Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Enhanced Courage to Quit
BehavioralParticipants 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Pilot InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
3 months2
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.
Time frame
3 months3
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).
Time frame
End of treatment (e.g., 3 months or fourth session attended, whichever comes first)Secondary outcomes
1
Change in number of cigarettes consumed per day
Participant self-report of past week average cigarettes smoked per day
Time frame
Through study completion, an average of 3 months2
Use of nicotine replacement therapy and FDA-approved cessation medication
Participant self-report of pharmacotherapy will be assessed at each session and end of treatment
Time frame
Through study completion, an average of 3 months3
Number of quit attempts
The number of times each participant has tried to quit, whether successful or not
Time frame
Through study completion, an average of 3 months4
Motivation to change smoking behavior via Contemplation Ladder
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.
Time frame
Through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
Respiratory Health Association
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov