'Quitlink': Outcomes of a randomised controlled trial of peer researcher facilitated referral to a tailored quitline tobacco treatment for people receiving mental health services.

OBJECTIVE: The aim of this study was to test the effectiveness of a tailored quitline tobacco treatment ('Quitlink') among people receiving support for mental health conditions. METHODS: We employed a prospective, cluster-randomised, open, blinded endpoint design to compare a control condition to our 'Quitlink' intervention. Both conditions received a brief intervention delivered by a peer researcher. Control participants received no further intervention. Quitlink participants were referred to a tailored 8-week quitline intervention delivered by dedicated Quitline counsellors plus combination nicotine replacement therapy. The primary outcome was self-reported 6 months continuous abstinence from end of treatment (8 months from baseline). Secondary outcomes included additional smoking outcomes, mental health symptoms, substance use and quality of life. A within-trial economic evaluation was conducted. RESULTS: In total, 110 participants were recruited over 26 months and 91 had confirmed outcomes at 8 months post baseline. There was a difference in self-reported prolonged abstinence at 8-month follow-up between Quitlink (16%, n = 6) and control (2%, n = 1) conditions, which was not statistically significant (OR = 8.33 [0.52, 132.09] p = 0.131 available case). There was a significant difference in favour of the Quitlink condition on 7-day point prevalence at 2 months (OR = 8.06 [1.27, 51.00] p = 0.027 available case). Quitlink costs AU$9231 per additional quit achieved. CONCLUSION: The Quitlink intervention did not result in significantly higher rates of prolonged abstinence at 8 months post baseline. However, engagement rates and satisfaction with the 'Quitlink' intervention were high. While underpowered, the Quitlink intervention shows promise. A powered trial to determine its effectiveness for improving long-term cessation is warranted.

The value of compassionate support to address smoking: A qualitative study with people who experience severe mental illness.

Introduction: People experiencing severe mental illness (SMI) smoke at much higher rates than the general population and require additional support. Engagement with existing evidence-based interventions such as quitlines and nicotine replacement therapy (NRT) may be improved by mental health peer worker involvement and tailored support. This paper reports on a qualitative study nested within a peer researcher-facilitated tobacco treatment trial that included brief advice plus, for those in the intervention group, tailored quitline callback counseling and combination NRT. It contextualizes participant life experience and reflection on trial participation and offers insights for future interventions. Methods: Qualitative semi-structured interviews were conducted with 29 participants in a randomized controlled trial (intervention group n = 15, control group n = 14) following their 2-month (post-recruitment) follow-up assessments, which marked the end of the "Quitlink" intervention for those in the intervention group. Interviews explored the experience of getting help to address smoking (before and during the trial), perceptions of main trial components including assistance from peer researchers and tailored quitline counseling, the role of NRT, and other support received. A general inductive approach to analysis was applied. Results: We identified four main themes: (1) the long and complex journey of quitting smoking in the context of disrupted lives; (2) factors affecting quitting (desire to quit, psychological and social barriers, and facilitators and reasons for quitting); (3) the perceived benefits of a tailored approach for people with mental ill-health including the invitation to quit and practical resources; and (4) the importance of compassionate delivery of support, beginning with the peer researchers and extended by quitline counselors for intervention participants. Subthemes were identified within each of these overarching main themes. Discussion: The findings underscore the enormity of the challenges that our targeted population face and the considerations needed for providing tobacco treatment to people who experience SMI. The data suggest that a tailored tobacco treatment intervention has the potential to assist people on a journey to quitting, and that compassionate support encapsulating a recovery-oriented approach is highly valued. Clinical trial registration: The Quitlink trial was registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines.

"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.

Randomised controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders: Outcomes to 36 months.

OBJECTIVE: People living with psychotic disorders (schizophrenia spectrum and bipolar disorders) have high rates of cardiovascular disease risk behaviours, including smoking, physical inactivity and poor diet. We report cardiovascular disease risk, smoking cessation and other risk behaviour outcomes over 36 months following recruitment into a two-arm randomised controlled trial among smokers with psychotic disorders. METHODS: Participants ( N = 235) drawn from three sites were randomised to receive nicotine replacement therapy plus (1) a Healthy Lifestyles intervention delivered over approximately 9 months or (2) a largely telephone-delivered intervention (designed to control for nicotine replacement therapy provision, session frequency and other monitoring). The primary outcome variables were 10-year cardiovascular disease risk and smoking status, while the secondary outcomes included weekly physical activity, unhealthy eating, waist circumference, psychiatric symptomatology, depression and global functioning. RESULTS: Significant reductions in cardiovascular disease risk and smoking were detected across the 36-month follow-up period in both intervention conditions, with no significant differences between conditions. One-quarter (25.5%) of participants reported reducing cigarettes per day by 50% or more at multiple post-treatment assessments; however, few (8.9%) managed to sustain this across the majority of time points. Changes in other health behaviours or lifestyle factors were modest; however, significant improvements in depression and global functioning were detected over time in both conditions. Participants experiencing worse 'social discomfort' at baseline (e.g. anxiety, mania, poor self-esteem and social disability) had on average significantly worse global functioning, lower scores on the 12-Item Short Form Health Survey physical scale and significantly greater waist circumference. CONCLUSION: Although the telephone-delivered intervention was designed as a comparison condition, it achieved excellent retention and comparable outcomes. Telephone-delivered smoking cessation support may potentially help to reduce smoking rates among people with psychotic disorders. Discomfort in social situations may also be a useful target for future health interventions, addressing confidence and social skills, and promoting social networks that reduce inactivity.

Self-Reported Reasons for Smoking: Predicting Abstinence and Implications for Smoking Cessation Treatments Among Those With a Psychotic Disorder.

OBJECTIVES: People living with a psychotic illness have higher rates of cigarette smoking and face unique barriers to quitting compared to the general population. We examined whether self-reported reasons for smoking are useful predictors of successful quit attempts among people with psychosis. METHODS: As part of a randomized controlled trial addressing smoking and cardiovascular disease risk behaviors among people with psychosis, self-reported reasons for smoking were assessed at baseline (n = 235), 15 weeks (n = 151), and 12 months (n = 139). Three factors from the Reasons for Smoking Questionnaire (Coping, Physiological, and Stimulation/Activation) were entered into a model to predict short- and long-term abstinence. The relationship between these factors and mental health symptoms were also assessed. RESULTS: Participants scoring higher on the Stimulation/Activation factor (control of weight, enjoyment, concentration, and "peps me up") at baseline were just less than half as likely to be abstinent at 15 weeks. Female participants were five times more likely to abstinent at 15 weeks, and those with a higher global functioning at baseline were 5% more likely to be abstinent. There was a positive correlation between changes over time in the Stimulation/Activation factor from baseline to 12-month follow-up and the Brief Psychiatric Rating Scale total score at 12-month follow-up. This indicates that increasingly higher endorsement of the factor was associated with more psychological symptoms. There was also a negative correlation between the change over time in the Stimulation/Activation factor and global functioning at 12 months, indicating that increasingly higher endorsement of the factor led to lower global assessment of functioning. CONCLUSIONS: The Stimulation/Activation factor may be particularly important to assess and address among smokers with psychosis. It is recommended that further research use the Reasons for Smoking Questionnaire among smokers with psychosis as a clinical tool to identify specific quit barriers. Further research into why females have higher smoking cessation rates in the short term and relapse prevention interventions seem worthy of further investigation.

Early Therapeutic Alliance, Treatment Retention, and 12-Month Outcomes in a Healthy Lifestyles Intervention for People with Psychotic Disorders.

Engaging and retaining individuals with psychotic disorders in psychosocial treatments is difficult. Early therapeutic alliance, treatment retention, and 12-month outcomes were examined in a subsample of smokers with a psychotic disorder (N = 178) participating in a healthy lifestyles study comparing a telephone versus face-to-face delivered intervention. Therapeutic alliance was assessed using the Agnew Relationship Measure; primary outcomes were treatment retention and changes in symptoms and health behaviors. Contrary to expectations, early alliance did not predict treatment retention. However, elements of both client- and therapist-rated alliance predicted some clinical outcomes (e.g., higher confidence in the therapeutic alliance at session 1 predicted improvements in 12-month depression). Some modest interactions between early alliance and intervention condition were also identified (e.g., clients initially with lower self-perceived initiative, or higher therapist-perceived bonding benefited preferentially from the telephone-delivered intervention), highlighting the need to further examine the interplay between therapeutic alliance and treatment modality.

