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Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial.

ABSTRACT: BACKGROUND:The rate of tobacco use among people with mental illness is nearly twice that of the general population. Psychotropic medications for tobacco cessation are relatively expensive for most Kenyans. Behavioral counseling and group therapy are effective lower cost strategies to promote tobacco cessation, yet have not been studied in Kenya among individuals with concomitant mental illness. METHODS/DESIGN:One hundred tobacco users with mental illness who were part of an outpatient mental health program in Nairobi, Kenya were recruited and allocated into intervention and control groups of the study (50 users in intervention group and 50 users in control group). Participants allocated to the intervention group were invited to participate in 1 of 5 tobacco cessation groups. The intervention group received the 5As (Ask, Advise, Assess, Assist and Arrange) and tobacco cessation group behavioral intervention, which included strategies to manage cravings and withdrawal, stress and anxiety, and coping with depression due to withdrawal; assertiveness training and anger management; reasons to quit, benefits of quitting and different ways of quitting. Individuals allocated to the control group received usual care. The primary outcome was tobacco cessation at 24?weeks, measured through cotinine strips. Secondary outcomes included number of quit attempts and health-related quality of life. DISCUSSION:This study will provide evidence to evaluate the efficacy and safety of a tobacco cessation group behavioral intervention among individuals with mental illness in Kenya, and to inform national and regional practice and policy. TRIAL REGISTRATION:Trial registration number: NCT04013724. Name of registry: ClinicalTrials.gov. URL of registry: https://register.clinicaltrials.gov Date of registration: 9 July 2019 (retrospectively registered). Date of enrolment of the first participant to the trial: 5th September 2017. Protocol version: 2.0.

SUBMITTER: Olando Y

PROVIDER: S-EPMC6921564 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial.

Olando Yvonne Y Kuria Mary M Mathai Muthoni M Huffman Mark D MD

BMC public health 20191218 1

<h4>Background</h4>The rate of tobacco use among people with mental illness is nearly twice that of the general population. Psychotropic medications for tobacco cessation are relatively expensive for most Kenyans. Behavioral counseling and group therapy are effective lower cost strategies to promote tobacco cessation, yet have not been studied in Kenya among individuals with concomitant mental illness.<h4>Methods/design</h4>One hundred tobacco users with mental illness who were part of an outpat ...[more]

PMID: 31852536

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Project description:Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness.We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months.Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events.A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Project description:BackgroundImplementation researchers have sought ways to use simulations to support the core components of implementation, which typically include assessing the need for change, designing implementation strategies, executing the strategies, and evaluating outcomes. The goal of this paper is to explain how agent-based modeling could fulfill this role.MethodsWe describe agent-based modeling with respect to other simulation methods that have been used in implementation science, using non-technical language that is broadly accessible. We then provide a stepwise procedure for developing agent-based models of implementation processes. We use, as a case study to illustrate the procedure, the implementation of evidence-based smoking cessation practices for persons with serious mental illness (SMI) in community mental health clinics.ResultsFor our case study, we present descriptions of the motivating research questions, specific models used to answer these questions, and a summary of the insights that can be obtained from the models. In the first example, we use a simple form of agent-based modeling to simulate the observed smoking behaviors of persons with SMI in a recently completed trial (IDEAL, Comprehensive Cardiovascular Risk Reduction Trial in Persons with SMI). In the second example, we illustrate how a more complex agent-based approach that includes interactions between patients, providers and site administrators can be used to provide guidance for an implementation intervention that includes training and organizational strategies. This example is based in part on an ongoing project focused on scaling up evidence-based tobacco smoking cessation practices in community mental health clinics in Maryland.ConclusionIn this paper we explain how agent-based models can be used to address implementation science research questions and provide a procedure for setting up simulation models. Through our examples, we show how what-if scenarios can be examined in the implementation process, which are particularly useful in implementation frameworks with adaptive components.

Project description:IntroductionSexual minority populations-particularly gay/lesbian and bisexual women-use tobacco at higher rates than their heterosexual peers. Evidence-based biopsychosocial interventions for tobacco cessation are available; however, research is lacking on the specific barriers to tobacco cessation in these populations. The purpose of this study is to describe the psychological, normative, and environmental barriers to cessation that disproportionally affect sexual minority tobacco users.MethodsData from wave 1 of the Population Assessment of Tobacco and Health were used to explore differences by sexual identity across psychosocial barriers and facilitators of tobacco cessation. The analytic sample consisted of current tobacco users (including cigarettes, e-cigarettes, cigars, cigarillos, pipes, hookah, dissolvable snus, and smokeless products). Psychosocial barriers/facilitators were modeled using logistic regression analyses, controlling for age, race/ethnicity, poverty, education, census region, and urbanicity and were stratified by sex. Models accounted for the complex study design and nonresponse.ResultsSubstance use and internalizing/externalizing behavioral problems were more common among gay/bisexual men. Bisexual, but not gay/lesbian, women also had higher odds of these behavioral problems. Bisexual men and women reported less normative pressure to quit than their heterosexual peers (no differences in gay/lesbian tobacco users). Gay men had more environmental barriers to quit, being more likely to receive tobacco promotion materials, and live with another tobacco user.ConclusionsSeveral barriers to tobacco cessation were identified as disproportionally affecting sexual minority groups in this study; however, there were considerable differences between sexual minority men and women, as well as between gay and bisexual participants.ImplicationsSeveral important psychological, normative, and environmental barriers to tobacco cessation were identified that disproportionally affect sexual minorities. There was considerable heterogeneity in the prevalence and relative difference of these barriers across sexual minority subgroups, suggesting that community-based tobacco cessation programs should be responsive to differences in gay and bisexual men and women.

