Development of a Multicomponent Mind-Body Intervention for Adults with Serious Mental Illness Who Smoke Cigarettes

About This Grant

PROJECT SUMMARY AND ABSTRACT Approximately 15 million adults in the United States have serious mental illness (SMI). These individuals are likely to die 10 to 20 years earlier than people in the general population, due in large part to tobacco-related illness. Despite interest in and effort to quit smoking, adults with SMI have difficulty quitting smoking and sustaining abstinence with existing treatments. Novel interventions are needed to address the complex needs of this population, such as high stress, increased dependence and withdrawal symptoms, psychiatric and physical symptoms, and social isolation. There is robust evidence that mind-body interventions are among the most efficacious treatments for addictive behaviors and there are clear benefits of mind-body interventions for adults with SMI to address key barriers to tobacco cessation. Accordingly, we propose to develop a virtual, group-based multicomponent mind-body intervention integrating mind-body skills and social support with gold-standard tobacco treatment (i.e., medication and counseling) to improve tobacco cessation for adults with SMI. Eligible participants include those: ≥ 21 years old with a current diagnosis of SMI (severe recurrent major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar disorder), on a stable medication regimen and presenting with stable psychiatric illness for at least 8 weeks, currently receiving care from a mental health professional, smoking ≥ 5 cigarettes/day in the past week, and living in Massachusetts. The proposed study has three specific aims: Aim 1: To develop a 12-week virtual, group-based, multicomponent MBI for tobacco cessation that integrates existing evidence-based behavioral counseling and tobacco cessation medication with mind-body skills and social support, tailored for adults with SMI. To guide manual/protocol development, we will conduct individual interviews with mental health clinicians (N=10) and caregivers (N=10), and patient focus groups (N=24); Aim 2: To refine the MBI in a single-arm open pilot trial with N=16 adults with SMI who smoke cigarettes (N=2 groups of 8). We will use ecological momentary assessments (EMA) to gain insights into their use of treatment skills in their daily lives. We will modify the intervention and assessments based on participants’ engagement and based on their post-group individual exit interviews. Aim 3: To conduct a pilot RCT to assess the feasibility and acceptability of the proposed treatment (a novel 12-week virtual, group-based MBI for tobacco cessation (N=32; 4 groups of 8) compared to an active time-matched control intervention (N=32; 4 groups of 8)) and the feasibility and acceptability of the RCT design to informed the design of a full-scale effectiveness RCT. In sum, I propose to develop and test a multicomponent mind-body intervention for adults with serious mental illness who smoke, leveraging training in 1) behavioral and mind-body intervention development, 2) mixed methods research, and 3) clinical trial design and longitudinal assessment. An anticipated outcome of this proposal is the development of a novel mind-body tobacco cessation intervention for adults with SMI. A long- term goal is to promote evidence-based tobacco cessation treatments for adults with SMI.