Reducing smoking reduces suicidality among individuals with psychosis: Complementary outcomes from a Healthy Lifestyles intervention study.

This study sought to explore the impact of smoking reduction on suicidality (suicide ideation and behaviour) among people with a psychotic disorder (n=235) who participated in a randomized trial of a healthy lifestyle intervention trial. Suicidality, measured by item -4 of the Brief Psychiatric Rating Scale (BPRS) was the main variable of interest. Measures were collected by research assistants blind to treatment allocation at baseline, at 15 weeks (mid-intervention) and 12 months after baseline. Mediation analysis, adjusted for confounders, was used to determine the relationship between smoking reduction and suicidality and to explore whether this was mediated through depression. At 12 months, smoking reduction was found to be significantly associated with suicidality change; an association was also seen between smoking reduction and depression and depression and suicidality. After adjusting for depression, the association between smoking reduction and suicidality was attenuated but remained statistically significant; the proportion of the total effect that was mediated through depression was 30%. There was no significant association between suicidality and treatment group (vs. controls) over time. Our study suggests that smoking interventions may have benefits over and above those for improved physical health, by reducing suicidal ideation in people with psychosis.

Inpatient views and experiences before and after implementing a totally smoke-free policy in the acute psychiatry hospital setting.

In the present study, we examined the views and experiences of patients admitted to an acute psychiatry unit before and after the implementation of a totally smoke-free policy. Forty-six inpatients completed a questionnaire assessing their views before the smoking ban. Another 52 inpatients completed a questionnaire assessing their views and experiences after the smoking ban. Before the totally smoke-free policy, 69.6% smoked, with 67.7% smoking more when admitted to the psychiatry ward. Before the smoking ban, 54.4% reported that the totally smoke-free policy would be 'negative' or 'very negative,' and 30.5% said it would be 'positive' or 'very positive.' After the totally smoke-free policy, 57.7% smoked heavily before hospital (mean cigarettes/day = 24.9), with consumption dramatically reducing following admission to a totally smoke-free psychiatric unit (mean cigarettes/day = 8.3). After the totally smoke-free policy, 36.5% reported that it was 'negative' or 'very negative,' and 50% reported that it was 'positive' or 'very positive.' Overall, inpatients reported improved acceptance of the policy following implementation. Inpatients stated that the most difficult thing about the smoking ban was experiencing increased negative emotions, while the most positive aspect was the improved physical environment of the ward. Inpatients who smoke must be appropriately supported using a range of strategies, and in the present study, we suggest relevant clinical implications.

Randomized Controlled Trial of a Healthy Lifestyle Intervention Among Smokers With Psychotic Disorders.

INTRODUCTION: People with severe mental disorders typically experience a range of health problems; consequently, interventions addressing multiple health behaviors may provide an efficient way to tackle this major public health issue. This two-arm randomized controlled trial among people with psychotic disorders examined the efficacy of nicotine replacement therapy (NRT) plus either a face-to-face or predominantly telephone delivered intervention for smoking cessation and cardiovascular disease (CVD) risk reduction. METHODS: Following baseline assessment and completion of a common, individually delivered 90-minute face-to-face intervention, participants (n = 235) were randomized to receive NRT plus: (1) a "Healthy Lifestyles" intervention for smoking cessation and CVD risk behaviors or (2) a predominantly telephone-based intervention (designed to control for NRT provision, session frequency, and other monitoring activities). Research assistants blind to treatment allocation performed assessments at 15 weeks (mid-intervention) and 12 months after baseline. RESULTS: There were no significant differences between intervention conditions in CVD risk or smoking outcomes at 15 weeks or 12 months, with improvements in both conditions (eg, 12 months: 6.4% confirmed point prevalence abstinence rate; 17% experiencing a 50% or greater smoking reduction; mean reduction of 8.6 cigarettes per day; mean improvement in functioning of 9.8 points). CONCLUSIONS: The health disparity experienced by people with psychotic disorders is high. Face-to-face Healthy Lifestyle interventions appear to be feasible and somewhat effective. However, given the accessibility of telephone delivered interventions, potentially combined with lower cost, further studies are needed to evaluate telephone delivered smoking cessation and lifestyle interventions for people with psychotic disorders.

