Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

University of Massachusetts, Worcester

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: NRT and mHealth assessment tool without feedback; Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02973425

R25CA172009-01A1 (U.S. NIH Grant/Contract)

H00007427

R01CA190866-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..

Full description

The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are

• AIM 1: Refine the Take a Break mHealth tool and implementation program.
• AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.
• AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.

Exclusion criteria

• Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.

Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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433 participants in 2 patient groups

NRT and mHealth assessment tool without feedback

Active Comparator group

Description:

For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback.

Treatment:

Behavioral: NRT and mHealth assessment tool without feedback

Take a Break as an augmentation to NRT in Motivation

Experimental group

Description:

The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite.

Treatment:

Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase