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Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness

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ClinicalTrials.gov Identifier: NCT04340102
Recruitment Status : Withdrawn (Study was not funded.)
First Posted : April 9, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
Sheppard Pratt Health System
Truth Initiative
Information provided by (Responsible Party):
Melanie Bennett, University of Maryland, Baltimore

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Cessation Behavioral: BecomeAnEx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This project has two phases. Phase 1: Adapt BecomeAnEX, conduct usability testing, and train digital coaches. Phase 2: Implement adapted BecomeAnEx with 60 individuals with a mental health disorder who are hospitalized on the inpatient psychiatric unit at the University of Maryland Medical Center.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: 2 months ]
    Rate of recruitment

  2. Feasibility of registration [ Time Frame: 2 months ]
    Time to register with the web based intervention

  3. Acceptability [ Time Frame: 2 months ]
    Satisfaction with the web based intervention using the Client Satisfaction Questionnaire

  4. Acceptability [ Time Frame: 2 months ]
    Satisfaction with the web based intervention using the Services Satisfaction Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340102


Locations
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United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Sheppard Pratt Health System
Truth Initiative
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Responsible Party: Melanie Bennett, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04340102    
Other Study ID Numbers: 1R21CA237468-01A1
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders