Tobacco Use Disorder
Conditions
Keywords
Smoking cessation, Cue-based treatment, Cognitive Behavioral Therapy
Brief summary
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT)
CBT delivered via telehealth sessions and supportive text messages.
BEHAVIORALCue-based treatment intervention
Cue-based treatment includes exposure to smoking-related cues and coping strategies.
Sponsors
Duke University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Able to read and understand English or Spanish * Smoke 1-10 cigarettes/day on at least 4 days of the past two weeks for the last year * Willing to try quitting in next 30 days * Access to cell phone with texting capabilities
Exclusion criteria
* Current participation in another smoking cessation study * Unable to provide consent * Refusal to abstain from e-cigarettes or other tobacco products * Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by the number of participants who are recruited and randomized | 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 | End of treatment (up to 12 months) | — |
| Feasibility as measured by the number of participants who take pictures of smoking/craving situations | End of treatment (up to 12 months) | — |
| Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions | End of treatment (up to 12 months) | — |
| Feasibility as measured by the number of participants who complete all cue-based treatment sessions | End of treatment (up to 12 months) | — |
| Feasibility as measured by the number of participants who respond to EMA text based assessments | End of treatment (up to 12 months) | — |
| Feasibility as measured by the number of participants who proactively text to report cravings | End of treatment (up to 12 months) | — |
| Acceptability of CBT + cue-based treatment intervention compared to CBT only | End of treatment (up to 12 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting the presence of smoking cues | 7 days after end of each CBT session (4 sessions total) | The brief EMA text-based assessment will include a question to assess the presence of smoking cues. |
| Craving level | 7 days after end of each CBT session (4 sessions total) | 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?" |
| Stress level | 7 days after end of each CBT session (4 sessions total) | 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?" |
| Current mood | 7 days after end of each CBT session (4 sessions total) | 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?" |
| Number of participants who reported 30-day point prevalence abstinence | End of Treatment, 6 months | Smoking cessation will be assessed using self-reported 30-day point prevalence abstinence (e.g., smoked any cigarettes in the past 30 days?). |
| Smoking status as measured by salivary cotinine | End of Treatment, 6 months | Smoking status will be biochemically validated via salivary cotinine levels. |
Countries
United States
Contacts
CONTACTLaura Fish, PhD
CONTACTLauren Hart, MSW, MPH
PRINCIPAL_INVESTIGATORLaura Fish
Duke University
Outcome results
None listed