Cigarette SmokingNCT03029819
iQuit Mindfully: Text Messaging for Smoking Cessation
A study testing Mindfulness-based Addiction Treatment, iQuit Mindfully and Self-Help guide in people with Cigarette Smoking, run by Georgia State University at 1 site in United States.
Trial summary
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Mindfulness-based Addiction Treatment, iQuit Mindfully and Self-Help guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 3 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- current smoker with history of >5 cigarettes/day for past year (and expired carbon monoxide >6 parts per million [ppm])
- motivated to quit within next 30 days
- valid home address in the greater Atlanta, Georgia area
- functioning telephone number
- own a mobile phone with text messaging capacity
- can speak, read, and write in English
- at least a sixth-grade level of health literacy
Who cannot join
- contraindication for nicotine patch
- active substance abuse/dependence
- regular use of tobacco products other than cigarettes
- current use of tobacco cessation medications
- pregnancy or lactation
- household member enrolled in the study
- current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
- clinically significant depressive symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.
Read the detailed description
This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).
All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.
- Conditions
- Cigarette Smoking
- Being tested
- Mindfulness-based Addiction Treatment, iQuit Mindfully, Self-Help guide, Nicotine Patch
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Addiction TreatmentBehavioural
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit MindfullyBehavioural
Also called Mindfulness-based text messaging for smoking cessation
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guideBehavioural
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Nicotine PatchDrug
Also called Generic Nicotine Patch
Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) | Active comparator | Nicotine patch; self-help guide; MBAT Receives: Behavioral: Mindfulness-based Addiction Treatment; Behavioral: Self-Help guide; Drug: Nicotine Patch |
| iQuit Mindfully | Experimental | Nicotine patch; self-help guide; MBAT; text messaging Receives: Behavioral: Mindfulness-based Addiction Treatment; Behavioral: iQuit Mindfully; Behavioral: Self-Help guide; Drug: Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)
Measured: End of Treatment (8 weeks)
Secondary outcomes (3)
Participant Engagement
Number of participants who respond to interactive text messages
Measured: Over the 8-week treatment period
Participant Ratings
Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome)
Measured: End of Treatment (8 weeks)
Attrition
Number of participants who do not attend end-of-treatment session
Measured: End of treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start18 Jan 2017
- Primary completion10 Aug 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Utah, The Catholic University of America, George Washington University, University of Chicago
- Responsible party
- Principal investigator, Claire Spears, Georgia State University
- Investigators
- Claire A Spears, Ph.D., Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029819
- Sponsor's protocol ID
- K23AT008442
- Other IDs
- K23AT008442
- Status last verified
- Dec 2018
- First submitted
- 16 Jan 2017
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
PubMed 27213492Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
PubMed 18617085Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.
PubMed 31237242
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
- ClinicalTrials.gov ID
- NCT03029819
- Acronym / sponsor ID
- K23AT008442
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Utah, The Catholic University of America, George Washington University, University of Chicago
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.
Detailed description
This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).
All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) | Active comparator | Behavioral: Mindfulness-based Addiction Treatment, Behavioral: Self-Help guide, Drug: Nicotine PatchNicotine patch; self-help guide; MBAT |
| iQuit Mindfully | Experimental | Behavioral: Mindfulness-based Addiction Treatment, Behavioral: iQuit Mindfully, Behavioral: Self-Help guide, Drug: Nicotine PatchNicotine patch; self-help guide; MBAT; text messaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18-65 years
- current smoker with history of >5 cigarettes/day for past year (and expired carbon monoxide >6 parts per million [ppm])
- motivated to quit within next 30 days
- valid home address in the greater Atlanta, Georgia area
- functioning telephone number
Key exclusion criteria (8 listed)
- contraindication for nicotine patch
- active substance abuse/dependence
- regular use of tobacco products other than cigarettes
- current use of tobacco cessation medications
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Addiction TreatmentMindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009). | Behavioural | Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully |
| iQuit MindfullyAlso: Mindfulness-based text messaging for smoking cessationiQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation. | Behavioural | iQuit Mindfully |
| Self-Help guideSelf-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008). | Behavioural | Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully |
| Nicotine PatchAlso: Generic Nicotine PatchPatch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. | Drug | Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully |
Primary outcome
Smoking Abstinence
Time frame: End of Treatment (8 weeks)
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)
3 secondary outcomes
Participant Engagement
Time frame: Over the 8-week treatment period
Participant Ratings
Time frame: End of Treatment (8 weeks)
Attrition
Time frame: End of treatment (8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27213492Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
- Background: PubMed 18617085Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
- Derived from this study: PubMed 31237242Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire A Spears, Ph.D. principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Addiction Treatment, iQuit Mindfully and Self-Help guide in people with Cigarette Smoking, run by Georgia State University 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 8 inclusion and 8 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 8 Jan 2019. 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. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Abstinence (time frame: End of Treatment (8 weeks)). 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 NCT03029819, which also lists 3 linked publications.
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 8 Jan 2019.