Development of a mHealth Intervention for Ambivalent Smokers

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2021-09-27

Brief Summary

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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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Detailed Description

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Conditions

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Tobacco Use Disorder Smoking Cessation Motivation Behavior, Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Control mHealth program

Intervention Type DEVICE

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

Nicotine patch

Intervention Type 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.

Experimental

Group Type EXPERIMENTAL

Experimental mHealth program

Intervention Type 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

Intervention Type 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.

Interventions

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Control mHealth program

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

Intervention Type DEVICE

Experimental mHealth program

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.

Intervention Type DEVICE

Nicotine patch

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes