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Behavioural Intervention

Smoking Cessation App for Mental Illness (Smart-T MH Trial)

Phase 2
Recruiting
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Smart-T MH Trial Summary

This trial will test the feasibility of a smoking cessation app tailored for smokers with serious mental illness, who are otherwise underserved by current cessation programs.

Who is the study for?
This trial is for adults with serious mental illness who smoke at least 10 cigarettes a day, are willing to use nicotine replacement therapy (NRT), and can complete daily mobile surveys and carbon monoxide tests. They must be able to read English at a 6th-grade level or higher. Pregnant individuals or those with severe cognitive impairment cannot participate.Check my eligibility
What is being tested?
The study compares three smoking cessation aids: QuitGuide app plus NRT, Smart-T Mental Health app plus NRT, and an enhanced version of the Smart-T app that also promotes adherence to NRT. Participants will use these aids over five weeks while attempting to quit smoking.See study design
What are the potential side effects?
Potential side effects from using the apps may include frustration or stress if technical issues arise or if participants find it challenging to follow the program. Side effects from nicotine replacement therapy can include skin irritation from patches, sleep problems, nausea, heart palpitations, muscle pain and dizziness.

Smart-T MH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemically-Verified Smoking Cessation
Secondary outcome measures
Change in anxiety
Change in cessation motivation
Change in cigarette availability
+5 more

Smart-T MH Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Smart-T Mental Health+ and NRTExperimental Treatment1 Intervention
Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. During the pre-quit and post-quit period, the app will also send messages that encourage the use of the nicotine patch and lozenges according to recommended practices. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free NRT.
Group II: Smart-T Mental Health and NRTExperimental Treatment1 Intervention
Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive NRT.
Group III: NCI QuitGuide and NRTActive Control1 Intervention
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free NRT.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,848 Total Patients Enrolled
Michael Businelle, PhDStudy DirectorTSET Health Promotion Research Center
2 Previous Clinical Trials
226 Total Patients Enrolled

Media Library

QuitGuide + NRT (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04887558 — Phase 2
Smoking Cessation Research Study Groups: Smart-T Mental Health+ and NRT, NCI QuitGuide and NRT, Smart-T Mental Health and NRT
Smoking Cessation Clinical Trial 2023: QuitGuide + NRT Highlights & Side Effects. Trial Name: NCT04887558 — Phase 2
QuitGuide + NRT (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887558 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what quantity is this research project accepting participants?

"Absolutely. According to clinicaltrials.gov, this medical trial is currently enrolling patients with the initial posting date of December 14th 2021 and most recent edit on March 25th 2022. The study requires 75 participants from a single site."

Answered by AI

Has Smart-T Mental Health and NRT attained authorization from the FDA?

"The safety of Smart-T Mental health and NRT was rated a 2 due to the clinical data collected in Phase 2 trials, which suggested that this intervention may be safe but has yet to demonstrate efficacy."

Answered by AI

Does the age requirement for this research encompass persons over two decades of life?

"According to this clinical trial's inclusion criteria, only individuals between 18 and 100 years old can apply. This study is one out of 468 trials; 110 are specifically for children below the age of 18 and 358 cater to seniors over 65."

Answered by AI

Does this clinical trial currently accept new participants?

"Clinicaltrials.gov data attests to the fact that this trial is still accepting applicants, with initial posting taking place on December 14th 2021 and last revised records being dated March 25th 2022."

Answered by AI

What qualifications must be met to join this clinical investigation?

"This clinical trial seeks 75 individuals with mental conditions aged between 18 and 100. Vital requirements for qualifying include a commitment to cease smoking within 7 days of being randomly selected, smokes ≥ 10 cigarettes per day, can use combination NRT as medically allowed, is prepared to engage in daily EMAs and thrice-weekly CO tests either on given or personal smartphone devices, agrees to complete the 5-week post treatment survey (which consists of both quantitative data collection via smartphones and qualitative interviews over phone)."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Oklahoma Department of Mental Health and Substance Abuse Services
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Oklahoma Department of Mental Health and Substance Abuse Services: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Mobile App for Smoking Cessation and Mental Health
2021. "Mobile App for Smoking Cessation and Mental Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887558.
All > Mental Illness > Smoking Cessation
~15 spots leftby Dec 2024
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