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Behavioural Intervention

Smartphone Messaging Support for Smoking

N/A

Recruiting

Led By Johannes Thrul, PhD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the efficacy of CBT and mindfulness/ACT interventions to help young adults quit smoking in real-time.

Who is the study for?

This trial is for young adults in the U.S., aged 18-30, who can read English and want to quit smoking. They must have smoked over 100 cigarettes in their lifetime and currently smoke at least once on three days each week. Participants need to own a smartphone and plan to quit within the next month.

What is being tested?

The study tests if messages sent through smartphones using cognitive behavioral therapy (CBT) or Mindfulness/Acceptance and Commitment Therapy (ACT) help young adults stop smoking. It focuses on sending support during high-risk situations that trigger the urge to smoke.

What are the potential side effects?

Since this intervention involves only messaging support without any medication, there are no direct physical side effects expected from participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Change in smoking urge as assessed by a single item

Secondary study objectives

Activity completion as assessed by a single item

Change in cigarettes smoked as assessed by a single item

Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Micro-randomized trial groupExperimental Treatment1 Intervention

The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).

Group II: EMA-only control groupActive Control1 Intervention

A total of N=80 participants will be randomized into an EMA-only control group, parallel to the micro-randomized trial intervention group. This group will conduct 14-day EMA only training phase just like the micro-randomized trial group, but will not be switched over to the intervention phase after these initial 14 days. Instead, participants will continue the EMA-only data collection procedure for an additional 30-days (analogous to the 30-day intervention phase of the micro-randomized trial). During these 30 days, the EMA-only control group will continue to receive 3 randomly prompted EMA surveys per day and an additional 3 EMA surveys triggered by smoking reports.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Smartphone-based intervention messages

2023

N/A

~10

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