Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial

BACKGROUND: Treatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments. METHODS: Data from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures. RESULTS: Ethics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P=.043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons. CONCLUSIONS: Olanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

Contact & connect-an intervention to reduce depression stigma and symptoms in construction workers: protocol for a randomised controlled trial

BACKGROUND: Males employed in the construction industry have high rates of suicide. Although reasons underpinning this risk are multifaceted, poor help-seeking and stigma are represent major contributors. Males in the construction industry are also exposed to other risk factors for mental ill health and suicide, including unemployment. Sigma-reducing interventions that are accessible and attractive to recently unemployed males in the construction industry could therefore improve help-seeking, and address depression and suicidal behaviour in this population. METHODS/DESIGN: Contact&Connect will use a parallel individual randomized design to evaluate the effectiveness of a multimedia-based intervention aimed at reducing stigma. The intervention consists of a package of 12 brief contact interventions (BCIs) delivered over a six month period. BCIs will direct participants to informational programs and microsites. Content will address three major themes: debunking depression myths and stereotypes, normalisation, and empowerment. Target enrolment is 630 (315 in each arm), each to be followed for 12 months. Eligible participants will be males, between 30 and 64 years, unemployed at the time of recruitment, registered with Incolink (a social welfare trustee company for unemployed members of the construction industry), and own a smart phone with enabled internet connectivity. DISCUSSION: At present, there are no programs that have been shown to be effective in reducing stigma in the blue-collar male population. Contact&Connect promises to provide a tailored, efficient, and scalable approach to reducing stigma, depressive symptoms and suicidality among unemployed males. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register ACTRN12615000792527  (date of registration: 30 July, 2015).

A single-blind, randomised controlled trial on the effects of lithium and quetiapine monotherapy on the trajectory of cognitive functioning in first episode mania: A 12-month follow-up study

BACKGROUND: Cognitive deficits have been reported during the early stages of bipolar disorder; however, the role of medication on such deficits remains unclear. The aim of this study was to compare the effects of lithium and quetiapine monotherapy on cognitive performance in people following first episode mania. METHODS: The design was a single-blind, randomised controlled trial on a cohort of 61 participants following first episode mania. Participants received either lithium or quetiapine monotherapy as maintenance treatment over a 12-month follow-up period. The groups were compared on performance outcomes using an extensive cognitive assessment battery conducted at baseline, month 3 and month 12 follow-up time-points. RESULTS: There was a significant interaction between group and time in phonemic fluency at the 3-month and 12-month endpoints, reflecting greater improvements in performance in lithium-treated participants relative to quetiapine-treated participants. After controlling for multiple comparisons, there were no other significant interactions between group and time for other measures of cognition. CONCLUSION: Although the effects of lithium and quetiapine treatment were similar for most cognitive domains, the findings imply that early initiation of lithium treatment may benefit the trajectory of cognition, specifically verbal fluency in young people with bipolar disorder. Given that cognition is a major symptomatic domain of bipolar disorder and has substantive effects on general functioning, the ability to influence the trajectory of cognitive change is of considerable clinical importance.

Improving the implementation of responsible alcohol management practices by community sporting clubs: A randomised controlled trial

INTRODUCTION AND AIMS: Despite an increased prevalence of risky alcohol consumption and alcohol-related harm among members of sporting groups and at sporting venues, sporting clubs frequently fail to implement alcohol management practices consistent with liquor legislation and best practice guidelines. The aim of this study was to assess the impact of a multi-strategy intervention in improving the implementation of responsible alcohol management practices by sports clubs. DESIGN AND METHODS: A randomised controlled trial was conducted with 87 football clubs, with half randomised to receive a multi-strategy intervention to support clubs to implement responsible alcohol management practices. The 2-year intervention, which was based on implementation and capacity building theory and frameworks, included project officer support, funding, accreditation rewards, printed resources, observational audit feedback, newsletters, training and support from state sporting organisations. Interviews were undertaken with club presidents at baseline and post-intervention to assess alcohol management practice implementation. RESULTS: Post-intervention, 88% of intervention clubs reported implementing '13 or more' of 16 responsible alcohol management practices, which was significantly greater than the proportion of control groups reporting this level of implementation (65%) [odds ratio: 3.7 (95% confidence interval: 1.1-13.2); P = 0.04]. All intervention components were considered highly useful and three-quarters or more of clubs rated the amount of implementation support to be sufficient. DISCUSSION AND CONCLUSIONS: The multi-strategy intervention was successful in improving alcohol management practices in community sports clubs. Further research is required to better understand implementation barriers and to assess the long-term sustainability of the change in club alcohol management practices.

