Cigarette Smoking, Depression, Smoking Cessation
Conditions
Brief summary
The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app (Goal2Quit) packaged with nicotine replacement therapy (NRT) sampling. This integrated intervention will address the need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.
Interventions
BEHAVIORALTreatment as Usual
Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
COMBINATION_PRODUCTGoal2Quit + NRT Sampling
Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week starter kit sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
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
* Current elevated depressive symptoms defined as a score of \> 10 (at least mild depression) on the Patient Health Questionnaire-8 (PHQ-8) * Current smoking, defined as smoking 10+ cigarettes/day, for 25+ days out of the last 30, for the last 6+ months * Ownership of an Android or iOS smartphone * Age 18+ * Possess a valid e-mail address that is checked daily to access follow-up assessments * English fluency
Exclusion criteria
\- Contraindications for NRT (pregnancy/intention to become pregnant/breastfeeding, recent cardiovascular trauma/uncontrolled hypertension) - Severe visual impairment, which may limit ability to utilize an app
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Point Prevalence Abstinence | From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment. | Patients will self report smoking status (yes/no) for the seven days preceding the 12-week follow-up assessment. The data reported is based on the participants that reported yes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Depressive Symptoms | Change in BDI from baseline to Week 12 | Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment As Usual Treatment as Usual: Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. | 47 |
| Goal2Quit + NRT Sampling Goal2Quit + NRT Sampling: Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week starter kit sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. | 103 |
| Total | 150 |
Baseline characteristics
| Characteristic | Goal2Quit + NRT Sampling | Total | Treatment As Usual |
|---|---|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 9.7 | 38.4 years STANDARD_DEVIATION 10.3 | 41.2 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 13 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 137 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 33 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 17 Participants | 9 Participants |
| Race (NIH/OMB) White | 74 Participants | 100 Participants | 26 Participants |
| Sex: Female, Male Female | 53 Participants | 80 Participants | 27 Participants |
| Sex: Female, Male Male | 50 Participants | 70 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 103 |
| other Total, other adverse events | 0 / 47 | 0 / 103 |
| serious Total, serious adverse events | 0 / 47 | 0 / 103 |
Outcome results
Primary
7 Day Point Prevalence Abstinence
Patients will self report smoking status (yes/no) for the seven days preceding the 12-week follow-up assessment. The data reported is based on the participants that reported yes.
Time frame: From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment As Usual | 7 Day Point Prevalence Abstinence | 1 Participants |
| Goal2Quit + NRT Sampling | 7 Day Point Prevalence Abstinence | 16 Participants |
Secondary
Mean Score of Depressive Symptoms
Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.
Time frame: Change in BDI from baseline to Week 12
Population: The overall number of participants analyzed is inconsistent because this is the number of participants that completed their week 12 surveys in order to be included in this particular data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual | Mean Score of Depressive Symptoms | -6.97 score on a scale | Standard Deviation 11.15 |
| Goal2Quit + NRT Sampling | Mean Score of Depressive Symptoms | -9.06 score on a scale | Standard Deviation 11.6 |