Project description:BackgroundTobacco smoking is highly prevalent among persons with serious mental illness (SMI) and is the largest contributor to premature mortality in this population. Evidence-based smoking cessation therapy with medications and behavioral counseling is effective for persons with SMI, but few receive this treatment. Mental health providers have extensive experience working with clients with SMI and frequent treatment contacts, making them well positioned to deliver smoking cessation treatment. However, few mental health providers feel adequately trained to deliver this treatment, and many providers believe that smokers with SMI are not interested in quitting or have concerns about the safety of smoking cessation pharmacotherapy, despite substantial evidence to the contrary.ObjectiveWe present the protocol for the pilot "IMPACT" (Implementing Action for Tobacco Smoking Cessation Treatment) study, which aims to pilot test a multicomponent implementation intervention to increase the delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics.MethodsWe are using a prepost observational design to examine the effects of an implementation intervention designed to improve mental health providers' delivery of the following four evidence-based practices related to smoking cessation treatment: (1) assessment of smoking status, (2) assessment of willingness to quit, (3) behavioral counseling, and (4) pharmacotherapy prescribing. To overcome key barriers related to providers' knowledge and self-efficacy of smoking cessation treatment, the study will leverage implementation strategies including (1) real-time and web-based training for mental health providers about evidence-based smoking cessation treatment and motivational interviewing, including an avatar practice module; (2) a tobacco smoking treatment protocol; (3) expert consultation; (4) coaching; and (5) organizational strategy meetings. We will use surveys and in-depth interviews to assess the implementation intervention's effects on providers' knowledge and self-efficacy, the mechanisms of change targeted by the intervention, as well as providers' perceptions of the acceptability, appropriateness, and feasibility of both the evidence-based practices and implementation strategies. We will use data on care delivery to assess providers' implementation of evidence-based smoking cessation practices.ResultsThe IMPACT study is being conducted at 5 clinic sites. More than 50 providers have been enrolled, exceeding our recruitment target. The study is ongoing.ConclusionsIn order for persons with SMI to realize the benefits of smoking cessation treatment, it is important for clinicians to implement evidence-based practices successfully. This pilot study will result in a set of training modules, implementation tools, and resources for clinicians working in community mental health clinics to address tobacco smoking with their clients. Trial Registration: ClinicalTrials.gov NCT04796961; https://clinicaltrials.gov/ct2/show/NCT04796961.Trial registrationClinicalTrials.gov NCT04796961; https://clinicaltrials.gov/ct2/show/NCT04796961.International registered report identifier (irrid)DERR1-10.2196/44787.

Project description:BackgroundPeople with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer.ObjectivesTo review the effects of smoking cessation advice for people with serious mental illness.Search methodsWe searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studiesSelection criteriaWe planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information.Data collection and analysisThe review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review.Main resultsWe did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible.Authors' conclusionsPeople with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.

Project description:BackgroundIn a previous study, participation in a 16-week reverse integrated care and group behavioral and educational intervention for individuals with diabetes and serious mental illness was associated with improved glycemic control (hemoglobin A1c) and BMI. To inform future implementation efforts, more information about the effective components of the intervention is needed.ObjectiveThe goal of this study is to identify the aspects of the intervention participants reported to be helpful and to evaluate the predictors of outcomes.MethodsThis study involved qualitative evaluation and post hoc quantitative analysis of a previous intervention. Qualitative data were collected using semistructured interviews with 69% (24/35) of the individuals who attended 1 or more group sessions and 35% (9/26) of the individuals who consented but attended no sessions. Quantitative mixed effects modeling was performed to test whether improved diabetes knowledge, diet, and exercise or higher group attendance predicted improved hemoglobin A1c and BMI. These interview and modeling outcomes were combined using a mixed methods case study framework and integrated thematically.ResultsIn qualitative interviews, participants identified the application of health-related knowledge gained to real-world situations, accountability for goals, positive reinforcement and group support, and increased confidence in prioritizing health goals as factors contributing to the success of the behavioral intervention. Improved knowledge of diabetes was associated with reduced BMI (β=-1.27, SD 0.40; P=.003). No quantitative variables examined were significantly associated with improved hemoglobin A1c levels.ConclusionsIn this mixed methods analysis of predictors of success in a behavioral diabetes management program, group participants highlighted the value of positive reinforcement and group support, accountability for goals set, and real-world application of health-related knowledge gained. Improved diabetes knowledge was associated with weight loss.

Dataset Information

Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial.

Publications

Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial.

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