Multicenter randomized controlled trial of a home walking intervention after outpatient cardiac rehabilitation on health-related quality of life in women

BACKGROUND: Poor health-related quality of life (HRQL) has been shown to be predictive of adverse outcomes in cardiac patients. As women with coronary heart disease have been shown to have lower HRQL than men with coronary heart disease, women are at greater risk of a poor clinical outcome. This study tested the effect of a 12-week home walking intervention after completion of outpatient cardiac rehabilitation (OCR) on HRQL and maintenance of physical activity among women. DESIGN: Multicenter two-group randomized trial. METHODS: After completion of OCR, participants were randomly allocated to the intervention or usual care groups. The outcomes were HRQL (assessed using the MacNew Heart Disease HRQL instrument) and self-reported physical activity (assessed using the Stages of Change model of exercise behavior) at 3, 6, and 12 months after OCR. RESULTS: Seventy-two women were randomized to the intervention and 81 to usual care. Attrition was greater in the treatment group (13 vs. 1%). HRQL scores increased relative to the base level in both arms and were significantly higher in the intervention group at 6 months, but not at 3 or 12 months. Maintenance of physical activity declined over time in both groups, however, this decline was significantly reduced among women in the intervention group. CONCLUSION: HRQL improved in both groups, but seemed to increase earlier among women in the intervention group. As maintenance of physical activity was higher among women in the intervention group, this minimal intervention could be used to facilitate women's progression from supervised to independent exercise.

Randomized controlled trial of proactive web-based alcohol screening and brief intervention for university students

BACKGROUND: University students drink more heavily than their nonstudent peers and are often unaware that their drinking is risky and exceeds normative levels. We tested the efficacy of a proactive Web-based alcohol screening and brief intervention program. METHODS: A randomized controlled trial was conducted at an Australian university in 2007. Invitations were sent to 13 000 undergraduates (age range, 17-24 years) to complete a Web-based Alcohol Use Disorders Identification Test. Of 7237 students who responded, 2435 scored in the hazardous/harmful range (> or =8) and were randomized, and 2050 (84%) completed at least 1 follow-up assessment. Intervention was 10 minutes of Web-based motivational assessment and personalized feedback. Controls received only screening. Follow-up assessments were conducted at 1 and 6 months with observers and participants blinded to allocation. Outcome measures were drinking frequency, typical occasion quantity, overall volume, number of personal problems, an academic problems score, prevalence of binge drinking, and prevalence of heavy drinking. RESULTS: Mean (SD) baseline Alcohol Use Disorders Identification Test scores for control and intervention groups were 14.3 (5.1) and 14.2 (5.1), respectively. After 1 month, participants receiving intervention drank less often (rate ratio [RR], 0.89; 95% confidence interval [CI], 0.83-0.94), smaller quantities per occasion (RR, 0.93; 95% CI, 0.88-0.98), and less alcohol overall (RR, 0.83; 95% CI, 0.78-0.90) than did controls. Differences in alcohol-related harms were nonsignificant. At 6 months, intervention effects persisted for drinking frequency (RR, 0.91; 95% CI, 0.85-0.97) and overall volume (RR, 0.89; 95% CI, 0.82-0.96) but not for other variables. CONCLUSION: Proactive Web-based screening and intervention reduces drinking in undergraduates, and such a program could be implemented widely.

6-PACK programme to decrease fall injuries in acute hospitals: cluster randomised controlled trial

OBJECTIVE:  To evaluate the effect of the 6-PACK programme on falls and fall injuries in acute wards. DESIGN:  Cluster randomised controlled trial. SETTING:  Six Australian hospitals. PARTICIPANTS:  All patients admitted to 24 acute wards during the trial period. INTERVENTIONS:  Participating wards were randomly assigned to receive either the nurse led 6-PACK programme or usual care over 12 months. The 6-PACK programme included a fall risk tool and individualised use of one or more of six interventions: "falls alert" sign, supervision of patients in the bathroom, ensuring patients' walking aids are within reach, a toileting regimen, use of a low-low bed, and use of a bed/chair alarm. MAIN OUTCOME MEASURES:  The co-primary outcomes were falls and fall injuries per 1000 occupied bed days. RESULTS:  During the trial, 46 245 admissions to 16 medical and eight surgical wards occurred. As many people were admitted more than once, this represented 31 411 individual patients. Patients' characteristics and length of stay were similar for intervention and control wards. Use of 6-PACK programme components was higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; P<0.001). In all, 1831 falls and 613 fall injuries occurred, and the rates of falls (incidence rate ratio 1.04, 0.78 to 1.37; P=0.796) and fall injuries (0.96, 0.72 to 1.27; P=0.766) were similar in intervention and control wards. CONCLUSIONS:  Positive changes in falls prevention practice occurred following the introduction of the 6-PACK programme. However, no difference was seen in falls or fall injuries between groups. High quality evidence showing the effectiveness of falls prevention interventions in acute wards remains absent. Novel solutions to the problem of in-hospital falls are urgently needed. TRIAL REGISTRATION:  Australian New Zealand Clinical Trials Registry ACTRN12611000332921.

Building the capacity of family day care educators to promote children’s social and emotional wellbeing: Results of an exploratory cluster randomised-controlled trial

© 2015 Early Childhood Australia Inc. All rights reserved. THIS PAPER PRESENTS THE results of an exploratory cluster randomised-controlled trial that was used to pilot Thrive, a capacity-building program for family day care (FDC) educators. Participants were educators and coordinators from one FDC service in Melbourne, Australia. Data collection consisted of a survey including information on costs, an in-home quality of care observation and process evaluation. Data was collected over 12 months (2011–2012), at baseline and one, six and 12 months post-intervention. Positive caregiver interaction scores increased over time for the intervention group: F (3, 51.69) = 3.08, p < 0.05, and detached interaction scores decreased over time: F (3, 51.19) = 2.78, p < 0.05. Educators’ knowledge and confidence in children’s social and emotional wellbeing showed no significant change. Thrive gives important information about the challenges FDC educators face and is relevant to implementing changes in their education and support. For a program like Thrive to be successful in engaging educators, a stronger framework for supporting additional learning activities at both the FDC organisational and scheme level is warranted.

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial

BACKGROUND: Physical activity is a modifiable behavior related to many preventable non-communicable diseases. There is an age-related decline in physical activity levels in young people, which tracks into adulthood. Common interactive technologies such as smartphones, particularly employing immersive features, may enhance the appeal and delivery of interventions to increase levels of physical activity in young people. The primary aim of the Apps for IMproving FITness (AIMFIT) trial is to evaluate the effectiveness of two popular "off-the-shelf" smartphone apps for improving cardiorespiratory fitness in young people.

METHODS/DESIGN: A three-arm, parallel, randomized controlled trial will be conducted in Auckland, New Zealand. Fifty-one eligible young people aged 14-17 years will be randomized to one of three conditions: 1) use of an immersive smartphone app, 2) use of a non-immersive app, or 3) usual behavior (control). Both smartphone apps consist of an eight-week training program designed to improve fitness and ability to run 5 km, however, the immersive app features a game-themed design and adds a narrative. Data are collected at baseline and 8 weeks. The primary outcome is cardiorespiratory fitness, assessed as time to complete the one mile run/walk test at 8 weeks. Secondary outcomes are physical activity levels, self-efficacy, enjoyment, psychological need satisfaction, and acceptability and usability of the apps. Analysis using intention to treat principles will be performed using regression models.

DISCUSSION: Despite the proliferation of commercially available smartphone applications, there is a dearth of empirical evidence to support their effectiveness on the targeted health behavior. This pragmatic study will determine the effectiveness of two popular "off-the-shelf" apps as a stand-alone instrument for improving fitness and physical activity among young people. Adherence to app use will not be closely controlled; however, random allocation of participants, a heterogeneous group, and data analysis using intention to treat principles provide internal and external validity to the study. The primary outcome will be objectively assessed with a valid and reliable field-based test, as well as the secondary outcome of physical activity, via accelerometry. If effective, such applications could be used alongside existing interventions to promote fitness and physical activity in this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613001030763. Registered 16 September 2013.

A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial

BACKGROUND: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial.

METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline).

DISCUSSION: This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children. If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity.

Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial

BACKGROUND: Gram-negative bacteria such as Escherichia coli or Klebsiella spp. frequently cause bloodstream infections. There has been a worldwide increase in resistance in these species to antibiotics such as third generation cephalosporins, largely driven by the acquisition of extended-spectrum beta-lactamase or plasmid-mediated AmpC enzymes. Carbapenems have been considered the most effective therapy for serious infections caused by such resistant bacteria; however, increased use creates selection pressure for carbapenem resistance, an emerging threat arising predominantly from the dissemination of genes encoding carbapenemases. Recent retrospective data suggest that beta-lactam/beta-lactamase inhibitor combinations, such as piperacillin-tazobactam, may be non-inferior to carbapenems for the treatment of bloodstream infection caused by extended-spectrum beta-lactamase-producers, if susceptible in vitro. This study aims to test this hypothesis in an effort to define carbapenem-sparing alternatives for these infections.

METHODS/DESIGN: The study will use a multicentre randomised controlled open-label non-inferiority trial design comparing two treatments, meropenem (standard arm) and piperacillin-tazobactam (carbapenem-sparing arm) in adult patients with bacteraemia caused by E. coli or Klebsiella spp. demonstrating non-susceptibility to third generation cephalosporins. Recruitment is planned to occur in sites across three countries (Australia, New Zealand and Singapore). A total sample size of 454 patients will be required to achieve 80% power to determine non-inferiority with a margin of 5%. Once randomised, definitive treatment will be for a minimum of 4 days, but up to 14 days with total duration determined by treating clinicians. Data describing demographic information, antibiotic use, co-morbid conditions, illness severity, source of infection and other risk factors will be collected. Vital signs, white cell count, use of vasopressors and days to bacteraemia clearance will be recorded up to day 7. The primary outcome measure will be mortality at 30 days, with secondary outcomes including days to clinical and microbiological resolution, microbiological failure or relapse, isolation of a multi-resistant organism or Clostridium difficile infection.

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program : a cluster-randomized controlled trial of an early intervention to prevent childhood obesity

BACKGROUND: Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. METHODS/DESIGN: The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. DISCUSSION: This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. TRIAL REGISTRATION: ACTRN12611000386932 . Registered 13 April 2011.

A process evaluation of the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial

BACKGROUND: Supermarket Healthy Eating for Life (SHELf) was a randomized controlled trial that operationalized a socioecological approach to population-level dietary behaviour change in a real-world supermarket setting. SHELf tested the impact of individual (skill-building), environmental (20 % price reductions), and combined (skill-building + 20 % price reductions) interventions on women's purchasing and consumption of fruits, vegetables, low-calorie carbonated beverages and water. This process evaluation investigated the reach, effectiveness, implementation, and maintenance of the SHELf interventions.

METHODS: RE-AIM provided a conceptual framework to examine the processes underlying the impact of the interventions using data from participant surveys and objective sales data collected at baseline, post-intervention (3 months) and 6-months post-intervention. Fisher's exact, χ (2) and t-tests assessed differences in quantitative survey responses among groups. Adjusted linear regression examined the impact of self-reported intervention dose on food purchasing and consumption outcomes. Thematic analysis identified key themes within qualitative survey responses.

RESULTS: Reach of the SHELf interventions to disadvantaged groups, and beyond study participants themselves, was moderate. Just over one-third of intervention participants indicated that the interventions were effective in changing the way they bought, cooked or consumed food (p < 0.001 compared to control), with no differences among intervention groups. Improvements in purchasing and consumption outcomes were greatest among those who received a higher intervention dose. Most notably, participants who said they accessed price reductions on fruits and vegetables purchased (519 g/week) and consumed (0.5 servings/day) more vegetables. The majority of participants said they accessed (82 %) and appreciated discounts on fruits and vegetables, while there was limited use (40 %) and appreciation of discounts on low-calorie carbonated beverages and water. Overall reported satisfaction with, use, and impact of the skill-building resources was moderate. Maintenance of newly acquired behaviours was limited, with less than half of participants making changes or using study-provided resources during the 6-month post-intervention period.

CONCLUSIONS: SHELf's reach and perceived effectiveness were moderate. The interventions were more effective among those reporting greater engagement with them (an implementation-related construct). Maintenance of newly acquired behaviours proved challenging.

Affective instability and the course of bipolar depression: results from the STEP-BD randomised controlled trial of psychosocial treatment

BACKGROUND: Little is known about predictors of recovery from bipolar depression. AIMS: We investigated affective instability (a pattern of frequent and large mood shifts over time) as a predictor of recovery from episodes of bipolar depression and as a moderator of response to psychosocial treatment for acute depression. METHOD: A total of 252 out-patients with DSM-IV bipolar I or II disorder and who were depressed enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) and were randomised to one of three types of intensive psychotherapy for depression (n = 141) or a brief psychoeducational intervention (n = 111). All analyses were by intention-to-treat. RESULTS: Degree of instability of symptoms of depression and mania predicted a lower likelihood of recovery and longer time until recovery, independent of the concurrent effects of symptom severity. Affective instability did not moderate the effects of psychosocial treatment on recovery from depression. CONCLUSIONS: Affective instability may be a clinically relevant characteristic that influences the course of bipolar depression.