Designing an intervention process that embeds work-focussed interventions within inpatient rehabilitation: An intervention mapping approach.

INTRODUCTION: Returning to work is a goal for many people after brain injury. The failure to return to work after injury brings both economic and personal (quality of life) costs to those living with stroke or brain injury, their families, and society. This study explored the barriers to providing work-focused interventions during hospital-based rehabilitation and co-created solutions with rehabilitation providers to increase the provision of work-focused intervention during inpatient rehabilitation. METHODS: This study used an Intervention Mapping approach (a six-step protocol that guides the design of complex interventions) based on an action research methodology. Focus group data, in addition to best evidence from systematic reviews, practice guidelines and key articles were combined with theoretical models for changing behaviour and clinician experience. This was then systematically operationalised into an intervention process using consensus among clinicians. The process was further refined through piloting and feedback from key stakeholders, and group consensus on the final process. RESULTS: A detailed five phase return to work intervention process for inpatient rehabilitation was developed. The key features of the process include; having one key allied health clinician to coordinate the process, choosing assessments based on pre-injury work demands, emphasising the importance of core work skills and considering the most appropriate service for referral at the conclusion of rehabilitation. CONCLUSION: We used a systematic approach, guided by the intervention mapping approach and behaviour change theory to tailor existing workfocused interventions to the inpatient setting.

A randomized controlled trial investigating the effects of PCSO-524, a patented oil extract of the New Zealand green lipped mussel (Perna canaliculus), on the behaviour, mood, cognition and neurophysiology of children and adolescents (aged 6-14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN12610000978066.

BACKGROUND: The prevalence rate of attention-deficit/hyperactivity disorder (ADHD) within Western cultures is between 5% and 12%, and is the most common psychiatric illness among school-aged children, with an estimated 50% of these children retaining ADHD symptoms for the rest of their lives. Children with ADHD have lower blood levels of long-chain Poly Unsaturated Fatty Acids (LC PUFAs) compared with children without ADHD, and following PUFA supplementation, have shown improvements in ADHD-related symptoms. One highly promising marine based LC PUFA preparation is the Omega-3-rich Lyprinol/Omega XL which is a natural formulation containing standardised lipid extract of the New Zealand green lipped mussel (Perna canaliculus) known as PCSO-524® which contains a unique combination of free fatty acids, sterol esters, polar lipids and carotenoids. It is this unique combination of marine lipids that may assist in correcting the decreased levels of LC PUFA levels in children with symptoms of ADHD. The compound is a mixture belonging to a lipid group called sterol esters (SE). The fatty acids in the SE fraction are mainly myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Lyprinol/Omega XL has previously been shown to contain a potent group of Omega-3 lipids that block the 5 - lipoxygenase metabolic pathway responsible for inflammation in the body. METHODS: A randomized double blind placebo controlled trial will be utilized to assess the effects of 14 weeks administration of Lyprinol/Omega XL versus placebo in 150 children aged 6 to 14 years with high levels of hyperactivity and inattention. Additionally, a range of cognitive, mood and central electrophysiological measures will be undertaken during the 14 week supplementation trial. The primary outcome measure, the Conners' Parent Rating Scales will be completed initially at baseline, then in weeks 4, 8, 10, 14 and then again at 4 weeks post-administration (week 18). The results will contribute to our understanding of the efficacy of marine based Omega-3 s with high anti-inflammatory actions on inattention and hyperactivity in children aged 6 to 14 years.

Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial.

BACKGROUND: While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. METHODS: Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers) was employed to ensure methodological rigour. Participant's experiences were categorised as "positive" or "negative" and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender). Usual experiences were categorised and discussed separately. RESULTS: Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022) and enhanced mood (p=.027). The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin group having minor digestive complaints. CONCLUSION: This represents the first documented qualitative investigation of participants' experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being. TRIAL REGISTRATION: Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au) ACTRN12611000092998.

Behavioural effects of a 10-day Mediterranean diet. Results from a pilot study evaluating mood and cognitive performance.

There are surprisingly few randomised, controlled trials into the effects of dietary change on mood and cognition in healthy individuals. Here we examined the effects of 10 days of changing to a nutrient-rich diet on mood and cognitive performance. Young female adults (N=25) were randomised to a diet change (DC), or a no change (NC) control group. Those in the DC condition adhered to the nutrient-dense Mediterranean diet. Mood and cognitive performance were assessed at baseline and on day 10. Compared with the NC group, the DC group showed significant improvements in self-rated vigour, alertness and contentment. Changes in cognitive tasks were somewhat inconsistent. These preliminary findings require verification in larger trials but suggest that appropriate dietary change may benefit mood and some aspects of cognitive performance in healthy adults.

Evidence that anhedonia is a symptom of opioid dependence associated with recent use.

BACKGROUND: Anhedonia is prevalent among substance-dependent populations. The hedonic allostasis model suggests this is due to the effects of addictive substances on neural substrates of reward processing. However, previous research may have been confounded by other factors likely to influence anhedonia, including tobacco use, psychopathology, and history of trauma and other stressors. Thus it remains unclear whether elevated anhedonia in substance-dependent populations is caused by substance use itself, or is due to other correlates of substance dependence. METHODS: Multivariate analysis of covariance was conducted to test whether opioid-dependent participants' anhedonia scores were elevated, relative to a non-dependent control group, after controlling for psychosocial factors likely to influence anhedonia. Correlational analyses within opioid-dependent participants were also conducted to examine whether anhedonia was associated with recent illicit opioid use or duration of abstinence. RESULTS: There was a modest, but significant, elevation in anhedonia in opioid-dependent participants, relative to controls (Partial η2=0.034, p=0.041) after controlling for psychosocial variables that were associated with anhedonia. Depressive symptoms and history of post-traumatic stress disorder also remained significantly associated with anhedonia in the adjusted model. Among participants on opioid pharmacotherapy, there were significant associations between frequency of recent illicit opioid use and scores on anhedonia measures (all rs>0.25, p<0.013), but among abstinent opioid-dependent participants, relationships between duration of abstinence and anhedonia were not significant (all rs<0.24, p>0.22). CONCLUSION: These findings support the hypothesis that use of opioids can cause anhedonia, although other psychosocial factors may also contribute to the high prevalence of anhedonia among opioid-dependent populations.

