Phase 1
Completed N=63
Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Source: ClinicalTrials.gov NCT03069482 ↗Enrolled (actual)
63
Serious AEs
16.1%
Results posted
Mar 2020
Primary outcomePrimary: Days of App Use — 34.1; 32 days — p==0.754
Summary
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.
Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.
However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?
Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of App Use |
34.1; 32 | =0.754 |
| PRIMARY Duration of App Use |
4.24; 2.14 | 0.044 sig |
| PRIMARY Feasibility as Measured by Study Accrual Relative to Recruitment Goal |
102 | — |
| PRIMARY Feasibility as Measured by Study Attrition |
33; 28 | — |
| PRIMARY Recruitment Yield Effort |
290 | — |
| PRIMARY Feasibility of Measurement Strategy |
1353; 1284 | — |
| PRIMARY Usability of App Design as Measured by the System Usability Scale (SUS) |
85.2; 78.7 | 0.27411 |
| PRIMARY Usability of App Design as Measured by the System Usability Scale (SUS) |
85.2; 78.7 | 0.27411 |
| PRIMARY Usability of App Design as Measured by the System Usability Scale (SUS) |
85.2; 78.7 | 0.27411 |
| PRIMARY Usability of App Design as Measured by the System Usability Scale (SUS) |
85.2; 78.7 | 0.27411 |
| SECONDARY Biochemically Confirmed 7-day Point Prevalence Abstinence |
4; 1 | — |
| SECONDARY Biochemically Confirmed 7-day Point Prevalence Abstinence |
4; 1 | — |
| SECONDARY Biochemically Confirmed 7-day Point Prevalence Abstinence |
4; 1 | — |
| SECONDARY Biochemically Confirmed 7-day Point Prevalence Abstinence |
4; 1 | — |
| SECONDARY Biochemically Confirmed Prolonged Abstinence Rates |
0; 0 | — |
| SECONDARY Biochemically Confirmed Prolonged Abstinence Rates |
0; 0 | — |
| SECONDARY Biochemically Confirmed Prolonged Abstinence Rates |
0; 0 | — |
| SECONDARY Biochemically Confirmed Prolonged Abstinence Rates |
0; 0 | — |
| SECONDARY 30-day Point Prevalence Abstinence Rates |
4; 3 | — |
| SECONDARY 30-day Point Prevalence Abstinence Rates |
4; 3 | — |
| SECONDARY 30-day Prevalence Abstinence Rates |
1; 3 | — |
| SECONDARY 30-day Point Prevalence Abstinence Rates |
4; 3 | — |
| SECONDARY 7-day Point Prevalence Abstinence |
4; 3 | — |
| SECONDARY 7-day Point Prevalence Abstinence |
4; 3 | — |
| SECONDARY 7-day Point Prevalence Abstinence |
4; 3 | — |
| SECONDARY 7-day Point Prevalence Abstinence |
4; 3 | — |
| SECONDARY 24-hour Point Prevalence Abstinence |
7; 7 | — |
| SECONDARY 24-hour Point Prevalence Abstinence |
7; 7 | — |
| SECONDARY 24-hour Point Prevalence Abstinence |
7; 7 | — |
| SECONDARY 24-hour Point Prevalence Abstinence |
7; 7 | — |
| SECONDARY Average Number of Quit Attempts Per Arm |
1.61; 1.96 | — |
| SECONDARY Average Number of Quit Attempts Per Arm |
1.61; 1.96 | — |
| SECONDARY Average Number of Quit Attempts Per Arm |
1.61; 1.96 | — |
| SECONDARY Average Number of Quit Attempts Per Arm |
1.61; 1.96 | — |
| SECONDARY Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence |
0.81; 1.88; 1; 1.47; 1.29; 1.74 | — |
| SECONDARY Change in Average Number of Cigarettes Smoked Per Day |
10.0; 5.2; 11.3; 7.5; 11.5; 6.0 | — |
| SECONDARY Nicotine Replacement Patch Utilization |
3.4; 5.3 | — |
| SECONDARY Nicotine Replacement Patch Utilization |
3.4; 5.3 | — |
| SECONDARY Nicotine Replacement Patch Utilization |
3.4; 5.3 | — |
| SECONDARY Nicotine Replacement Patch Utilization |
3.4; 5.3 | — |
| SECONDARY Nicotine Replacement Lozenge Utilization |
2.3; 1.3 | — |
| SECONDARY Nicotine Replacement Lozenge Utilization |
2.3; 1.3 | — |
| SECONDARY Nicotine Replacement Lozenge Utilization |
2.3; 1.3 | — |
| SECONDARY Nicotine Replacement Lozenge Utilization |
2.3; 1.3 | — |
| SECONDARY Affect Ratings - Learn to Quit |
5.4666165 | — |
| SECONDARY Affect Ratings - QuitGuide |
52.26; 43.90; 3.83 | — |
| SECONDARY Smoking Cravings |
6.13; 4.55 | — |
| SECONDARY Psychotic Symptoms |
11.63; 11.55; 12.16; 12.23 | — |
| SECONDARY Psychotic Symptoms |
11.63; 11.55; 12.16; 12.23 | — |
| SECONDARY Psychotic Symptoms |
11.63; 11.55; 12.16; 12.23 | — |
| SECONDARY Psychotic Symptoms |
11.63; 11.55; 12.16; 12.23 | — |
| SECONDARY General Psychiatric Symptoms |
0.94; 0.90 | — |
| SECONDARY General Psychiatric Symptoms |
0.94; 0.90 | — |
| SECONDARY General Psychiatric Symptoms |
0.94; 0.90 | — |
| SECONDARY General Psychiatric Symptoms |
0.94; 0.90 | — |
Eligibility Criteria
Inclusion Criteria
- ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder
- Smoking ≥ 5 cigarettes per day over the past 30 days
- Desire to quit smoking in the next 30 days
- Willing and medically eligible to use Nicotine Replacement Therapy
- Fluent in spoken and written English
- Working email, mailing address, or alternative contact person
- Taking psychiatric medications as prescribed by their provider
- Stable housing
Exclusion Criteria
- Problematic alcohol or illicit drug use in the last 30 days
- Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable
- Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months
- Hearing, comprehension, or visual limitations that preclude study participation
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
- Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. e-cigarettes, chew)
Data sourced from ClinicalTrials.gov (NCT03069482). 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.