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

NCT04367506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-07-15

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Sheppard Pratt Health System

    collaborator OTHER

  • Truth Initiative

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2024-03-25
Completion
2024-03-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367506 on ClinicalTrials.gov