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Smoking CessationNCT05440903

Mindfulness Training for Smoking Cessation

A study testing Headspace and TEDTalk in people with Smoking Cessation, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Participants will complete this study remotely, either at home or at their preferred location using an online platform. The investigators propose to test the effects of a mindfulness training [MT: Headspace] intervention compared to a time and attention psycho-education control [control: TedTalks] among N=200 adult… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Headspace and TEDTalk
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
1 siteUnited States
Study dates
8 Dec 2020to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Smoke at least 5 cig/day for the past year
  • English fluency
  • Motivation to quit smoking in next 30 days, or willing to make a practice quit attempt
  • Reside in California
  • Have remote video capability (i.e., computer, laptop, tablet with working camera and audio) in order to complete all data collection procedures (Note that the study does not have resources to provide these materials)
  • Have working smartphone capable of downloading the app for EMA assessments

Who cannot join

  • Current use of any nicotine replacement products (i.e., nicotine patch, gum, lozenge) or smoking cessation medications (i.e., Chantix, Bupropion, Wellbutrin, Zyban)
  • Current mindfulness or meditation practice of greater than 5 minutes each day.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Keck School of Medicine of USC

    Los Angeles, California, 90032

Other trials in United States

About this study

Official title: Examining the Effects of Brief Mindfulness Training on Smoking Quit Attempts

Participants will complete this study remotely, either at home or at their preferred location using an online platform. The investigators propose to test the effects of a mindfulness training [MT: Headspace] intervention compared to a time and attention psycho-education control [control: TedTalks] among N=200 adult smokers of a nicotine product. Previous studies suggest that mindfulness training may be beneficial in reducing craving during tobacco abstinence. During the study, participants will complete baseline questionnaires, followed by two weeks of daily MT or control training and self-report on questionnaires assessing affect, cognition, and smoking behavior using Ecological Momentary Assessment (EMA) for remote data capture. Following this two weeks of training, participants will complete a smoking quit attempt and complete daily EMA questionnaires for two weeks. The first day of the smoking quit attempt will include a remote Zoom video session following overnight smoking abstinence. During this session the participants will complete a remote stressor task (Trier Social Stress Test, TSST), and the investigators will collect EMA data on affect and smoking behavior before and after the TSST. One month after the start of the quit attempt, participants will complete a phone call as a follow-up to assess smoking behavior over the previous 30 days, and to complete a debriefing. Study objectives are to test the effect of MT on: (1) smoking lapses during the follow-up periods; and (2) stress (affect, smoking urge, withdrawal symptoms) during the TSST.

Being tested
Headspace, TEDTalk
Keywords
Mindfulness, Meditation
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeadspaceBehavioural

    Also called Mindfulness

    A smartphone application that provides users with mindfulness and meditation sessions.

  • TEDTalkBehavioural

    A smartphone application that provides users with psychoeducational audio recordings from TEDTalk.

Study groups in NCT05440903
Study groupRoleWhat they receive
MindfulnessExperimentalParticipants in the experimental arm are asked to use a mindfulness smartphone application called Headspace. Headspace offers pre-recorded introductory mindfulness meditation audio instructions guided by experienced meditation teachers. Study participants are instructed to voluntarily complete 10 minutes of Headspace twice per day for 14 days, a total recommended dose of 280 minutes. Mindfulness practice begins the day after the baseline interview (i.e., intervention day 1). Participants are encouraged to listen at two separate times each day to support habit formation and to maximize daily exposure with low time burden. As participants have minimal prior experience with mindfulness attributed to the study eligibility criteria, all recommended trainings are at the beginner level. Participants have access to all sessions offered and are not restricted to a particular sequence.
Receives: Behavioral: Headspace
PsychoeducationPlacebo comparatorParticipants in the psychoeducation arm listen to TEDTalks audio recordings by experts on field-specific topics. Study participants are instructed to complete 10 minutes of TEDTalks twice per day for 14 days. Sessions were selected by the study team to be of interest to the public yet not include content on meditation, smoking, or content appearing to cue behavior change associated with smoking. Like the Mindfulness condition, participants in the Psychoeducation condition begin the practice the day after the baseline interview. Participants are told to listen at two separate times each day to maximize daily exposure with low time burden. Additionally, participants are instructed to listen with "full mindful attention and return attention to the audio when attention drifts" to match the Mindfulness instruction and emphasize the importance of sustaining attention for each 10-minute period. Participants have access to all sessions offered and are not restricted to a particular sequence.
Receives: Behavioral: TEDTalk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Cessation Behavior at 14 days

    7-day point prevalence abstinence (i.e., no cigarettes smoked in the previous 7 days). 0=did not smoke; 1=smoked at least one cigarette.

    Measured: 14 days after start of quit attempt

  2. Smoking Cessation Behavior at 30 days

    7-day point prevalence abstinence (i.e., no cigarettes smoked in the previous 7 days). 0=did not smoke; 1=smoked at least one cigarette.

    Measured: 30 days after start of quit attempt

Secondary outcomes (6)

  1. Cessation Motivation

    change in motivation to quit (or stay quit) as measured by the Contemplation Ladder, a visual graphic used to select current level of quit motivation (0="no thought of quitting"; 10="taking action to quit"). A higher number indicates greater motivation to quit smoking.

    Measured: baseline (start of the study) and 30 days after start of quit attempt

  2. App training adherence

    Adherence to app use will be calculated as the number of times an individual used the app out of a total of 28 sessions (2 session per day for 14 days). A higher number indicates better adherence.

    Measured: 14 days after starting app training

  3. Stress-related feelings of "anxious"

    visual analog scales of "I feel anxious" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "anxious"

    Measured: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST

  4. Stress-related feelings of "relaxed"

    visual analog scales of "I feel relaxed" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "relaxed"

    Measured: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST

  5. Stress-related feelings of "stressed"

    visual analog scales of "I feel stressed" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "stressed"

    Measured: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST

  6. Stress-related feelings of "urge to smoke"

    visual analog scales of "I have an urge to smoke" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "urge to smoke"

    Measured: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start8 Dec 2020
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Between-groups study design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05440903
Sponsor's protocol ID
UP-20-00900
Status last verified
Sep 2023
First submitted
22 Jun 2022
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators plan on sharing deidentified data with other researchers by request.

Publications

  • Black DS, Kirkpatrick M. Test of daily app-based mindfulness meditation preceding a planned smoking quit attempt date on abstinence: Protocol for a randomized controlled trial recruiting across the 58 counties of California. Contemp Clin Trials. 2022 Sep;120:106855. doi: 10.1016/j.cct.2022.106855. Epub 2022 Jul 18.

    PubMed 35863695

Questions about this trial

What is this clinical trial studying?

A study testing Headspace and TEDTalk in people with Smoking Cessation, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Cessation Behavior at 14 days (time frame: 14 days after start of quit attempt). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05440903, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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