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Recruiting NCT06837220

Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

No phase Interventional Nicotine Use Disorder Smoking Cessation Smoking Cessation Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Courage to Quit.
Who it may be relevant to
Registry conditions: Nicotine Use Disorder, Smoking Cessation, Smoking Cessation Intervention. Basic parameters: 18 years — 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session [Time frame: 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]
  • 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)]
Secondary outcome measures (4)
  • Change in number of cigarettes consumed per day [Time frame: 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]
  • Number of quit attempts [Time frame: 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Chicago — Chicago

Identifiers

NCT: NCT06837220 · IRB24-2154 · P50MD017349

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