Smoking CessationNCT02742610
Smoking Cessation Intervention for Smokers With Depression Receiving Outpatient Psychiatric Treatment
A study testing Mindfulness with Contingency Management in people with Smoking Cessation, run by Fordham University at 1 site in United States.
Trial summary
This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mindfulness with Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 18 years of age
- be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
- English-speaking
- motivated to quit smoking (i.e., "intent to quit in the next 3 months")
- have a diagnosis of depressive or bipolar disorders
- engaged in outpatient psychiatric treatment (i.e., has been receiving outpatient psychiatric treatment for at least 3 months AND has received counseling from social worker at outpatient psychiatric treatment clinic at least 3 times in the past 3 months)
Who cannot join
- acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
- diagnosis of psychotic disorders
- current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
- patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
- current clinical diagnosis of intellectual development disorder or autistic disorder
- current (non-nicotine) substance use disorder with the exception of individuals holding 6 months of sobriety and/or receiving treatment including counseling and medications (i.e. methadone, suboxone)
Show all 11Show fewer
- intention to quit smoking using pharmacotherapy other than transdermal nicotine patches
- pregnant, breastfeeding, or planning to become pregnant within 6 months
- significant history of cardiovascular disease (a standard contraindication for nicotine patch use),
- patient does not have a stable home address where the research team could reliably reach patient, or
- regular (3 or more times in the past month) use of other tobacco products (i.e., cigars, cigarillos, chewing tobacco) or marijuana
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Brief Mindfulness Cessation Training With EMA for Post-hospital Depressed Smokers
This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. This project is expected to result in the development of an effective intervention that will produce preliminary data showing increased short-term cessation success in depressed smokers receiving outpatient psychiatric treatment. It is anticipated that this smoking cessation intervention will have potential for broad reach to outpatient psychiatric treatment programs and have a significant overall impact in reducing smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk populations.
Read the detailed description
The proposed study will develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. The intervention will involve a series of brief mindfulness training that will be delivered via smartphone, that prompts patients to practice a mindfulness exercise multiple times a day while abstinent: 1) 10-days prior to their target quit date and 2) during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following their target quit date. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training due to its utility in producing short-term abstinence, so as to provide opportunities to practice mindfulness without smoking in one's natural environment. We will accomplish this objective by pursuing the following specific aims (in 2 phases):
Phase 1: To develop the MSI-CM intervention intended to improve smoking cessation success among depressed smokers receiving outpatient psychiatric treatment.
1a. We will collaborate with TelASK, Inc. to develop a prototype of a smartphone intervention (MSI-CM).
1b. We will conduct preliminary pilot testing of MSI-CM, in an iterative fashion, with 10 smokers receiving outpatient psychiatric treatment for depression.
Phase 2: To conduct a preliminary, randomized controlled trial (RCT) with depressed 60 smokers receiving outpatient psychiatric treatment.
- Conditions
- Smoking Cessation
- Being tested
- Mindfulness with Contingency Management, Active Control
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness with Contingency ManagementBehavioural
Active ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness with Contingency Management | Experimental | The intervention (MSI-CM) will involve two individual pre-quit in-person sessions and two post-quit phone counseling sessions, a series of brief mindfulness trainings that will be delivered via smartphone, that prompts participants to practice a mindfulness exercise five times a day while abstinent during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following the participant's target quit date. The MSI-CM participants will be asked to provide CO video via smartphone twice daily with monetary incentives provided (CM). Participants will receive monetary incentives contingent on each confirmed CO level (less than 7 ppm) for the CM period. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training. Receives: Behavioral: Mindfulness with Contingency Management |
| Active Control | Active comparator | Participants assigned to the control group will receive two individual pre-quit in-person sessions and two post-quit phone counseling sessions, similar to the MSI-CM except for mindfulness introduction/discussion. Participants in the control group will receive the same monetary incentives on average as the participants in the MSI-CM for submitting CO videos, regardless of CO levels (non-abstinent contingent), during the 2-week post-TQD period. Each participant in the group (the non-contingent CO group) will be yoked to a single participant (selected randomly with stratification) in the MSI-CM. The yoked participant receives the same amount of monetary incentives as his or her matched participant in the contingent CO (MSI-CM) group. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status
Self-reports of smoking status and verification via CO will be collected at 2-week, 4-week, and 3-month (cotinine level) post-target quit date assessment. The main outcome analyses are based upon 7-day point prevalence abstinence (PPA). As a secondary approach, we will use the timeline followback (TLFB) procedure for assessing the longitudinal course of smoking outcomes. Our approach permits us to follow the standard NCI and NHLBI guidelines for measurement. Biochemical Verification. Self-reported abstinence will be verified by carbon monoxide (CO) analysis of breath samples (6 ppm cutoff) for abstinence of 24 hours to one week for 3-month follow-up. Values above the cutoff will be considered indicative of smoking.
Measured: 2-week, 4-week, and 3-month post-target quit date assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fordham University
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, University of Texas at Austin, William Marsh Rice University
- Responsible party
- Sponsor
- Investigators
- Haruka Minami, Ph.D., Principal investigator, Fordham Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742610
- Sponsor's protocol ID
- 1R34DA037364-01A1
- Status last verified
- Jan 2019
- First submitted
- 3 Feb 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Minami H, Nahvi S, Arnsten JH, Brinkman HR, Rivera-Mindt M, Wetter DW, Bloom EL, Price LH, Richman EK, Betzler TF, Stockmal C, Donnelly R, McClain LM, Kennedy KA, Vieira C, Fine M, McCarthy DE, Thomas JG, Hecht J, Brown RA. A pilot randomized controlled trial of smartphone-assisted mindfulness-based intervention with contingency management for smokers with mood disorders. Exp Clin Psychopharmacol. 2022 Oct;30(5):653-665. doi: 10.1037/pha0000506. Epub 2021 Jul 22.
