Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

April 9, 2026 updated by: University of Chicago

Enhancing the Implementation of Tobacco Treatment: A Community-responsive Approach

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the proposed study is to determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, behavioral health treatment providers, and community members in Chicago and pilot test a community-informed, targeted rolling smoking cessation treatment within a community organization. The research team and the Respiratory Health Association (RHA) will work together to identify community sites that could derive possible benefit from adopting and implementing the targeted treatment.

Aim 1: Develop a Community Advisory Board (CAB) comprised of providers, community members, and organization leadership.

Aim 2: Use a mixed-methods approach to understand barriers, facilitators, and unmet treatment needs regarding smoking cessation treatment within the community.

Aim 3: Pilot test the targeted smoking cessation treatment across a 3-month period at one community site through partnership with Respiratory Health Association.

Hypothesis: The targeted intervention will demonstrate feasibility and acceptability.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilot Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session
Time Frame: 3 months
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
Time Frame: 3 months
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.
Time Frame: End of treatment (e.g., 3 months or fourth session attended, whichever comes first)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of cigarettes consumed per day
Time Frame: Through study completion, an average of 3 months
Participant self-report of past week average cigarettes smoked per day
Through study completion, an average of 3 months
Use of nicotine replacement therapy and FDA-approved cessation medication
Time Frame: Through study completion, an average of 3 months
Participant self-report of pharmacotherapy will be assessed at each session and end of treatment
Through study completion, an average of 3 months
Number of quit attempts
Time Frame: Through study completion, an average of 3 months
The number of times each participant has tried to quit, whether successful or not
Through study completion, an average of 3 months
Motivation to change smoking behavior via Contemplation Ladder
Time Frame: Through study completion, an average of 3 months
Participants' interest in quitting will be assessed on a 10-point quit interest scale (e.g., The Contemplation Ladder). Scores range from 0-10 with higher scores indicating greater motivation to change.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Respiratory Health Association

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 Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-2154
  • P50MD017349 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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