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

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

• Status: Recruiting
• Conditions: Tobacco Cessation
• Intervention / Treatment: Behavioral: BecomeAnEX; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Bennett, Ph.D.; Phone Number: 410-706-2490; Email: mbennett@som.umaryland.edu
• Study Contact Backup: Name: Brian Brandler; Phone Number: 410-402-6425; Email: bbrandler@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
      • Contact: Brian Brandler; Phone Number: 410-402-6425; Email: bbrandler@som.umaryland.edu
      • Contact: Melanie E Bennett, Ph.D.; Phone Number: 410-706-2490; Email: mbennett@som.umaryland.edu
      • Principal Investigator: Melanie Bennett, Ph.D.
    • Baltimore, Maryland, United States, 21021
      • Recruiting
      • Melanie Bennett
      • Contact: Melanie Bennett; Phone Number: 410-706-0892; Email: mbennett@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Rate of recruitment	3 months
Feasibility of registration	Time to register with the web based intervention	3 months
Acceptability	Satisfaction with the web based intervention using the Services Satisfaction Questionnaire	3 months
Website utilization	Time on website	3 months
Smoking abstinence	Self-report 7-day point prevalence abstinence	3 months
Craving	Tobacco Cravings Questionnaire	3 months
Self-efficacy	Smoking Situations Confidence Questionnaire	3 months
Motivation to remain abstinent	Abstinence-Related Motivational Engagement Scale	3 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Sheppard Pratt Health System; Truth Initiative

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 1R34MH120142 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No