Smoking CessationNCT03565497
Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
A study testing Mindfulness Training and Mindfulness Training Plus IE in people with Smoking Cessation, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Specific Aims for this Project Are: 1. To evaluate the ability of two forms of mindfulness training, relative to a control intervention, to engage specific "triple-vulnerability" mechanistic targets that characterize low SES smokers. 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mindfulness Training and Mindfulness Training Plus IE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 31 Aug 2021
- 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
- be between 18 and 65 years of agehave reported household income of less than 1.5Xpoverty guidelines
- be a regular smoker for at least one year
- report daily smoking (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis; > .10ppm CO)
- not be presently engaged in a quit attempt
Who cannot join
- History of psychosis as determined by a brief psychotic screen, pregnancy, nursing mothers, medical conditions that would contraindicate smoking (e.g., current diagnoses of chronic medical diseases including heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment via medical checklist), nicotine use other than cigarette smoking, current use of any pharmacotherapy for smoking cessation, or insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text).
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aims for this Project Are:
- To evaluate the ability of two forms of mindfulness training, relative to a control intervention, to engage specific "triple-vulnerability" mechanistic targets that characterize low SES smokers.
- The investigators hypothesize that both versions of the mindfulness training will show greater target engagement than the control treatment for mechanistic targets assessed under standard smoking conditions.
- The investigators hypothesize that the enhanced mindfulness training, Mindfulness+IE, will show greater target engagement than the other two conditions for mechanistic targets assessed during the nicotine deprivation window.
- To show that the hypothesized differential target engagement results in differential smoking self-control as evaluated by greater time to lapse, fewer cigarettes smoked, and different smoking topography in the McKee Lapse protocol.
- To expand and refine the list of SOBC targets by showing the specific relationship between currently identified assays and empirically-validated alternative targets, with attention to showing which of the targeted mechanisms in which contexts are most linked to clinically-relevant outcomes assessed in the McKee protocol, and which offer redundant or non-significant prediction.
Read the detailed description
This study is designed to evaluate the success of mechanistic target engagement in two specific contexts: under standard smoking conditions and under nicotine deprivation (stress) conditions. After screening, consent, and baseline assessment, participants selected on the basis of inclusion/exclusion criteria will be randomized to one of three intervention conditions: (1) a health-education control condition (CC), (2) a mindfulness training condition (MT), or (3) a mindfulness training condition combined with training applying mindfulness skills in the context of interoceptive exposure (Mindfulness+IE). Following 6 sessions of these interventions, delivered over 3 weeks, participants will then undergo the standard smoking assessment of mechanistic targets. Two days later (and matching the progression to quit-attempt challenges following treatment), participants will undergo the deprivation window assessment (14 hours of smoking abstinence) of these same mechanistic targets, followed by evaluation of lapse behavior and smoking topography in the McKee paradigm to yield: (1) latency to initiate smoking during a monetarily reinforced delay period, (2) the number of cigarettes smoked during a subsequent 60-minute self-administration period, and (3) exploratory analysis of smoking topography: puff volume, puff duration, and inter-puff interval. Participants will be recruited to Boston University through study advertisements targeted to low SES neighborhoods, with attention to health service centers and religious institutions serving low SES individuals.
Following telephone screening for basic eligibility, participants will be scheduled for an informed consent interview and subsequent baseline assessment session. Interventions are to be completed over the subsequent 3 weeks, and post-treatment assessments of the mechanistic targets are scheduled for one-week (standard smoking assessment) and one week + 2 days (deprivation-window assessment) from the last intervention session. For the standard smoking window assessments, participants are asked to smoke .5 hour before the scheduled assessment session. The deprivation-window assessment is scheduled two days later, (for example, scheduled for 12:00 noon, with smoking to cease at 10PM the night before). Upon arrival to the lab, nicotine abstinence will be verified by expired CO levels, as determined by a cut-off of half of the participant's screening session CO concentration or <10 PPM (those failing will be rescheduled). After verification of abstinence, participants will complete assessment of the triple-risk mechanistic target variables. These assessments will be followed by the McKee Lapse protocol: participants will be instructed that over the next 50 min, they will have the option to initiate a cigarette self-administration (smoking) session at any point or to delay initiation in exchange for monetary reinforcement. If participants choose to delay, they will be awarded funds for each 5-minute increment they are able to resist smoking. Once participants choose to end the delay period in order to smoke (or resist smoking for the entire 50 minute delay period), they will then participate in a 60-minute cigarette self-administration session, in which they will be given the choice to either smoke their preferred brand of cigarettes or receive monetary reinforcement for cigarettes not smoked. Participants will be given funds at the beginning of the self-administration session and will lose a portion of the funds for each cigarette smoked. When participants smoke in this protocol, we will use the Clinical Research Support System (CReSS) to measure smoking topography. The reliability and acceptability of use of the portable CReSS device is well documented,88,94 and is recommended over direct observation. Topography data will include puff CO volume, puff duration, and inter-puff interval. Puff level data will be averaged to compute mean topography variables for each participant.
- Conditions
- Smoking Cessation
- Being tested
- Wellness Education Control Condition, Mindfulness Training, Mindfulness Training Plus IE
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Education Control ConditionBehavioural
As per arm of the same name
Mindfulness TrainingBehavioural
As per arm of the same name
Mindfulness Training Plus IEBehavioural
As per arm of the same name
| Study group | Role | What they receive |
|---|---|---|
| Wellness Education Control Condition | Placebo comparator | The wellness education control condition (CC) is modeled after that used in our studies of exercise for smoking cessation, but delivered in an individual format. Content focuses on discussions of a variety of healthy lifestyle topics, such as healthy eating, time management, recommended health screenings, and cancer and cardiovascular prevention. Content is delivered using a combination of lectures, videos, handouts, and discussions while allowing participants to set their own realistic wellness goals, which they can gradually incorporate into their lives. Receives: Behavioral: Wellness Education Control Condition |
| Mindfulness Training (MT) | Experimental | Mindfulness training will be adapted for 6 individual sessions;elements include: (1) a body scan designed to teach participants to pay attention to specific parts of their bodies as a strategy to increase attentional capacities/reduce habitual mind-wandering; (2) non-judgmental awareness, and (3) 'awareness of breath' meditation, with an additional focus on helping participants become more aware of the present moment and refrain from habitually engaging in self-related pre-occupations concerning the future or the past. Receives: Behavioral: Mindfulness Training |
| Mindfulness Training Plus IE (MT+IE) | Experimental | This condition will mirror the MT condition for the first 4 individual sessions, then for the final 2 individual sessions, MT will be rehearsed under conditions of sensations of anxiety/tension induced by interoceptive exposure procedures (IE). Receives: Behavioral: Mindfulness Training Plus IE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Affect
PANAS-State Negative was used to assess the mechanistic outcome of Negative Affectivity/Stress. Items from the negative subscale are summed to create a total score. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Measured: 1-week Post-Intervention Smoking Context
Negative Affect/Withdrawal
Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.
Measured: 1-week Post-Intervention Smoking Context
N-Back Task
Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.
Measured: 1-week Post-Intervention Smoking Context
Spatial Span
The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.
Measured: 1-week Post-Intervention Smoking Context
Digit Span
The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.
Measured: 1-week Post-Intervention Smoking Context
Anxiety Sensitivity
The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.
Measured: 1-week Post-Intervention Smoking Context
Mirror-Tracing Persistence Task
The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.
Measured: 1-week Post-Intervention Smoking Context
Negative Affect
PANAS-State Negative was used to assess the mechanistic outcome of Negative Affectivity/Stress. Items from the negative subscale are summed to create a total score. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Measured: 1week+2days Post-Intervention Deprivation Context
Negative Affect/Withdrawal
Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.
Measured: 1week+2days Post-Intervention Deprivation Context
N-Back Task
Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.
Measured: 1week+2days Post-Intervention Deprivation Contex
Spatial Span
The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.
Measured: 1week+2days Post-Intervention Deprivation Contex
Digit Span
The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.
Measured: 1week+2days Post-Intervention Deprivation Context
Anxiety Sensitivity
The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.
Measured: 1week+2days Post-Intervention Deprivation Contex
Mirror-Tracing Persistence Task
The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.
Measured: 1week+2days Post-Intervention Deprivation Context
Secondary outcomes (5)
McKee Protocol Delay Until Smoking
Degree of delay (in minutes) until smoking in the McKee protocol. The number of minutes the participant went during the delay period without smoking is reported. If the participant did not smoke at all during the delay period, the value is 50.
Measured: 1week+2days Post-Intervention Deprivation Context
McKee Protocol Number of Cigarettes Smoked
Number of cigarettes smoked in the 60 minute self-administration session. No value is entered if the participant did not smoke a cigarette during the session at all. Otherwise, the number reported is the number of cigarettes the participant smoked during the session.
Measured: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-1
Puff CO volume. During administration of this assessment, there was equipment failure. For this reason, no participants had valid data collected or analyzed for this measure.
Measured: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-2
Puff CO volume. During administration of this assessment, there was equipment failure. For this reason, no participants had valid data collected or analyzed for this measure.
Measured: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-3
Inter-puff interval. During administration of this assessment, there was equipment failure. For this reason, no participants had valid data collected or analyzed for this measure.
Measured: 1week+2days Post-Intervention Deprivation Context
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start19 Apr 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: COVID-19 pandemic caused human subjects research to shut down and study was unable to restart.
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 (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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565497
- Sponsor's protocol ID
- DA046963
- Status last verified
- Jul 2022
- First submitted
- 29 May 2018
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within one year of completion (publication) of the primary Aims for this project, we will provide de-identified data from this project to interested researchers. The data is to be provided in a SAS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Otto's team at Boston University to investigators providing evidence of their institution's approval for planned analyses of the data.
Publications
Otto MW, Zvolensky MJ, Rosenfield D, Hoyt DL, Witkiewitz K, McKee SA, Bickel WK, Smits JAJ. A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults. Health Psychol. 2020 Sep;39(9):815-825. doi: 10.1037/hea0000858.
PubMed 32833483
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
- ClinicalTrials.gov ID
- NCT03565497
- Acronym / sponsor ID
- DA046963
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic caused human subjects research to shut down and study was unable to restart.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aims for this Project Are:
- To evaluate the ability of two forms of mindfulness training, relative to a control intervention, to engage specific "triple-vulnerability" mechanistic targets that characterize low SES smokers.
- The investigators hypothesize that both versions of the mindfulness training will show greater target engagement than the control treatment for mechanistic targets assessed under standard smoking conditions.
- The investigators hypothesize that the enhanced mindfulness training, Mindfulness+IE, will show greater target engagement than the other two conditions for mechanistic targets assessed during the nicotine deprivation window.
- To show that the hypothesized differential target engagement results in differential smoking self-control as evaluated by greater time to lapse, fewer cigarettes smoked, and different smoking topography in the McKee Lapse protocol.
- To expand and refine the list of SOBC targets by showing the specific relationship between currently identified assays and empirically-validated alternative targets, with attention to showing which of the targeted mechanisms in which contexts are most linked to clinically-relevant outcomes assessed in the McKee protocol, and which offer redundant or non-significant prediction.
Detailed description
This study is designed to evaluate the success of mechanistic target engagement in two specific contexts: under standard smoking conditions and under nicotine deprivation (stress) conditions. After screening, consent, and baseline assessment, participants selected on the basis of inclusion/exclusion criteria will be randomized to one of three intervention conditions: (1) a health-education control condition (CC), (2) a mindfulness training condition (MT), or (3) a mindfulness training condition combined with training applying mindfulness skills in the context of interoceptive exposure (Mindfulness+IE). Following 6 sessions of these interventions, delivered over 3 weeks, participants will then undergo the standard smoking assessment of mechanistic targets. Two days later (and matching the progression to quit-attempt challenges following treatment), participants will undergo the deprivation window assessment (14 hours of smoking abstinence) of these same mechanistic targets, followed by evaluation of lapse behavior and smoking topography in the McKee paradigm to yield: (1) latency to initiate smoking during a monetarily reinforced delay period, (2) the number of cigarettes smoked during a subsequent 60-minute self-administration period, and (3) exploratory analysis of smoking topography: puff volume, puff duration, and inter-puff interval. Participants will be recruited to Boston University through study advertisements targeted to low SES neighborhoods, with attention to health service centers and religious institutions serving low SES individuals.
