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Adapting a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness

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ClinicalTrials.gov Identifier: NCT04367506
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 28, 2021
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 Behavioral: Usual Care Not Applicable

Detailed Description:
Persons with serious mental illness (SMI) die on average 10-15 years earlier than those in the general population. Smoking is the strongest risk factor for their elevated mortality. Helping SMI smokers to quit is an urgent and unmet need. The hospital is an optimal setting to provide smoking cessation services. Hospital admissions for SMI are common with more than 1.2 million inpatient stays for schizophrenia and mood disorders per year in the US. Hospitalized patients experience required abstinence, are available for counseling, and can try cessation medications in a supportive setting. The challenge is how to engage SMI patients in cessation services post-discharge. An easy-to-access digital intervention is a scalable and sustainable way to bridge the inpatient-to-outpatient gap and to promote sustained abstinence. Digital interventions can deliver all elements of cessation treatment and yield quit rates comparable to face to face and telephonic interventions. SMI patients use and benefit from technology-based interventions but currently there is no digital smoking cessation program addressing their needs. This R34 application will adapt a proven digital intervention, BecomeAnEX (EX), developed and run by Truth Initiative for over 10 years. Its core components are real-time one on one coaching via live chat, nicotine replacement therapy decision support and delivery, personalized quit plans, a large online social network for peer support, a robust and fully integrated text message program, and tailored email messaging. Adaptation will ensure that EX addresses the specific challenges of SMI smokers and is in line with principles of mental health recovery. In Aim 1 the investigators will develop and obtain preliminary feedback about EX-SMI, a version of EX adapted for SMI patients. A priori target mechanisms are motivation, abstinence self-efficacy, and cravings. In Aim 2 the investigators will conduct a one-arm pilot trial and obtain feedback from 20 SMI smokers recruited during psychiatric hospitalization and followed up at 2-weeks and 1-month post-discharge. Feasibility and acceptability will be assessed via participant feedback regarding their intervention experience, changes in motivation, self-efficacy and cravings, and automated tracking data on EX-SMI use post-discharge. In Aim 3, 90 SMI smokers recruited during psychiatric hospitalization will be randomized to usual care or to a revised version of EX-SMI and followed for 3 months after the hospital stay. The investigators will compare the feasibility/acceptability of EX-SMI, measure intervention impact on target mechanisms, and obtain initial estimates of efficacy on 7-day point prevalence abstinence. This pilot work directly addresses priorities of this RFA in refining and optimizing an efficacious intervention for a new target population. Ultimately, this program of research could have a powerful public health impact by increasing smoking cessation among persons with SMI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This project has three phases. Phase 1: Adapt BecomeAnEX, conduct usability testing (n=10), and train digital coaches. Phase 2: Conduct a 1-arm pilot trial of the adapted BecomeAnEX (n=20). Phase 3: Conduct a pilot randomized controlled trial (n=90) to examine indicators of feasibility, acceptability, target mechanisms, and preliminary efficacy.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapting a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

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.
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.

Behavioral: Usual Care
Usual care represents what hospitalized psychiatric patients normally receive in terms of smoking cessation: brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.

Active Comparator: Usual Care
Brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
Behavioral: Usual Care
Usual care represents what hospitalized psychiatric patients normally receive in terms of smoking cessation: brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: 3 months ]
    Rate of recruitment

  2. Feasibility of registration [ Time Frame: 3 months ]
    Time to register with the web based intervention

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

  4. Website utilization [ Time Frame: 3 months ]
    Time on website

  5. Smoking abstinence [ Time Frame: 3 months ]
    Self-report 7-day point prevalence abstinence

  6. Craving [ Time Frame: 3 months ]
    Tobacco Cravings Questionnaire

  7. Self-efficacy [ Time Frame: 3 months ]
    Smoking Situations Confidence Questionnaire

  8. Motivation to remain abstinent [ Time Frame: 3 months ]
    Abstinence-Related Motivational Engagement Scale



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 3 times/week post-discharge and ownership of mobile device with text messaging plan post-discharge.
  • Discharge destination within 1-hour of SPH given that Aim 3 involves biochemical verification (carbon monoxide testing).
  • Reading competence as demonstrated by a score of >= 37 on the Word Reading subtest of the Wide Range Achievement Test - 4th Edition (WRAT-4)168 to ensure the ability to engage in the intervention.

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): NCT04367506


Contacts
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Contact: Melanie Bennett, Ph.D. 410-706-2490 mbennett@som.umaryland.edu
Contact: Brian Brandler 410-402-6425 bbrandler@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Melanie E Bennett, Ph.D.    410-706-2490    mbennett@som.umaryland.edu   
Contact: Brian Brandler    410-402-6425    bbrandler@som.umaryland.edu   
Principal Investigator: Melanie Bennett, Ph.D.         
University of Maryland School of Medicine Recruiting
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: NCT04367506    
Other Study ID Numbers: 1R34MH120142 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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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