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— Status: Withdrawn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Withdrawn |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.