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Completed

NCT Number: NCT04560868

Development of a mHealth Intervention for Ambivalent Smokers

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.

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Key information

Conditions

Tobacco Use Disorder Behavior Behavior, Smoking Chemically-Induced Disorders Health Behavior Mental Disorders Motivation Smoking Smoking Cessation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years or older;
  • Can speak/read English;
  • Current smoker;
  • Own and regularly use an eligible smartphone;
  • No vision impairments;
  • Willing to install and use the study program;
  • Willing to use birth control if elect to use nicotine replacement during the study (females);
  • Meet definition for ambivalence
  • Not actively using treatment

Exclusion criteria

  • Smoke less than 10 cigarettes per day
  • Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
  • Have medical contraindications for nicotine replacement therapy;
  • Another household member is enrolled in the study
  • Unable to verify contact information
  • Fail to install app

Treatment and study plan

Control mHealth program

Device

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.

Experimental mHealth program

Device

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.

Nicotine patch

Drug

Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.

Primary outcomes

  1. Program Engagement

    Time frame: Assessed at 3-month follow-up

    Number of unique app user-sessions

  2. Quit Attempt Lasting at Least 24 Hours

    Time frame: Assessed at 3-month follow-up

    At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.

  3. Not Smoking (Even a Puff) in the Last 7 Days

    Time frame: Assessed at 3-month follow-up

    7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.

Secondary outcomes

  1. Satisfaction With Assigned App

    Time frame: Assessed at 1 month

    Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".

  2. Satisfaction With Assigned App

    Time frame: Assessed at 3 months

    Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".

  3. Helpfulness of Assigned App

    Time frame: Assessed at 1 month.

    Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".

  4. Helpfulness of Assigned App

    Time frame: Assessed at 3 months

    Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".

  5. Program Engagement - Earned Badges

    Time frame: Assessed at 1-month follow-up

    Number of accumulated badge rewards earned from using the assigned app.

  6. Program Engagement - Earned Badges

    Time frame: Assessed at 3-month follow-up

    Number of accumulated badge rewards earned from using the assigned app.

  7. Self-efficacy to Quit Smoking

    Time frame: Assessed at 1 month

    Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".

  8. Self-efficacy to Quit Smoking

    Time frame: Assessed at 3 months

    Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".

  9. Self-efficacy to Stay Quit

    Time frame: Assessed at 1 month

    Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".

  10. Self-efficacy to Stay Quit

    Time frame: Assessed at 3 months

    Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".

  11. Earned and Requested Free Nicotine Replacement Therapy

    Time frame: Assessed at 1-month follow-up

    Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.

  12. Earned and Requested Free Nicotine Replacement Therapy

    Time frame: Assessed at 3-month follow-up

    Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.

  13. Quit Attempt Lasting at Least 24 Hours

    Time frame: Assessed at 1 month follow-up

    At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.

  14. Change in Cigarettes/Day

    Time frame: Assessed at baseline and 1 month

    Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.

  15. Change in Cigarettes/Day

    Time frame: Assessed at baseline and 3 months

    Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.

  16. Refrain From Smoking (Even a Puff) in the Last 7 Days

    Time frame: Assessed at 1-month follow-up

    7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2020
Registry last updated
Jan 23, 2023

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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