PubMed 34291992
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness Cessation Training With EMA for Post-hospital Depressed Smokers
- ClinicalTrials.gov ID
- NCT02742610
- Acronym / sponsor ID
- 1R34DA037364-01A1
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fordham UniversityUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, University of Texas at Austin, William Marsh Rice University
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. This project is expected to result in the development of an effective intervention that will produce preliminary data showing increased short-term cessation success in depressed smokers receiving outpatient psychiatric treatment. It is anticipated that this smoking cessation intervention will have potential for broad reach to outpatient psychiatric treatment programs and have a significant overall impact in reducing smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk populations.
Detailed description
The proposed study will develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. The intervention will involve a series of brief mindfulness training that will be delivered via smartphone, that prompts patients to practice a mindfulness exercise multiple times a day while abstinent: 1) 10-days prior to their target quit date and 2) during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following their target quit date. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training due to its utility in producing short-term abstinence, so as to provide opportunities to practice mindfulness without smoking in one's natural environment. We will accomplish this objective by pursuing the following specific aims (in 2 phases):
Phase 1: To develop the MSI-CM intervention intended to improve smoking cessation success among depressed smokers receiving outpatient psychiatric treatment.
1a. We will collaborate with TelASK, Inc. to develop a prototype of a smartphone intervention (MSI-CM).
1b. We will conduct preliminary pilot testing of MSI-CM, in an iterative fashion, with 10 smokers receiving outpatient psychiatric treatment for depression.
Phase 2: To conduct a preliminary, randomized controlled trial (RCT) with depressed 60 smokers receiving outpatient psychiatric treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness with Contingency Management | Experimental | Behavioral: Mindfulness with Contingency ManagementThe intervention (MSI-CM) will involve two individual pre-quit in-person sessions and two post-quit phone counseling sessions, a series of brief mindfulness trainings that will be delivered via smartphone, that prompts participants to practice a mindfulness exercise five times a day while abstinent during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following the participant's target quit date. The MSI-CM participants will be asked to provide CO video via smartphone twice daily with monetary incentives provided (CM). Participants will receive monetary incentives contingent on each confirmed CO level (less than 7 ppm) for the CM period. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training. |
| Active Control | Active comparator | Behavioral: Active ControlParticipants assigned to the control group will receive two individual pre-quit in-person sessions and two post-quit phone counseling sessions, similar to the MSI-CM except for mindfulness introduction/discussion. Participants in the control group will receive the same monetary incentives on average as the participants in the MSI-CM for submitting CO videos, regardless of CO levels (non-abstinent contingent), during the 2-week post-TQD period. Each participant in the group (the non-contingent CO group) will be yoked to a single participant (selected randomly with stratification) in the MSI-CM. The yoked participant receives the same amount of monetary incentives as his or her matched participant in the contingent CO (MSI-CM) group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age
- be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
- English-speaking
- motivated to quit smoking (i.e., "intent to quit in the next 3 months")
- have a diagnosis of depressive or bipolar disorders
Key exclusion criteria (11 listed)
- acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
- diagnosis of psychotic disorders
- current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
- patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
- current clinical diagnosis of intellectual development disorder or autistic disorder
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 with Contingency Management | Behavioural | Mindfulness with Contingency Management |
| Active Control | Behavioural | Active Control |
Primary outcome
Smoking Status
Time frame: 2-week, 4-week, and 3-month post-target quit date assessment visit
Self-reports of smoking status and verification via CO will be collected at 2-week, 4-week, and 3-month (cotinine level) post-target quit date assessment. The main outcome analyses are based upon 7-day point prevalence abstinence (PPA). As a secondary approach, we will use the timeline followback (TLFB) procedure for assessing the longitudinal course of smoking outcomes. Our approach permits us to follow the standard NCI and NHLBI guidelines for measurement. Biochemical Verification. Self-reported abstinence will be verified by carbon monoxide (CO) analysis of breath samples (6 ppm cutoff) for abstinence of 24 hours to one week for 3-month follow-up. Values above the cutoff will be considered indicative of smoking.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 34291992Minami H, Nahvi S, Arnsten JH, Brinkman HR, Rivera-Mindt M, Wetter DW, Bloom EL, Price LH, Richman EK, Betzler TF, Stockmal C, Donnelly R, McClain LM, Kennedy KA, Vieira C, Fine M, McCarthy DE, Thomas JG, Hecht J, Brown RA. A pilot randomized controlled trial of smartphone-assisted mindfulness-based intervention with contingency management for smokers with mood disorders. Exp Clin Psychopharmacol. 2022 Oct;30(5):653-665. doi: 10.1037/pha0000506. Epub 2021 Jul 22.
- Individual participant dataSharing planned: Undecided
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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.
Haruka Minami, Ph.D. principal investigator
Fordham Univeristy
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 with Contingency Management in people with Smoking Cessation, run by Fordham 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 6 inclusion and 11 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 15 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?
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 Status (time frame: 2-week, 4-week, and 3-month post-target quit date assessment visit). 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 NCT02742610, 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 15 Jan 2019.