Clinical trial NCT04525222: mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation
Official title: An mHealth Mood Management Tool to Improve Population-Level Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-25
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Is ineligible per fraud prevention protocol

Primary outcomes:
measure: Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
timeFrame: At 8 weeks post-randomization
measure: Application (App) Utilization
timeFrame: At 8 weeks post-randomization
Secondary outcomes:
measure: Biochemically-confirmed 30-day PPA From Smoking
timeFrame: At 8 weeks post-randomization
measure: Self-reported 30-day PPA From Smoking
timeFrame: At 6 months post-randomization
measure: Biochemically-confirmed 30-day PPA From Smoking
timeFrame: At 6 months post-randomization
measure: Self-reported 7-day PPA From Smoking
timeFrame: At 8 weeks post-randomization
measure: Biochemically Confirmed 7-day PPA From Smoking
timeFrame: At 8 weeks post-randomization
measure: Self-reported 7-day PPA From Smoking
timeFrame: At 6 months post-randomization
measure: Biochemically Confirmed 7-day PPA From Smoking
timeFrame: At 6 months post-randomization
measure: Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
timeFrame: At 8 weeks post-randomization
measure: Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
timeFrame: At 8 weeks post-randomization
measure: Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
timeFrame: At 6 months post-randomization
measure: Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
timeFrame: At 6 months post-randomization
measure: Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline to 8 weeks
measure: Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking
timeFrame: At 8 weeks post-randomization
measure: Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)
timeFrame: Baseline to 8 weeks post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner
role: PRINCIPAL_INVESTIGATOR
References: