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

NCT04525222 | Completed Phase 1 Results

• 4 other identifiers: RG1121054NCI-2020-0545410540R34DA050967
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (2)

• Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey

  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.

  At 8 weeks post-randomization

• Application (App) Utilization

  Number of app openings during the 8-week treatment period.

  At 8 weeks post-randomization

Secondary Outcomes (14)

• Biochemically-confirmed 30-day 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 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

Study Arms (2)

Arm I (Actify, text notifications)

EXPERIMENTAL

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

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

Arm II (Current Standard Care, text notifications)

ACTIVE COMPARATOR

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

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

Interventions

Health Promotion and Education OTHER

Receive motivational messages and smoking cessation information via text notifications

Arm I (Actify, text notifications); Arm II (Current Standard Care, text notifications)

Smoking Cessation Intervention (Actify app) BEHAVIORAL

Use Actify app

Also known as: Smoking and Tobacco Use Cessation Interventions

Arm I (Actify, text notifications)

Smoking Cessation Intervention (Current Standard Care app) BEHAVIORAL

Use (USCPG) Current Standard Care app

Also known as: Smoking and Tobacco Use Cessation Interventions

Arm II (Current Standard Care, text notifications)

Survey Administration OTHER

Ancillary studies

Arm I (Actify, text notifications); Arm II (Current Standard Care, text notifications)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Health Promotion; Educational Status; Smoking Devices

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jaimee Heffner, Ph.D., Associate Professor
• Organization: Fred Hutchinson Cancer Center

jheffner@fredhutch.org

206.667.7314

Study Officials

• Jaimee Heffner

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Any outcome evaluator who has direct contact with participants will be blinded to treatment group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 25, 2020
• Study Start: May 9, 2022
• Primary Completion: December 19, 2022
• Study Completion: April 12, 2023
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)