mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation

Study Overview
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Brief Summary
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This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text messages to help with quitting smoking and improved mood.

Detailed Description
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OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text messages. ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text messages. After completion of study, participants are followed up at 6 months.

Official Title
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An mHealth Mood Management Tool to Improve Population-Level Cessation

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Other: Health Promotion and Education
* Behavioral: Smoking Cessation Intervention (Actify app)
* Behavioral: Smoking Cessation Intervention (Current Standard Care app)
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current smoker, averaging at least 5 cigarettes/day for the last 30 days Interested in quitting smoking in the next 30 days Experience downloading and using one or more apps on their smartphone Either screens negative (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression (n = 120) or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19; n = 120) Willing and able to complete all study activities Comfortable reading and writing in English Exclusion Criteria: Currently receiving behavioral treatment for depression (e.g., psychotherapy) Current use of a depression app Severe depression (PHQ-9 >= 20) Current suicidal ideation (PHQ-9 item 9 score > 1) Receiving other treatment for smoking cessation Previous use of the USCPG app Employees/family of investigator or study center Member of the same household as another participant Woman who is pregnant or breastfeeding, or planning to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (Actify, text messages)<br>Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text messages. | Other: Health Promotion and Education<br>* Receive motivational messages and smoking cessation information via text messages<br>Behavioral: Smoking Cessation Intervention (Actify app)<br>* Use Actify app<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (Current Standard Care, text messages)<br>Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text messages. | Other: Health Promotion and Education<br>* Receive motivational messages and smoking cessation information via text messages<br>Behavioral: Smoking Cessation Intervention (Current Standard Care app)<br>* Use (USCPG) Current Standard Care app<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with assigned treatment on the Treatment Satisfaction Survey | Satisfaction will be assessed with 8 items covering both overall satisfaction and satisfaction with specific app components. The satisfaction survey contains forced-choice response items assessing overall satisfaction, whether participants would recommend the program to a friend, and satisfaction with the program's content, organization, and ease of use. Open-ended questions will inquire about what participants liked most and least about their assigned intervention | At 8 weeks post-randomization | 
| Application (app) utilization | Total number of server-recorded openings of the assigned intervention | At 8 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day point prevalence abstinence (PPA) from smoking |  | At 8 weeks post-randomization | 
| Self-reported 30-day PPA from smoking |  | At 6 months post-randomization | 
| Biochemically-confirmed 30-day PPA from smoking |  | At 8 weeks post-randomization | 
| Biochemically-confirmed 30-day PPA from smoking |  | At 6 months post-randomization | 
| Self-reported 7-day PPA from smoking |  | At 8 weeks post-randomization | 
| Biochemically confirmed 7-day PPA from smoking |  | At 8 weeks post-randomization | 
| Self-reported 7-day PPA from smoking |  | At 6 months post-randomization | 
| Biochemically confirmed 7-day PPA from smoking |  | At 6 months post-randomization | 
| Self-reported 30-day PPA from smoking cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes |  | At 8 weeks post-randomization | 
| Biochemically confirmed 30-day PPA from smoking cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes |  | At 8 weeks post-randomization | 
| Self-reported 30-day PPA from smoking cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes |  | At 6 months post-randomization | 
| Biochemically confirmed 30-day PPA from smoking cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes |  | At 6 months post-randomization | 
| Change in behavioral activation assessed via Behavioral Activation for Depression Scale (BADS) | The BADS is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavior activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment. | Baseline to 8 weeks post-randomization | 
| Change in depressive symptoms via Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The scale scores range from 1 to 27, with severity thresholds as follows: 5-9=mild, 10-14=moderate, 15-19=moderately severe, 20-27=severe. | Baseline to 8 weeks post-randomization |