Mobile App for Smoking Cessation and Mental Health

Running, not enrolling · Phase 2

Conditions studied: Smoking Cessation, Mental Illness

In brief

Adults with serious mental illness (SMI) represent 5% of the United States population, yet account for 30% of all cigarettes smoked and are 2 to 3 times more likely to be dependent on nicotine compared with the general population. There are also significant disparities in quitting: 24% of lifetime smokers with SMI report not smoking within the past year compared with 52% of lifetime smokers without SMI. Two barriers partly explain the large disparity in smoking cessation rates between adults with and without SMI. First, there is a lack of high-quality, evidence-based interventions for smoking cessation in populations with SMI, which may be because adults with SMI are often excluded from clinical trials, despite evidence indicating that SMI is highly comorbid with smoking. Second, clinicians and staff within mental health settings generally do not have the resources or appropriate training to provide smoking cessation treatments to patients with SMI. Smartphone-based mobile health applications for smoking cessation could significantly improve cessation rates for adults with SMI. However, smoking cessation apps are underutilized by smokers with SMI partly because the apps are not designed for their unique needs. This study aims to conduct a pilot randomized controlled trial to evaluate the feasibility of an innovative, evidence-based smoking cessation app tailored for smokers with SMI. Seventy-five treatment-seeking smokers with SMI who will be referred from the Oklahoma Department of Mental Health and Substance Abuse Services (25 per group), a publicly funded outpatient psychiatry treatment program, will be randomly assigned to receive either (1) QuitGuide, a free smoking cessation app developed by the National Cancer Institute, (2) a smoking cessation app that tracks and automatically intervenes upon psychological distress during a quit attempt and delivers real-time intervention messages tailored to the current level of lapse risk and current lapse triggers (Smart-T Mental Health; STMH), or (3) the STMH app with additional messaging focused on increasing adherence to nicotine replacement medications (STMH+). All study conditions will be followed for 5 weeks (1-week pre-cessation and 4 weeks post-cessation), receive nicotine replacement therapy, and complete smartphone-based survey assessments using ecological momentary assessment procedures.

Key facts

Study ID

NCT04887558

Run by

University of Oklahoma

People needed

64

Starts

2021-12-14

Expected to finish

2028-12-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• valid residential address to mail study materials
• earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating > 6th grade English literacy level (required to complete EMAs; at least 88% of all individuals screened for our EMA studies have met this inclusion criterion)
• willingness to quit smoking 7 days after the randomization phone call
• currently smoke ≥ 10 cigarettes per day
• willing and medically eligible to use combination NRT
• agree to complete daily EMAs and thrice-weekly CO tests on a study provided or personal smartphone
• agree to complete the 5-week post-quit follow-up assessment (i.e., smartphone based quantitative survey and qualitative interview via phone call).

You may not qualify if…

• Individuals who score ≥ 8 on the Cognitive Impairment Test, which indicates severe cognitive impairment,
• Pregnant or intend to become pregnant during the study period.

Where it is running

• Oklahoma Department of Mental Health and Substance Abuse Services — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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