This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 months, and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CBT delivered via telehealth sessions and supportive text messages.
Cue-based treatment includes exposure to smoking-related cues and coping strategies.
Feasibility as measured by the number of participants who are recruited and randomized
Time frame: During the recruitment period (up to 9 months)
Feasibility as measured by the number of participants who respond to pre-quit real-time data collection
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings
Time frame: End of treatment (up to 12 months)
Acceptability of CBT + cue-based treatment intervention compared to CBT only
We will assess acceptability quantitatively and qualitatively. We will assess message helpfulness (1=Not at all helpful to 5=extremely helpful) and whether participants would recommend the program to a friend (1=definitely would not recommend to 5=definitely would recommend). We will also assess participant fidelity to the intervention protocol (e.g., experienced cues and texted to report when experiencing a cue). Qualitative data will be used to describe barriers and facilitators to intervention uptake among participants in the CBT + cue-based treatment arm.
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Time frame: End of treatment (up to 12 months)
Number of participants reporting the presence of smoking cues
The brief EMA text-based assessment will include a question to assess the presence of smoking cues.
Time frame: 7 days after end of each CBT session (4 sessions total)
Craving level
The brief EMA text-based assessment will include a question to assess current craving level: "How strong was your craving on a scale from 1=None to 10=Very Strong?"
Time frame: 7 days after end of each CBT session (4 sessions total)
Stress level
The brief EMA text-based assessment will include a question to assess current stress level: "How stressed did you feel on a scale from not at all stressed=1 to extremely stressed=10?"
Time frame: 7 days after end of each CBT session (4 sessions total)
Current mood
The brief EMA text-based assessment will include a question to assess current mood: "How is your mood right now 1=Extremely bad to 10=Extremely good?"
Time frame: 7 days after end of each CBT session (4 sessions total)
Number of participants who reported 30-day point prevalence abstinence
Smoking cessation will be assessed using self-reported 30-day point prevalence abstinence (e.g., smoked any cigarettes in the past 30 days?).
Time frame: End of Treatment, 6 months
Smoking status as measured by salivary cotinine
Smoking status will be biochemically validated via salivary cotinine levels.
Time frame: End of Treatment, 6 months