- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340102
Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
November 4, 2020 updated by: Melanie Bennett, University of Maryland, Baltimore
All patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge.
The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization.
The investigators believe this will bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
Study Overview
Detailed Description
Persons with serious mental illness (SMI, schizophrenia, bipolar disorder, recurrent depression) are a socioeconomically disadvantaged group and die on average 10-15 years earlier than those in the general population, many from cancer.
The prevalence of smoking in persons with SMI is approximately 3 times that in the general population; smoking is the is the strongest risk factor for elevated mortality in this population.
Psychiatric inpatient admissions are common in SMI and the hospital is an optimal place to provide smoking cessation services.
All patients are abstinent while in the hospital.
The key challenge is how to continue to engage these patients in cessation services to support continued abstinence.
While most receive refer to telephone quitline at discharge, quitlines are not as effective with SMI smokers and almost all return to smoking.
Introducing hospitalized SMI patients to cessation services that can be easily accessed when they leave the hospital offers the best chance of converting initial abstinence into sustained abstinence post-discharge.
A digital intervention that incorporates web-delivered evidence-based smoking cessation practices, digital coaching, and mobile text messaging is a scalable and sustainable way to bridge the inpatient to outpatient gap in cessation services.
Currently there is no digital cessation program that addresses the needs of SMI smokers.
The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization.
The investigators will build upon a well-established, evidence-based, cessation website, BecomeAnEX.org (EX), that offers individualized quit plans, an active social community, text and email messaging support, and digital coaching.
Integrating input from different stakeholders, the investigators will develop adaptations so that EX components and language are in line with principles of mental health recovery and will successfully engage SMI smokers with digital coaching that will support use of other EX services.
The investigators will develop automated and integrated procedures for identifying hospitalized SMI smokers and registering them with EX.
The investigators will then examine the feasibility and acceptability of the adapted intervention to engage and retain 60 smokers with SMI after hospital discharge.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or greater
- Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression)
- Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
- Interested in remaining quit after hospital discharge or quitting within the following 30 days
- Expected Internet use at least several times a week post-discharge and ownership of mobile device with text messaging plan post-discharge
- Sufficiently stable and cooperative to engage in the intervention, operationalized as not on a nursing observation level that indicates high acuity/safety concerns and has participated in a majority of hospital unit activities as documented in the chart during the hospital stay so far
Exclusion Criteria:
- Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
- Homeless prior to admission or anticipated to be homeless at discharge.
- Discharge to a residential setting where smoking is prohibited.
- Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BecomeAnEx
Participants will have three individual meetings with a research staff person while they are in the hospital.
At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital.
Participants will be given two weeks of nicotine replacement therapy when they leave the hospital.
Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital program.
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This research study is focused on a smoking cessation program called BecomeAnEx.
We are studying how to adapt BecomeAnEx for people with a mental health disorder who want to reduce or quit their tobacco smoking.
BecomeAnEx includes a website that provides education about smoking and quitting.
It also has a text messaging program that delivers personalized information.
Persons in the program have access to real-time digital coaching with a remote coach who has experience helping people quit smoking.
In addition, the program has an on-line community of current and former smokers that can provide support and encouragement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment
Time Frame: 2 months
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Rate of recruitment
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2 months
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Feasibility of registration
Time Frame: 2 months
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Time to register with the web based intervention
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2 months
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Acceptability
Time Frame: 2 months
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Satisfaction with the web based intervention using the Client Satisfaction Questionnaire
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2 months
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Acceptability
Time Frame: 2 months
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Satisfaction with the web based intervention using the Services Satisfaction Questionnaire
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2020
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 9, 2020
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21CA237468-01A1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on BecomeAnEx
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