COMPLETED

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Quick Facts

Study Start:2021-09-21
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05030272

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
  2. 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
  3. 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
  4. 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
  5. 5. Age 18 and older;
  6. 6. Willing and medically eligible to use NRT;
  7. 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
  8. 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.
  9. 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);
  10. 3. Being pregnant or the intention to become pregnant in the next 6 months;
  11. 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
  12. 5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
  13. 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).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Roger Vilardaga, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University

Study Locations (Sites)

University at Buffalo
Buffalo, New York, 14260-1660
United States
Duke University
Durham, North Carolina, 27705
United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Roger Vilardaga, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-21
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-09-21
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

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