Smoking Cessation Following Psychiatric Hospitalization
NCT02204956 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422
Last updated 2018-05-11
Summary
Smoking rates among individuals with psychiatric disorders are disproportionately higher than the general population. The majority of psychiatric hospitals ban smoking on hospital grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers in inpatient psychiatric settings are infrequently provided with referrals for cessation treatment on discharge (\< 1 %) and most resume smoking upon discharge. Therefore, the integration of effective cessation interventions within the current mental health treatment system is a public health priority.
The overall objective of this project is to adapt a Sustained Care (SusC) model to smokers with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted SusC intervention in real-world practice. We will test the hypothesis that, among smokers with SMI in inpatient psychiatric treatment (n = 422), SusC will result in significantly greater rates of cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a group that receives Usual Care (UC) about smoking cessation. Furthermore, we hypothesize that a higher proportion of SusC vs. UC patients will use evidence-based smoking cessation treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore the effect of SusC on health and health care utilization in the 12 months post-discharge (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room visits) and the effectiveness of SusC on smoking abstinence in patient diagnostic subgroups.
The expected outcome of this project is a demonstration of the effectiveness of a Sustained Care intervention for smoking cessation in individuals with severe mental illness (SMI) following psychiatric hospitalization. Future studies could extend these findings to individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall, this research would have a significant positive public health impact that will move us closer to the long-term goal of dissemination and integration of the Sustained Care model to increase smoking cessation and decrease smoking related morbidity and mortality in people with severe mental illness.
Conditions
- Nicotine Dependence
Interventions
- BEHAVIORAL
-
Sustained Care
The Sustained Care intervention includes four main components: 1. a 40-minute individual session about quitting smoking during the hospital stay; 2. a 90-day telephone-based and text messaging program that provides support regarding smoking and nicotine patch use; 3. the opportunity, during the automated calls and texts to be transferred to quit smoking resources, including live telephone quit coaching counseling, web and text-based quit coaching resources; and 4. an 8-week supply of nicotine patches, provided at no cost.
- BEHAVIORAL
-
Usual Care
Usual Care includes a brief, 5 - 10 minute education session about quitting smoking, delivered by a hospital nurse during the hospital stay. Written handouts to reinforce the educational session will also be provided.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
University of Texas at Austin
lead OTHER
Principal Investigators
-
Nancy A. Rigotti, M.D. · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2018-06-30
- Completion
- 2019-06-30
Countries
- United States
Study Locations
More Related Trials
-
Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
NCT00968513 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
NCT05045326 ·Status: UNKNOWN ·Phase: NA
-
Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
NCT03069482 ·Status: COMPLETED ·Phase: PHASE1
-
Smoking Cessation for Depressed Smokers
NCT00494728 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
NCT01779440 ·Status: COMPLETED ·Phase: NA
-
Early Tobacco Abstinence - 5
NCT00224965 ·Status: TERMINATED ·Phase: PHASE1
-
Helping Those With Mental Illness Quit Smoking
NCT01783912 ·Status: COMPLETED ·Phase: PHASE4
-
Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
NCT02845440 ·Status: COMPLETED ·Phase: NA
-
Smoking Cessation in Alcoholics
NCT00963482 ·Status: COMPLETED ·Phase: NA
-
Proactive Outreach for Smoking Treatment
NCT04988477 ·Status: COMPLETED ·Phase: PHASE2
-
Targeted Intervention for Bipolar Smokers
NCT01550029 ·Status: UNKNOWN ·Phase: NA
-
Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients
NCT03230955 ·Status: COMPLETED ·Phase: NA
-
Smoking Cessation Treatment for Depressed Smokers
NCT03163056 ·Status: COMPLETED ·Phase: NA
-
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
NCT01791803 ·Status: COMPLETED ·Phase: NA
-
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
NCT02576899 ·Status: COMPLETED ·Phase: PHASE1
-
Smoking Cessation for Depression and Anxiety Treatment
NCT02002858 ·Status: COMPLETED ·Phase: PHASE1
-
Mood Management Phone Counseling in Smoking Cessation
NCT00500877 ·Status: COMPLETED ·Phase: PHASE2
-
Smoking Interventions for Hospital Patients
NCT01177176 ·Status: COMPLETED ·Phase: NA
-
Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)
NCT00004551 ·Status: COMPLETED ·Phase: PHASE4
-
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
NCT01714323 ·Status: COMPLETED ·Phase: NA
-
Smoking Cessation in Hospitalized Smokers
NCT01289275 ·Status: COMPLETED ·Phase: PHASE4
-
Contingency Management for Smoking Abstinence With Adolescent Smokers
NCT01056588 ·Status: COMPLETED ·Phase: NA
-
Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
NCT04523948 ·Status: UNKNOWN
-
An Integrated Approach to Smoking Cessation in Severe Mental Illness (SMI)
NCT00690131 ·Status: COMPLETED ·Phase: NA
-
The Impact of Successful Quitting Smoking After Intensive Smoking Cessation Interventions on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish Smoking Cessation Database
NCT06967636 ·Status: COMPLETED