Gender differences in characteristics and outcomes of smokers diagnosed with psychosis participating in a smoking cessation intervention.

While research has identified gender differences in characteristics and outcomes of smokers in the general population, no studies have examined this among smokers with psychosis. This study aimed to explore gender differences among 298 smokers with psychosis (schizophrenia, schizoaffective and bipolar affective disorder) participating in a smoking intervention study. Results revealed a general lack of gender differences on a range of variables for smokers with psychosis including reasons for smoking/quitting, readiness and motivation to quit, use of nicotine replacement therapy, and smoking outcomes including point prevalence or continuous abstinence, and there were no significant predictors of smoking reduction status according to gender at any of the follow-up time-points. The current study did find that female smokers with psychosis were significantly more likely than males to report that they smoked to prevent weight gain. Furthermore, the females reported significantly more reasons for quitting smoking and were more likely to be driven by extrinsic motivators to quit such as immediate reinforcement and social influence, compared to the male smokers with psychosis. Clinical implications include specifically focussing on weight issues and enhancing intrinsic motivation to quit smoking for female smokers with psychosis; and strengthening reasons for quitting among males with psychosis.

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.

Demonstrating the effectiveness of less restrictive care pathways for the management of patients treated with clozapine.

OBJECTIVE: The purpose of this study was to measure the effectiveness of two alternative care pathways for managing patients treated with clozapine. METHOD: Medical records for 90 clozapine patients managed via three care pathways were audited for a 24 month period (30 per group). The three care pathways established to manage patients prescribed clozapine include: (1) remaining in public mental health service case management; (2) transitioning to general practitioner-mental health service shared care; or (3) transitioning to private psychiatry sole care. Demographic, illness, medication compliance, service utilisation and performance on clinical outcome measures were collected in the 12 months prior to and following transition. RESULTS: Across both the private psychiatry and general practitioner (GP) shared care transitioned groups, only one patient had a psychiatric hospital admission in the 12 months following transition, and transitioned patients also had fewer mental health service clinician contacts. Good medication compliance, better skills of daily living, lower levels of illicit substance abuse and a lower intensity of case management history were seen in transitioned patients. CONCLUSIONS: Transitioning appropriate patients taking clozapine to less intensive care pathways like private psychiatrists and GP shared care can be effectively achieved if appropriate supports are in place for both the clinicians and their patients.

The sick role, illness cognitions and outcomes in bipolar disorder.

OBJECTIVE: In some individuals, recovery from episodes of mental illness may be impeded by maladaptive illness beliefs and behaviors. For individuals with chronic illness, acceptance of its presence and consequences is necessary to seek appropriate treatment, adjust their lifestyle, and adhere to recommended management strategies. Some have difficulty adjusting out of the sick role or develop a degree of illness investment. The Illness Cognitions Scale (ICS) is a 17-item validated scale that measures cognitive factors associated with the sick role. We conducted analyses to test the hypothesis that there may be an association between illness cognitions and clinical and functional measures. METHODS: The ICS was administered to 89 participants at the final study visit of a 24-month observational study involving patients with bipolar I disorder or schizoaffective disorder. RESULTS: Higher scores on the ICS were correlated with more severe depression (p<0.0001), worse general health (p=0.0002), worse functioning (p=0.0001), and worse scores in psychosocial measures including the State Hope Scale (p=0.0082), the Social Provisions Scale (p=0.0054) and the Rosenberg Self-Esteem Scale (p=0.0025). CONCLUSIONS: Illness cognitions and behavior may be a neglected factor that could influence treatment outcomes in bipolar disorder. The ICS might be useful for identifying individuals whose recovery may be facilitated by targeted psychological intervention that addresses these factors.

