Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

<p>Abstract</p> <p>Background</p> <p>The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD). The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders.</p> <p>Methods/Design</p> <p>250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia), Body Mass Index (BMI) category (normal, overweight, obese) and type of antipsychotic medication (typical, atypical). Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour) or by telephone (typically 10 minutes). Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months.</p> <p>Discussion</p> <p>This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals.</p> <p>Trial registration</p> <p>Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: <a href="http://www.anzctr.org.au/ACTRN12609001039279.aspx">ACTRN12609001039279</a></p

Treatment and outcomes of an Australian cohort of outpatients with bipolar 1 or schizoaffective disorder over twenty-four months : implications for clinical practice

Background The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with &lsquo;real-world&rsquo; treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication.Methods Participants prescribed either conventional mood stabilizers (CMS; n&thinsp;=&thinsp;155) alone, or olanzapine with, or without, CMS (olanzapine&thinsp;&plusmn;&thinsp;CMS; n&thinsp;=&thinsp;84) were assessed every 3&thinsp;months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale &ndash; Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data.Results On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24&thinsp;months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine&thinsp;&plusmn;&thinsp;CMS (61%;) cohorts.Conclusions Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome.<br /

“Quitlink”—A Randomized Controlled Trial of Peer Worker Facilitated Quitline Support for Smokers Receiving Mental Health Services: Study Protocol

Introduction: Although smokers with severe mental illnesses (SSMI) make quit attempts at comparable levels to other smokers, fewer are successful in achieving smoking cessation. Specialized smoking cessation treatments targeting their needs can be effective but have not been widely disseminated. Telephone delivered interventions, including by quitlines, show promise. However, few SSMI contact quitlines and few are referred to them by health professionals. Mental health peer workers can potentially play an important role in supporting smoking cessation. This study will apply a pragmatic model using peer workers to engage SSMI with a customized quitline service, forming the “Quitlink” intervention.Methods: A multi-center prospective, cluster-randomized, open, blinded endpoint (PROBE) trial. Over 3 years, 382 smokers will be recruited from mental health services in Victoria, Australia. Following completion of baseline assessment, a brief intervention will be delivered by a peer worker. Participants will then be randomly allocated either to no further intervention, or to be referred and contacted by the Victorian Quitline and offered a targeted 8-week cognitive behavioral intervention along with nicotine replacement therapy (NRT). Follow-up measures will be administered at 2-, 5-, and 8-months post-baseline. The primary outcome is 6 months continuous abstinence from end of treatment with biochemical verification. Secondary outcomes include 7-day point prevalence abstinence from smoking, increased quit attempts, and reductions in cigarettes per day, cravings and withdrawal, mental health symptoms, and other substance use, and improvements in quality of life. We will use a generalized linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle clustering and the repeated measures at baseline, 2-, 5-, and 8-months; individuals will be modeled as random effects, cluster as a random effect, and group assignment as a fixed effect.Discussion: This is the first rigorously designed RCT to evaluate a specialized quitline intervention accompanied by NRT among SSMI. The study will apply a pragmatic model to link SSMI to the Quitline, using peer workers, with the potential for wide dissemination.Clinical Trial Registration:Trial Registry: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines.Trial Sponsor: University of Newcastle, NSW, Australia

Sequential behavioral treatment of smoking and weight control in biploar disorder

People with severe mental illnesses like schizophrenia and bipolar disorder (BPAD) live significantly shorter lives than people in the general population and most commonly die of cardiovascular disease (CVD). CVD risk behaviors such as smoking are not routinely assessed or assertively treated among people with a severe mental illness. This article provides an illustrative case example of a woman with BPAD who is motivated to quit smoking, despite concerns about weight gain and relapse to depression. It outlines key considerations and describes the patient’s experience of participating in a behavioral intervention focussing first on smoking, then diet and physical activity. Clinical challenges encountered during treatment are discussed in the context of relevant literature. These include motivational issues, relapse to depression, medication interactions, weight gain, addressing multiple health behavior change, focussing on a behavioral rather than cognitive approach, collaborating with other health care providers, and gender issues

The impact of age at onset of bipolar I disorder on functioning and clinical presentation outcomes after 12 months

Abstract not available

The perceived risks and benefits of quitting in smokers diagnosed with severe mental illness participating in a smoking cessation intervention: gender differences and comparison to smokers without mental illness

INTRODUCTION AND AIMS: This study aimed to examine the perceived risks and benefits of quitting in smokers diagnosed with psychosis, including potential gender differences and comparisons to smokers in the general population. DESIGN AND METHODS: Data were collected from 200 people diagnosed with psychosis participating in a randomised controlled trial testing the effectiveness of a multi-component intervention for smoking cessation and cardiovascular disease risk reduction in people with severe mental illness. Results were compared with both treatment and non-treatment seeking smokers in the general population. RESULTS: Male and female smokers with psychosis generally had similar perceived risks and benefits of quitting. Females rated it significantly more likely that they would experience weight gain and negative affect upon quitting than males diagnosed with psychosis. Compared with smokers in the general population also seeking smoking cessation treatment, this sample of smokers with psychosis demonstrated fewer gender differences and lower ratings of perceived risks and benefits of quitting. The pattern of risk and benefit ratings in smokers diagnosed with psychosis was similar to those of non-treatment seeking smokers in the general population. DISCUSSION AND CONCLUSIONS: These results increase our understanding of smoking in people with severe mental illness, and can directly inform smoking interventions to maximise successful abstinence for this group of smokers. For female smokers with psychosis, smoking cessation interventions need to address concerns regarding weight gain and negative affect. Intervention strategies aimed at enhancing beliefs about the benefits of quitting smoking for both male and female smokers with psychosis are necessary