of participants (42%) were considered to have suboptimal sleep: 19% met criteria on one parameter, 13% on 2, 11% on ≥3. The highest prevalence of suboptimal sleep was seen on measures of sleep duration (20%-23%). Participants who were single, female, middle-aged (26-64) and of low socioeconomic status were more likely to experience suboptimal sleep (p<0.01). Rates of assessment and treatment are currently suboptimal: 16% reported their sleep had been assessed and 10% received at least one element of sleep care, most commonly pharmacotherapy (43%). Conclusions Suboptimal sleep is prevalent in Australia, and rates of assessment and treatment are currently low. Finding supports the need for a coordinated population health strategy to improve the sleep health of Australians