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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2023-04-12

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 notifications to help with quitting smoking and improved mood.

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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 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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Any outcome evaluator who has direct contact with participants will be blinded to treatment group assignment

Study Groups

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Arm I (Actify, text notifications)

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

Group Type EXPERIMENTAL

Health Promotion and Education

Intervention Type OTHER

Receive motivational messages and smoking cessation information via text notifications

Smoking Cessation Intervention (Actify app)

Intervention Type BEHAVIORAL

Use Actify app

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (Current Standard Care, text notifications)

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

Group Type ACTIVE_COMPARATOR

Health Promotion and Education

Intervention Type OTHER

Receive motivational messages and smoking cessation information via text notifications

Smoking Cessation Intervention (Current Standard Care app)

Intervention Type BEHAVIORAL

Use (USCPG) Current Standard Care app

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Health Promotion and Education

Receive motivational messages and smoking cessation information via text notifications

Intervention Type OTHER

Smoking Cessation Intervention (Actify app)

Use Actify app

Intervention Type BEHAVIORAL

Smoking Cessation Intervention (Current Standard Care app)

Use (USCPG) Current Standard Care app

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Smoking and Tobacco Use Cessation Interventions Smoking and Tobacco Use Cessation Interventions

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes