Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

Not Applicable

Not yet recruiting

• Conditions: Nicotine Use Disorder; Smoking Cessation; Smoking Cessation Intervention

• Registration Number: NCT06837220
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session	3 months	We will consider the initial pilot period of the enhanced intervention successful if we enroll (attend one session) and retain (attend four or more sessions) in the pilot treatment across three 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	3 months	We will consider the intervention design to be feasible if fewer than 40% of enrollees drop out after their first attended session.
A modified version of the Client Satisfaction Questionnaire (CSQ) will assess intervention acceptability.	End of treatement (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, we predict at least 75% of participants will rate the intervention as acceptable via post-treatment survey (CSQ).

Secondary Outcome Measures

Name	Time	Method
Change in number of cigarettes consumed per day	Through study completion, an average of 3 months	Participant self-report of past week average cigarettes smoked per day
Use of nicotine replacement therapy and FDA-approved cessation medication	Through study completion, an average of 3 months	Participant self-report of pharmacotherapy will be assessed at each session and end of treatment
Number of quit attempts	Through study completion, an average of 3 months	The number of times each participant has tried to quit, whether successful or not
Motivation to change smoking behavior via Contemplation Ladder	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.