An mHealth Mood Management Tool to Improve Population-Level Cessation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cigarette Smoking-Related Carcinoma
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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 notifications to help with quitting smoking and improved mood.
Detailed Description
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 notifications. 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 notifications. After completion of study, participants are followed up at 6 months.
Investigators
Jaimee Heffner
Associate Professor
Fred Hutchinson Cancer Center
Eligibility Criteria
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 or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
- •Willing and able to complete all study activities
- •Comfortable reading and writing in English
- •Have a mobile data plan and/or access to WiFi to support the use of the Actify app
- •Reside in the US
- •Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)
Exclusion Criteria
- •Currently receiving behavioral treatment for depression (e.g., psychotherapy)
- •Current use of a depression app
- •Severe depression (PHQ-9 \>= 20)
- •Receiving other treatment for smoking cessation
- •Previous use of the QuitGuide app
- •Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
- •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
- •Currently incarcerated
Outcomes
Primary Outcomes
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
Time Frame: At 8 weeks post-randomization
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.
Application (App) Utilization
Time Frame: At 8 weeks post-randomization
Number of app openings during the 8-week treatment period.
Secondary Outcomes
- Biochemically-confirmed 30-day PPA From Smoking(At 6 months post-randomization)
- Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)(Baseline to 8 weeks post-randomization)
- Biochemically Confirmed 7-day PPA From Smoking(At 6 months post-randomization)
- Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)(Baseline to 8 weeks)
- 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)
- Self-reported 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 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)