Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

NCT06837220 | Recruiting

• 2 other identifiers: IRB24-2154P50MD017349
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to: partner with Respiratory Health Association and determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, treatment programs and adults who smoke (AWS) in Chicago. This will be accomplished by establishing a community advisory board (CAB) and pilot testing a community-informed smoking cessation treatment within a community behavioral health organization to determine its feasibility after addressing implementation issues.

Conditions

Nicotine Use Disorder; Smoking Cessation; Smoking Cessation Intervention

Keywords

smoking; smoking cessation; nicotine; nicotine use disorder; quitting smoking; quitting nicotine; respiratory health; telehealth; virtual; tobacco; tobacco treatment; community; behavioral health; chicago; group therapy; disparities; adults who smoke; cigarettes; tobacco cessation; cessation; abstinence; substance use; substance abuse; addiction; counseling; health counseling; health communication

Outcome Measures

Primary Outcomes (3)

• Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session

  Investigators will consider the initial pilot period of the enhanced intervention successful if the team enrolls (attend one session) and retains (attend four or more sessions) at least three participants in the pilot treatment across three months

  3 months

• Feasibility will be assessed by calculating the portion of people who enroll (attend at least on session) and complete 4+ sessions versus those who drop out before finishing 4 sessions as assessed by session sign-in

  Investigators will consider the intervention design to be feasible if fewer than 40% of enrollees drop out after their first attended session.

  3 months

• A modified version of the Client Satisfaction Questionnaire (CSQ) will assess intervention acceptability.

  This measure is a 10-point Likert scale (0=not at all, 10=very much) that assesses items such as intervention quality, effectiveness, and intrusiveness. For acceptability, the study team predicts at least 75% of participants will rate the intervention as acceptable via post-treatment survey (CSQ).

  End of treatment (e.g., 3 months or fourth session attended, whichever comes first)

Secondary Outcomes (4)

• Change in number of cigarettes consumed per day

  Through study completion, an average of 3 months

• Use of nicotine replacement therapy and FDA-approved cessation medication

  Through study completion, an average of 3 months

• Number of quit attempts

  Through study completion, an average of 3 months

• Motivation to change smoking behavior via Contemplation Ladder

  Through study completion, an average of 3 months

Study Arms (1)

Pilot Intervention

EXPERIMENTAL

The participants in this arm will take part in a pilot test of a community-targeted smoking cessation treatment. This treatment will be evidence-based smoking treatment using cognitive behavioral and motivational strategies implemented according to findings from Phase 1 of this study. The original intervention has four core sessions that will be modified accordingly to fit community needs. Participants will complete pre- and post-session questionnaires regarding their smoking status, quit attempts, use of smoking cessation aids, and other surveys.

Behavioral: Enhanced Courage to Quit

Interventions

Enhanced Courage to Quit BEHAVIORAL

Participants will engage in a version of the smoking cessation treatment "Courage to Quit" that has been optimized for implementation in community behavioral health clinics. The group will run over a period of 3 months, where participants will learn behavioral and cognitive skills for smoking cessation and/or reduction. Special attention will be given to the unique needs of the community, such as technology options or more flexible treatment models. The goal of this intervention is to prove that it is feasible to implement, and can create enhanced engagement and smoking outcomes for adults who smoke (AWS) and have fewer socioeconomic resources.

Pilot Intervention

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Identify as someone who currently smokes combustible cigarettes (at least 1 cigarette per day) on each day for the past month
• Report interest in quitting cigarettes (at least 6/10 scale in interest of quitting)
• Age 18 or older, ability to understand the English language, willing and able to provide informed consent
• Stable residence and contact information throughout the follow up period

You may not qualify if:

• Non-daily or intermittent cigarette use
• No interest in quitting smoking
• Unstable residence/not staying in Chicago for duration of study period
• Current untreated severe substance use disorder (with the exception of tobacco use) or past-year serious untreated psychiatric illness (e.g. schizophrenia, bipolar disorder, obsessive compulsive disorder, unspecified psychosis, past-year suicide attempt)

Sponsors & Collaborators

• University of Chicago: lead
• Respiratory Health Association: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Smoking; Tobacco Use Cessation; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Central Study Contacts

Emma Brett, PhD

CONTACT

773-834-5341; ebrett@bsd.uchicago.edu

Sophie Miller, BS

CONTACT

sophie.miller@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 20, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)