Clinical trial NCT05836103: Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
Official title: Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Cigarette Smoking
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose to test tailored smartphone-based messages to support young adults in quitting smoking. This study addresses 3 specific aims.

For Aim 1, a micro-randomized trial (within-subject randomization) with 80 young adult smokers will investigate the efficacy of smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.

In Aim 2, a built-in and conventionally randomized EMA-only control group will allow us to test if intervention messages result in changes in smoking behavior over time. The primary outcome will be self-reported number of cigarettes per day at end of treatment, as well as 3- and 6-month follow-up.

Aim 3 will explore moderation effects of substance co-use (cannabis, alcohol, other drugs) and exposure to specific locations (home, work, bars) on urge reduction message efficacy among intervention group participants.
Primary purpose: TREATMENT

Brief summary: Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and Commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for young adults targeted at specific high-risk situations for smoking.

Detailed description: This research will address the following specific aims:

Aim 1: To test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=80). To inform just-in-time interventions, it is crucial to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The investigators will conduct a micro-randomized trial (repeated within-subject randomizations of messages) to accomplish this. In line with the investigators' existing protocol, participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing the investigators to determine high-risk situations for smoking. In the following intervention phase, participants receive tailored messages triggered by geofencing of participants' high-risk locations for a total of 30 days. Tailoring is based on established predictors of smoking relapse (stress and presence of other smokers). The micro-randomized trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other tobacco use (including e-cigarettes), affect, and stress.

Aim 2: To test if exposure to urge reduction messages results in changes in smoking behavior over time compared to an EMA only control group (N=80). It is important to investigate if repeated messages in the micro-randomized trial impact smoking behavior over time, in contrast to just repeated assessment without messages. Thus, this study includes a conventionally randomized clinical-trial component. Parallel to the micro-randomized trial group, a control group completes EMA surveys only without intervention messages. This allows the investigators to test if messages reduce smoking behavior. The primary outcome is number of cigarettes per day at end of treatment, 3-, and 6-months follow-up. Secondary analyses explore biochemically verified 7-day point prevalence abstinence, switching to e-cigarettes, and other tobacco outcomes. Post-hoc dose-response analyses investigate the long-term efficacy of CBT or Mindfulness/ACT messages on smoking behavior.

Aim 3: Explore moderation effects of substance co-use (cannabis, alcohol, other drugs) and exposure to specific location (home, work, bars) on urge reduction message efficacy. A crucial research question to inform future mobile interventions is how well intervention messages work in different situational contexts and when people are co-using other substances. Among intervention group participants, the investigators will explore how urge reduction message efficacy may be moderated by substance co-use and exposure to specific settings.

Eligibility criteria: Inclusion Criteria:

1. live in the U.S.
2. read English;
3. are between 18 and 30 years of age;
4. own an iPhone or Android smartphone;
5. have smoked ≥100 cigarettes in their lives and currently smoke at least 3 cigarettes per day on 5 or more days of the week;
6. are planning to quit smoking within the next 30 days.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in smoking urge as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Change in cigarettes smoked per day in past week as assessed by a single item
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
Secondary outcomes:
measure: Smoking since intervention message delivery as assessed by a single item
timeFrame: 15 minutes after message deliery
measure: Other tobacco product use since intervention message delivery as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Change in stress as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Change in negative affect as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Message helpfulness as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Activity completion as assessed by a single item
timeFrame: 15 minutes after message delivery
measure: Self-reported 7-day point prevalence abstinence as assessed by a single item
timeFrame: 45-day follow-up
measure: Self-reported 7-day point prevalence abstinence as assessed by a single item
timeFrame: 3-month follow-up
measure: Self-reported 7-day point prevalence abstinence as assessed by a single item
timeFrame: 6-month follow-up
measure: Saliva-cotinine confirmed 7-day point prevalence abstinence
timeFrame: 45-day follow-up
measure: Saliva-cotinine confirmed 7-day point prevalence abstinence
timeFrame: 3-month follow-up
measure: Saliva-cotinine confirmed 7-day point prevalence abstinence
timeFrame: 6-month follow-up
measure: Change in cigarettes smoked as assessed by a single item
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
measure: Tobacco quit attempt as a assessed by a single item
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
measure: Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
measure: Change in psychological flexibility as assessed by the CompACT-15
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
measure: Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
measure: Tobacco product switching as assessed by 5 questions
timeFrame: Baseline, 45-day, 3-month, and 6-month follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Johannes Thrul, PhD
role: PRINCIPAL_INVESTIGATOR
References: