Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Description

The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).

Conditions

Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Persistent Depressive Disorder

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Study Overview

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Study Details

Study overview

The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Condition
Tobacco Use Disorder
Intervention / Treatment

-

Contacts and Locations

Buffalo

University at Buffalo, Buffalo, New York, United States, 14260-1660

Durham

Duke University, Durham, North Carolina, United States, 27705

Winston-Salem

Wake Forest Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
  • 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
  • 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
  • 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
  • 5. Age 18 and older;
  • 6. Willing and medically eligible to use NRT;
  • 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
  • 1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
  • 2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
  • 3. Being pregnant or the intention to become pregnant in the next 6 months;
  • 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
  • 5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
  • 6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Roger Vilardaga, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University

Study Record Dates

2025-04-01