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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 1

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Other: Survey Administration; Behavioral: Smoking Cessation Intervention (Current Standard Care app); Behavioral: Smoking Cessation Intervention (Actify app); Other: Health Promotion and Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04525222

NCI-2020-05454 (Registry Identifier)

RG1121054

10540 (Registry Identifier)

R34DA050967 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups

Arm I (Actify, text notifications)

Experimental group

Description:

Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.

Treatment:

Other: Survey Administration

Other: Health Promotion and Education

Behavioral: Smoking Cessation Intervention (Actify app)

Arm II (Current Standard Care, text notifications)

Active Comparator group

Description:

Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.

Treatment:

Other: Survey Administration

Other: Health Promotion and Education

Behavioral: Smoking Cessation Intervention (Current Standard Care app)