Phase 1
Completed N=57
Development of a mHealth Intervention for Ambivalent Smokers
Tobacco Use · Smoking Cessation · Motivation · Behavior, Smoking
Source: ClinicalTrials.gov NCT04560868 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Program Engagement — 7.3; 19.9 User sessions — p=<0.01
Summary
The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Engagement |
7.3; 19.9 | <0.01 sig |
| PRIMARY Quit Attempt Lasting at Least 24 Hours |
6; 6 | 0.99 |
| PRIMARY Not Smoking (Even a Puff) in the Last 7 Days |
2; 4 | 0.35 |
| SECONDARY Satisfaction With Assigned App |
4.0; 4.0 | 0.90 |
| SECONDARY Satisfaction With Assigned App |
4.0; 4.0 | 0.90 |
| SECONDARY Helpfulness of Assigned App |
3.1; 3.6 | 0.11 |
| SECONDARY Helpfulness of Assigned App |
3.1; 3.6 | 0.11 |
| SECONDARY Program Engagement - Earned Badges |
6.1; 10.1 | <0.01 sig |
| SECONDARY Program Engagement - Earned Badges |
6.1; 10.1 | <0.01 sig |
| SECONDARY Self-efficacy to Quit Smoking |
7.9; 6.8 | 0.31 |
| SECONDARY Self-efficacy to Quit Smoking |
7.9; 6.8 | 0.31 |
| SECONDARY Self-efficacy to Stay Quit |
10; 9 | — |
| SECONDARY Self-efficacy to Stay Quit |
10; 9 | — |
| SECONDARY Earned and Requested Free Nicotine Replacement Therapy |
2; 8 | 0.06 |
| SECONDARY Earned and Requested Free Nicotine Replacement Therapy |
2; 8 | 0.06 |
| SECONDARY Quit Attempt Lasting at Least 24 Hours |
6; 6 | 0.99 |
| SECONDARY Change in Cigarettes/Day |
17.6; 17.9; -6.7; -5.2 | 0.47 |
| SECONDARY Change in Cigarettes/Day |
17.6; 17.9; -6.7; -5.2 | 0.47 |
| SECONDARY Refrain From Smoking (Even a Puff) in the Last 7 Days |
0; 1 | 0.30 |
Eligibility Criteria
Inclusion Criteria
- 18 years or older;
- Can speak/read English;
- Current smoker;
- Own and regularly use an eligible smartphone;
- No vision impairments;
- Willing to install and use the study program;
- Willing to use birth control if elect to use nicotine replacement during the study (females);
- Meet definition for ambivalence
- Not actively using treatment
Exclusion Criteria
- Smoke less than 10 cigarettes per day
- Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
- Have medical contraindications for nicotine replacement therapy;
- Another household member is enrolled in the study
- Unable to verify contact information
- Fail to install app
Data sourced from ClinicalTrials.gov (NCT04560868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.