Outcomes of a randomised controlled trial of the application of cognitive and behaviour therapies for problematic gambling : implications for the Statewide Gambling Therapy Service treatment model

Through an ongoing research programme, the Statewide Gambling Therapy Service (SGTS) in South Australia has been systematically developing approaches to treatment and relapse prevention in order to include a wider range of clients in the treatment programme, help them recover from their gambling problems and support them to avoid relapse to problematic gambling post treatment.In a recent randomised controlled trial exploring the efficacy of cognitive versus behavioural therapy in the treatment of problematic gambling disorders in SGTS, no significant differences were found between clinical outcomes of the two treatment modalities. Both purely cognitive and purely bahavioural approaches to therapy had similar outcomes in terms of improvements in measures of health and wellbeing (Work and Social Adjustment Scale: WSAS), general depressioni (Kessler 10: K10) and problematic gambling (Victorian Gambling Screen: VGS). Further studies are planned to test more precisely whether both approaches are indeed equivalent in terms of outcomes achieved for clients. In the mean time, the fact that behavioural therapy (BT) tends to required less treatment sessions to achieve the same outcomes as cognitive therapy (CT) suggests that working to retaining clients in treatment using BT may be a more effective and parsimonious treatment option for people with gambling disorders . This current paper provides an overview of SGTS client engagement and management strategies following the completion of our recent RCT.

Exercise to enhance smoking cessation: the getting physical on cigarette randomized control trial

BACKGROUND: Exercise has been proposed as a useful smoking cessation aid. PURPOSE: The purpose of the present study is to determine the effect of an exercise-aided smoking cessation intervention program, with built-in maintenance components, on post-intervention 14-, 26- and 56-week cessation rates. METHOD: Female cigarette smokers (n = 413) participating in a supervised exercise and nicotine replacement therapy (NRT) smoking cessation program were randomized to one of four conditions: exercise + smoking cessation maintenance, exercise maintenance + contact control, smoking cessation maintenance + contact control or contact control. The primary outcome was continuous smoking abstinence. RESULTS: Abstinence differences were found between the exercise and equal contact non-exercise maintenance groups at weeks 14 (57 vs 43 %), 26 (27 vs 21 %) and 56 (26 vs 23.5 %), respectively. Only the week 14 difference approached significance, p = 0.08. CONCLUSIONS: An exercise-aided NRT smoking cessation program with built-in maintenance components enhances post-intervention cessation rates at week 14 but not at weeks 26 and 56.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Background Early mobilisation after stroke is thought to contribute to the eff ects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.MethodsWe did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteriawere randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.FindingsBetween July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.InterpretationFirst mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refi ning present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.

VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited.

Continuity of care by a primary midwife (caseload midwifery) increases women's satisfaction with antenatal, intrapartum and postpartum care: results from the COSMOS randomised controlled trial

BACKGROUND: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.

METHODS: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.

RESULTS: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).

CONCLUSION: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.

The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial

BACKGROUND: Some degree of cognitive decline after surgery occurs in as many as one quarter of elderly surgical patients, and this decline is associated with increased morbidity and mortality. Cognition may be affected across a range of domains, including memory, psychomotor skills, and executive function. Whilst the exact mechanisms of cognitive change after surgery are not precisely known, oxidative stress and subsequent neuroinflammation have been implicated. N-acetylcysteine (NAC) acts via multiple interrelated mechanisms to influence oxidative homeostasis, neuronal transmission, and inflammation. NAC has been shown to reduce oxidative stress and inflammation in both human and animal models. There is clinical evidence to suggest that NAC may be beneficial in preventing the cognitive decline associated with both acute physiological insults and dementia-related disorders. To date, no trials have examined perioperative NAC as a potential moderator of postoperative cognitive changes in the noncardiac surgery setting.

METHODS AND DESIGN: This is a single-centre, randomised, double-blind, placebo-controlled clinical trial, with a between-group, repeated-measures, longitudinal design. The study will recruit 370 noncardiac surgical patients at the University Hospital Geelong, aged 60 years or older. Participants are randomly assigned to receive either NAC or placebo (1:1 ratio), and groups are stratified by age and surgery type. Participants undergo a series of neuropsychological tests prior to surgery, 7 days, 3 months, and 12 months post surgery. It is hypothesised that the perioperative administration of NAC will reduce the degree of postoperative cognitive changes at early and long-term follow-up, as measured by changes on individual measures of the neurocognitive battery, when compared with placebo. Serum samples are taken on the day of surgery and on day 2 post surgery to quantitate any changes in levels of biomarkers of inflammation and oxidative stress.

