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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34CA304591 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| University of Oklahoma | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT only | Active Comparator | CBT delivered via telehealth sessions and supportive text messages. |
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| CBT + Cue-based treatment | Experimental | CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | CBT delivered via telehealth sessions and supportive text messages. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days after end of each CBT session (4 sessions total) |
| Craving level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Fish, PhD | Contact | 919-681-3820 | laura.fish@duke.edu | |
| Lauren Hart, MSW, MPH | Contact | 919-613-2607 | lauren.j.hart@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura Fish | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cue-based treatment intervention | Behavioral | Cue-based treatment includes exposure to smoking-related cues and coping strategies. |
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| End of treatment (up to 12 months) |
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?"
| 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?" | 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?" | 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?). | End of Treatment, 6 months |
| Smoking status as measured by salivary cotinine | Smoking status will be biochemically validated via salivary cotinine levels. | End of Treatment, 6 months |
| D001519 | Behavior |