Anti-stress effects of lemon balm-containing foods.

Lemon balm (Melissa officinalis) has been used historically and contemporarily as a modulator of mood and cognitive function, with anxiolytic effects following administration of capsules, coated tablets and topical application. Following a pilot study with lemon balm extract administered as a water based drink, which confirmed absorption of rosmarinic acid effects on mood and cognitive function, we conducted two similar double-blind, placebo-controlled, crossover studies. These evaluated the mood and cognitive effects of a standardised M. officinalis preparation administered in palatable forms in a beverage and in yoghurt. In each study a cohort of healthy young adults' self-rated aspects of mood were measured before and after a multi-tasking framework (MTF) administered one hour and three hours following one of four treatments. Both active lemon balm treatments were generally associated with improvements in mood and/or cognitive performance, though there were some behavioral "costs" at other doses and these effects depended to some degree on the delivery matrix.

Cocoa polyphenols enhance positive mood states but not cognitive performance: a randomized, placebo-controlled trial.

This study aimed to examine the acute and sub-chronic effects of cocoa polyphenols on cognition and mood. In a randomized, double-blind study, healthy middle-aged participants received a dark chocolate drink mix standardized to contain 500 mg, 250 mg or 0 mg of polyphenols (placebo) in a parallel-groups design. Participants consumed their assigned treatment once daily for 30 days. Cognition was measured with the Cognitive Drug Research system and self-rated mood with the Bond-Lader Visual Analogue Scale. Participants were tested at baseline, at 1, 2.5 and 4 h after a single acute dose and again after receiving 30 days of treatment. In total, 72 participants completed the trial. After 30 days, the high dose of treatment significantly increased self-rated calmness and contentedness relative to placebo. Mood was unchanged by treatment acutely while cognition was unaffected by treatment at all time points. This randomized controlled trial is perhaps the first to demonstrate the positive effects of cocoa polyphenols on mood in healthy participants. This provides a rationale for exploring whether cocoa polyphenols can ameliorate the symptoms associated with clinical anxiety or depression.

The effects of multivitamin supplementation on diurnal cortisol secretion and perceived stress.

Recent evidence suggests that dietary intake of vitamins, in particular the B-vitamins including B6, B9 and B12 may have a number of positive effects on mood and stress. Given the effects of stress on a range of biological mechanisms including the endocrine system, it could be reasonably expected that multivitamin supplementation may also affect markers of these mechanisms such as diurnal cortisol secretion. In the current double-blind placebo-controlled study 138 adults (aged 20 to 50 years) were administered a multivitamin containing B-vitamins versus placebo over a 16-week period. Salivary cortisol measurements were taken at waking, 15-min, 30-min and at bedtime, at baseline, 8-weeks and 16-weeks. Perceived Stress (PSS) was measured at baseline, 8-weeks and 16-weeks, while blood serum measures of B6, B12 and homocysteine (HCy) as well as red cell folate (B9) were also collected at these time points. A significant interaction was found between treatment group and study visit for the Cortisol Awakening Response (CAR). Compared to placebo, at 16-weeks multivitamin supplementation was found to be associated with a near-significant trend towards an increased CAR. No significant differences in PSS were found between groups, with PSS increasing in both groups across the course of the study. Red cell folate was found to be significantly correlated with the CAR response at 16-weeks while HCy levels were not found to be associated with the CAR response, although HCy significantly correlated with waking cortisol levels at 8-weeks. A possible interpretation of the elevation in CAR associated with multivitamin supplementation is that this represents an adaptive response to everyday demands in healthy participants.

Healthy middle-aged individuals are vulnerable to cognitive deficits as a result of increased arterial stiffness.

OBJECTIVES: Whilst pulse pressure and pulse wave velocity have been shown to predict cognitive outcomes, the relationship between arterial stiffness and cognition has not yet been explored in an entirely healthy nonclinical population. Furthermore, the effects of arterial stiffness on cognition are yet to be examined with computerized cognitive test batteries sensitive to subtle differences in cognitive performance. The aim of the present study was to examine the relationship between arterial stiffness (pulse pressure and augmentation index) and specific domains of cognitive performance in a healthy middle-aged sample. INDIVIDUALS AND METHOD: The sample comprised 92 healthy individuals, aged between 40 and 65 years, with no history of cardiovascular disease, diabetes, stroke, hypertension, smoking and were free from medication. The cognitive drug research (CDR) computerized system was implemented to assess domains of cognitive performance, whereas pulse pressure and augmentation index were determined centrally by a noninvasive SphygmoCor device. RESULTS: Pulse pressure was an independent predictor of both episodic secondary memory performance (beta = -0.27, R change = 0.07, P < 0.05) and speed of memory retrieval (beta = 0.24, R change = 0.06, P < 0.05). Augmentation index was also an independent predictor of speed of memory (beta = 0.27, R change = 0.07, P < 0.01). Working memory, power of attention and continuity of attention were not predicted by pulse pressure or augmentation index. CONCLUSION: It was concluded that healthy middle-aged adults are vulnerable to memory deficits as a result of normal increases in pulse pressure associated with ageing.