Treatment and outcomes of an Australian cohort of outpatients with bipolar I 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 'real-world' 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 = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale - 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 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 ± 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.

Varenicline plus healthy lifestyle intervention for smoking cessation in psychotic disorders.

BACKGROUND: We were interested in exploring the efficacy and safety of varenicline as an adjunct to a healthy lifestyle intervention for smoking cessation among individuals with a severe mental illness. METHODS: We used varenicline as an adjunct to a healthy lifestyle intervention in 14 smokers with a psychotic illness. RESULTS: Overall, smoking cessation rates were 36% at 3 months and 42% at 6 months. The most commonly reported side effects were sleep disturbance and nausea. These tended to occur early in treatment, and patients responded to general measures of support and reassurance. Of the 14 participants, 1 dropped out because of psychiatric problems and 2 because of other side effects. CONCLUSIONS: Varenicline appears to be an effective adjunct to a healthy lifestyle intervention for smokers with a psychotic illness. Although the results of this open study are encouraging, replication in an adequately powered, randomized controlled trial is required before definitive conclusions can be drawn.

Transitioning patients taking clozapine from the public to private/GP shared-care setting: barriers and criteria.

OBJECTIVE: The aim of this study was to explore the barriers to transitioning patients taking clozapine from the public to private psychiatrist or general practitioner (GP) shared-care setting, as well as the criteria used by staff to identify patients suitable for transitioning. METHOD: The experience of clinicians managing people taking clozapine was explored through circulation of a feedback questionnaire. The clozapine transition questionnaire (CTQ) was developed as the primary measure following extensive consultation with clinical staff with expertise in clozapine treatment. A total of 215 clinicians were sent questionnaires (60 community mental health service staff, 120 private psychiatrists registered to prescribe clozapine, and 35 GPs from the Bayside Health clozapine GP shared-care programme), with overall 80 (46.2%) returned. RESULTS: Over 64% of participants had managed patients who had been transitioned from public to private psychiatrist or GP shared-care settings. Around half of these said that it was a 'worthwhile treatment option' and that 'it went smoothly' and 'the patient was satisfied'. The most significant barriers to successful transitioning were the cost of private service, the patient's level of disorganization, and the need for ongoing care coordination. The most important criteria for transitioning patients was compliance with medication, ability to independently attend appointments and access appropriate pharmacies to receive medication, and willingness to transition out of the public system. CONCLUSIONS: Transitioning suitable public psychiatric patients taking clozapine into private psychiatrist/GP shared-care offers an important model to improve the efficiency and effectiveness of care, but requires careful planning, preparation, and monitoring to ensure sustained success.

Psychometric properties of a scale to measure investment in the sick role: the Illness Cognitions Scale.

RATIONALE, AIMS AND OBJECTIVES: A person's beliefs about their illness may contribute to recovery and prognosis. Some degree of acceptance of illness and its impact is necessary to integrate the presence of a chronic disorder into one's lifestyle and adhere to necessary components of illness management; however, some individuals can become 'stuck' and have difficulty adjusting out of the sick role. Inventories exist to measure illness cognitions, attitudes and behaviours as they relate to hypochondria and psychosomatic illness, but there is no extant measure of sick role inertia. We describe the psychometric properties of a new scale, the Illness Cognitions Scale (ICS), a metric of investment in the sick role. METHODS: The ICS was administered to 97 individuals with bipolar or schizoaffective disorder, and the psychometric properties of the scale measured. Dimensionality was assessed using Principal Components Analysis with Oblimin rotation. RESULTS: The scale has a strong internal consistency, with a Cronbach's alpha of 0.858. Results of a factor analysis suggested the presence of one main factor, with three other smaller, related sub-factors, capturing aspects of maladaptive illness beliefs. CONCLUSION: The ICS is a 17-item, internally validated scale measuring difficulty adjusting out of the sick role. The scale predominantly measures a single construct. Further research on external validity of the ICS is required as well as determination of the clinical significance and patient acceptability of the scale.

Sequential behavioral treatment of smoking and weight control in bipolar 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.

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

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12609001039279.