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Completed

NCT Number: NCT04525222

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Promotion and Education

Other

Receive motivational messages and smoking cessation information via text notifications

Smoking Cessation Intervention (Actify app)

Behavioral

Use Actify app

Other names: Smoking and Tobacco Use Cessation Interventions

Smoking Cessation Intervention (Current Standard Care app)

Behavioral

Use (USCPG) Current Standard Care app

Other names: Smoking and Tobacco Use Cessation Interventions

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. Application (App) Utilization

    Time frame: At 8 weeks post-randomization

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

Secondary outcomes

  1. Biochemically-confirmed 30-day PPA From Smoking

    Time frame: At 8 weeks post-randomization

    Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO<6ppm)

  2. Self-reported 30-day PPA From Smoking

    Time frame: At 6 months post-randomization

    Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"

  3. Biochemically-confirmed 30-day PPA From Smoking

    Time frame: At 6 months post-randomization

    Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO<6 ppm)

  4. Self-reported 7-day PPA From Smoking

    Time frame: At 8 weeks post-randomization

    Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"

  5. Biochemically Confirmed 7-day PPA From Smoking

    Time frame: At 8 weeks post-randomization

    Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)

  6. Self-reported 7-day PPA From Smoking

    Time frame: At 6 months post-randomization

    Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"

  7. Biochemically Confirmed 7-day PPA From Smoking

    Time frame: At 6 months post-randomization

    Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)

  8. Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes

    Time frame: At 8 weeks post-randomization

    Self-reported 30-day abstinence on the survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"

  9. Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes

    Time frame: At 8 weeks post-randomization

    Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)

  10. Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes

    Time frame: At 6 months post-randomization

    Self-reported 30-day abstinence on survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"

  11. Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes

    Time frame: At 6 months post-randomization

    Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)

  12. Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)

    Time frame: Baseline to 8 weeks

    The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are "not at all" or "several days" or "more than half the days" or "nearly every day," with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

  13. Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking

    Time frame: At 8 weeks post-randomization

    Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"

  14. Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)

    Time frame: Baseline to 8 weeks post-randomization

    The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

An mHealth Mood Management Tool to Improve Population-Level Cessation

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 25, 2020
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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