Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

live in the U.S.

read English;

are between 18 and 30 years of age;

own an iPhone or Android smartphone;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone-based intervention messages

    Behavioral

    Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Micro-randomized trial groupExperimental treatment 1 intervention
Group B: EMA-only control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in smoking urge as assessed by a single item

The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Urge will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

Time frame
15 minutes after message delivery
2

Change in cigarettes smoked per day in past week as assessed by a single item

The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-day, 3-month, and 6-month follow-up.

Time frame
Baseline, 45-day, 3-month, and 6-month follow-up

Secondary outcomes

1

Smoking since intervention message delivery as assessed by a single item

Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

Time frame
15 minutes after message deliery
2

Other tobacco product use since intervention message delivery as assessed by a single item

Other tobacco product use, including e-cigarette use, in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

Time frame
15 minutes after message delivery
3

Change in stress as assessed by a single item

Change in rating of stress in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Stress will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

Time frame
15 minutes after message delivery
4

Change in negative affect as assessed by a single item

Change in rating of negative affect in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Negative affect will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

Time frame
15 minutes after message delivery

Other outcomes

Sponsors and contacts

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