DISCUSSION: The PANACEA trial aims to examine the potential efficacy of perioperative NAC to reduce the severity of postoperative cognitive dysfunction in an elderly, noncardiac surgery population. This is an entirely novel approach to the prevention of postoperative cognitive dysfunction and will have high impact and translatable outcomes if NAC is found to be beneficial.

Assessing the sustained impact of a school-based obesity prevention program for adolescent boys: the ATLAS cluster randomized controlled trial

BACKGROUND: Obesity prevention interventions targeting 'at-risk' adolescents are urgently needed. The aim of this study is to evaluate the sustained impact of the 'Active Teen Leaders Avoiding Screen-time' (ATLAS) obesity prevention program.

METHODS: Cluster RCT in 14 secondary schools in low-income communities of New South Wales, Australia. Participants were 361 adolescent boys (aged 12-14 years) 'at risk' of obesity. The intervention was based on Self-Determination Theory and Social Cognitive Theory and involved: professional development, fitness equipment for schools, teacher-delivered physical activity sessions, lunch-time activity sessions, researcher-led seminars, a smartphone application, and parental strategies. Assessments for the primary (body mass index [BMI], waist circumference) and secondary outcomes were conducted at baseline, 8- (post-intervention) and 18-months (follow-up). Analyses followed the intention-to-treat principle using linear mixed models.

RESULTS: After 18-months, there were no intervention effects for BMI or waist circumference. Sustained effects were found for screen-time, resistance training skill competency, and motivational regulations for school sport.

CONCLUSIONS: There were no clinically meaningful intervention effects for the adiposity outcomes. However, the intervention resulted in sustained effects for secondary outcomes. Interventions that more intensively target the home environment, as well as other socio-ecological determinants of obesity may be needed to prevent unhealthy weight gain in adolescents from low-income communities.

Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH): process evaluation of a randomised controlled trial intervention.

BACKGROUND: The Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH) trial tested a family intervention to reduce screen-based sedentary behaviour in overweight children. The trial found no significant effect of the intervention on children's screen-based sedentary behaviour. To explore these null findings, we conducted a pre-planned process evaluation, focussing on intervention delivery and uptake. METHODS: SWITCH was a randomised controlled trial of a 6-month family intervention to reduce screen time in overweight children aged 9-12 years (n = 251). Community workers met with each child's primary caregiver to deliver the intervention content. Community workers underwent standard training and were monitored once by a member of the research team to assess intervention delivery. The primary caregiver implemented the intervention with their child, and self-reported intervention use at 3 and 6 months. An exploratory analysis determined whether child outcomes at 6 months varied by primary caregiver use of the intervention. RESULTS: Monitoring indicated that community workers delivered all core intervention components to primary caregivers. However, two thirds of primary caregivers reported using any intervention component "sometimes" or less frequently at both time points, suggesting that intervention uptake was poor. Additionally, analyses indicated no effect of primary caregiver intervention use on child outcomes at 6 months, suggesting the intervention itself lacked efficacy. CONCLUSIONS: Poor uptake, and the efficacy of the intervention itself, may have played a role in the null findings of the SWITCH trial on health behaviour and body composition. TRIAL REGISTRATION: The trial was registered in the Australian and New Zealand Clinical Trials Registry (no. ACTRN12611000164998 ); registration date: 10/02/2011.

Cognitive-behavioural therapy for inflammatory bowel disease: 24-month data from a randomised controlled trial

PURPOSE: There is ongoing controversy on the effectiveness of psychotherapy in inflammatory bowel disease (IBD). In the few small studies, cognitive-behavioural therapy (CBT) has been shown to alleviate symptoms of anxiety or depression. However, there is little research on the impact of CBT on physical outcomes in IBD and no studies on long-term effectiveness of CBT.

METHODS: The present two-arm pragmatic randomised controlled trial aimed to establish the impact of CBT on disease course after 24 months of observation. The study compared standard care plus CBT (+CBT) with standard care alone (SC). CBT was delivered over 10 weeks, face-to-face (F2F) or online (cCBT). The data were analysed using linear mixed-effects models.

RESULTS: CBT did not significantly influence disease activity as measured by disease activity indices at 24 months (Crohn's Disease Activity Index (CDAI), p = 0.92; Simple Clinical Colitis Activity Index (SCCAI), p = 0.88) or blood parameters (C-reactive protein (CRP), p < 0.62; haemoglobin (Hb), p = 0.77; platelet, p = 0.64; white cell count (WCC), p = 0.59) nor did CBT significantly affect mental health, coping or quality of life (all p > 0.05).

CONCLUSIONS: Therefore, we conclude that CBT does not influence the course of IBD over 24 months. Given the high rate of attrition, particularly in the CBT group, future trials should consider a personalised approach to psychotherapy, perhaps combining online and one-to-one therapist time.

Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial.

BACKGROUND: Studies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone. METHODS: A 2-arm parallel pragmatic randomised controlled trial (+CBT - standard care plus either face-to-face (F2F) or online CBT over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline. RESULTS: Participants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p >0.05). When only participants classified as 'in need' (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n = 74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p = .034, d = .56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p = .045). CONCLUSIONS: Future studies should direct psychological interventions to patients 'in need' and attempt to recruit larger samples to compensate for significant attrition when using online CBT. TRIAL REGISTRATION: The protocol was registered on 21/10/2009 with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12609000913279).

Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol

BACKGROUND: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery.

METHODS/DESIGN: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined.

DISCUSSION: This protocol describes a novel intervention which tests new therapeutic methods including in-session tablet computer use and video-based peer modelling. It also informs a possible low intensity intervention model potentially viable for delivery across the mental health workforce.

Addressing the potential adverse effects of school-based BMI assessments on children

Introduction. Do child obesity prevention research and intervention measures have the potential to generate adverse concerns about body image by focussing on food, physical activity and body weight? Research findings now demonstrate the emergence of body image concerns in children as young as 5 years. In the context of a large school-community-based child health promotion and obesity prevention study, we aimed to address the potential negative effects of height and weight measures on child wellbeing by developing and implementing an evidence-informed protocol to protect and prevent body image concerns. fun 'n healthy in Moreland! is a cluster randomised controlled trial of a child health promotion and obesity prevention intervention in 23 primary schools in an inner urban area of Melbourne, Australia. Body image considerations were incorporated into the study philosophies, aims, methods, staff training, language, data collection and reporting procedures of this study. This was informed by the published literature, professional body image expertise, pilot testing and implementation in the conduct of baseline data collection and the intervention. This study is the first record of a body image protection protocol being an integral part of the research processes of a child obesity prevention study. Whilst we are yet to measure its impact and outcome, we have developed and tested a protocol based on the evidence and with support from stakeholders in order to minimise the adverse impact of study processes on child body image concerns.

Cost-effectiveness of physical activity counselling in general practice

AIM: To assess the cost-effectiveness of the 'Green Prescription' physical activity counselling programme in general practice.
METHOD: Prospective cost-effectiveness study undertaken as part of a cluster randomised controlled trial with 12-month follow-up of 878 'less-active' patients aged 40-79 years in 42 general practices in the Waikato. The intervention was verbal advice and a written exercise prescription given by general practitioners, with telephone exercise specialist follow-up compared with usual care. Main outcome measures included cost per total and leisure-time physical activity gain from health-funders' and societal perspectives.
RESULTS: Significant increases in physical activity were found in the randomised controlled trial. Programme-cost per patient was NZ170 dollars from a funder's perspective. The monthly cost-effectiveness ratio for total energy expenditure achieved was 11 dollars per kcal/kg/day. The incremental cost of converting one additional 'sedentary' adult to an 'active' state over a twelve-month period was NZ1,756 dollars in programme costs.
CONCLUSION: Verbal and written physical activity advice given in general practice with telephone follow-up is an inexpensive way of increasing activity for sedentary people, and has the potential to have significant economic impact through reduction in cardiovascular and other morbidity and mortality.