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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04340102
Other study ID # 1R21CA237468-01A1
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2020
Est. completion date June 2022

Study information

Verified date November 2020
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BecomeAnEx
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.

Locations

Country Name City State
United States University of Maryland School of Medicine Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
University of Maryland, Baltimore Sheppard Pratt Health System, Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of recruitment Rate of recruitment 2 months
Primary Feasibility of registration Time to register with the web based intervention 2 months
Primary Acceptability Satisfaction with the web based intervention using the Client Satisfaction Questionnaire 2 months
Primary Acceptability Satisfaction with the web based intervention using the Services Satisfaction Questionnaire 2 months
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