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

NCT04367506 | Completed Results

• 1 other identifier: 1R34MH120142
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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 test a digital intervention adapted to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting. Such an intervention could bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.

Conditions

Tobacco Cessation

Outcome Measures

Primary Outcomes (4)

• Smoking Abstinence

  Self-report 7-day point prevalence abstinence

  1 month

• Craving

  Craving was assessed with 11 items from the Tobacco Cravings Questionnaire (TCQ). Possible scores range from 11-77, with higher scores indicating greater tobacco craving.

  1 month

• Self-efficacy

  The 9-item Abstinence Self-Efficacy Questionnaire (ASEQ) measured confidence to resist smoking across situations and emotional states. Possible scores range from 9-45, with higher scores indicating greater abstinence self-efficacy.

  1 month

• Abstinence-Related Motivational

  The 16-item Abstinence-Related Motivational Engagement (ARME) assessed motivation to maintain smoking abstinence. Possible scores range from 16-112, with higher scores indicating greater abstinence-related motivation.

  1 month

Study Arms (2)

BecomeAnEX

EXPERIMENTAL

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; Behavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Interventions

BecomeAnEX BEHAVIORAL

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.

BecomeAnEX

Usual Care BEHAVIORAL

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.

BecomeAnEX; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truth Initiative: collaborator
• University of Maryland, Baltimore: lead
• Sheppard Pratt Health System: collaborator

Study Sites (2)

Melanie Bennett

Baltimore, Maryland, 21021, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

The study was conducted during the COVID-19 pandemic, which disrupted hospital operations and slowed recruitment. Consequently, we did not meet recruitment targets and ended with a smaller sample size than projected. The small sample size and low follow-up rate are major limitations, although these limitations perhaps were to be expected given the study setting and a predominantly unemployed sample with high rates of poverty and chaotic life circumstances.

Results Point of Contact

• Title: Dr. Melanie Bennett
• Organization: Unive

mbennett@som.umaryland.edu

4107062490

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot randomized controlled trial to examine indicators of feasibility, acceptability, target mechanisms, and preliminary efficacy.

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: September 6, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-06

Locations

US (2)