Following telephone screening for basic eligibility, participants will be scheduled for an informed consent interview and subsequent baseline assessment session. Interventions are to be completed over the subsequent 3 weeks, and post-treatment assessments of the mechanistic targets are scheduled for one-week (standard smoking assessment) and one week + 2 days (deprivation-window assessment) from the last intervention session. For the standard smoking window assessments, participants are asked to smoke .5 hour before the scheduled assessment session. The deprivation-window assessment is scheduled two days later, (for example, scheduled for 12:00 noon, with smoking to cease at 10PM the night before). Upon arrival to the lab, nicotine abstinence will be verified by expired CO levels, as determined by a cut-off of half of the participant's screening session CO concentration or <10 PPM (those failing will be rescheduled). After verification of abstinence, participants will complete assessment of the triple-risk mechanistic target variables. These assessments will be followed by the McKee Lapse protocol: participants will be instructed that over the next 50 min, they will have the option to initiate a cigarette self-administration (smoking) session at any point or to delay initiation in exchange for monetary reinforcement. If participants choose to delay, they will be awarded funds for each 5-minute increment they are able to resist smoking. Once participants choose to end the delay period in order to smoke (or resist smoking for the entire 50 minute delay period), they will then participate in a 60-minute cigarette self-administration session, in which they will be given the choice to either smoke their preferred brand of cigarettes or receive monetary reinforcement for cigarettes not smoked. Participants will be given funds at the beginning of the self-administration session and will lose a portion of the funds for each cigarette smoked. When participants smoke in this protocol, we will use the Clinical Research Support System (CReSS) to measure smoking topography. The reliability and acceptability of use of the portable CReSS device is well documented,88,94 and is recommended over direct observation. Topography data will include puff CO volume, puff duration, and inter-puff interval. Puff level data will be averaged to compute mean topography variables for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wellness Education Control Condition | Placebo comparator | Behavioral: Wellness Education Control ConditionThe wellness education control condition (CC) is modeled after that used in our studies of exercise for smoking cessation, but delivered in an individual format. Content focuses on discussions of a variety of healthy lifestyle topics, such as healthy eating, time management, recommended health screenings, and cancer and cardiovascular prevention. Content is delivered using a combination of lectures, videos, handouts, and discussions while allowing participants to set their own realistic wellness goals, which they can gradually incorporate into their lives. |
| Mindfulness Training (MT) | Experimental | Behavioral: Mindfulness TrainingMindfulness training will be adapted for 6 individual sessions;elements include: (1) a body scan designed to teach participants to pay attention to specific parts of their bodies as a strategy to increase attentional capacities/reduce habitual mind-wandering; (2) non-judgmental awareness, and (3) 'awareness of breath' meditation, with an additional focus on helping participants become more aware of the present moment and refrain from habitually engaging in self-related pre-occupations concerning the future or the past. |
| Mindfulness Training Plus IE (MT+IE) | Experimental | Behavioral: Mindfulness Training Plus IEThis condition will mirror the MT condition for the first 4 individual sessions, then for the final 2 individual sessions, MT will be rehearsed under conditions of sensations of anxiety/tension induced by interoceptive exposure procedures (IE). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be between 18 and 65 years of agehave reported household income of less than 1.5Xpoverty guidelines
- be a regular smoker for at least one year
- report daily smoking (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis; > .10ppm CO)
- not be presently engaged in a quit attempt
Key exclusion criteria (1 listed)
- History of psychosis as determined by a brief psychotic screen, pregnancy, nursing mothers, medical conditions that would contraindicate smoking (e.g., current diagnoses of chronic medical diseases including heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment via medical checklist), nicotine use other than cigarette smoking, current use of any pharmacotherapy for smoking cessation, or insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text).
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 |
|---|---|---|
| Wellness Education Control ConditionAs per arm of the same name | Behavioural | Wellness Education Control Condition |
| Mindfulness TrainingAs per arm of the same name | Behavioural | Mindfulness Training (MT) |
| Mindfulness Training Plus IEAs per arm of the same name | Behavioural | Mindfulness Training Plus IE (MT+IE) |
Primary outcome
Negative Affect
Time frame: 1-week Post-Intervention Smoking Context
PANAS-State Negative was used to assess the mechanistic outcome of Negative Affectivity/Stress. Items from the negative subscale are summed to create a total score. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Negative Affect/Withdrawal
Time frame: 1-week Post-Intervention Smoking Context
Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.
N-Back Task
Time frame: 1-week Post-Intervention Smoking Context
Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.
Spatial Span
Time frame: 1-week Post-Intervention Smoking Context
The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.
Digit Span
Time frame: 1-week Post-Intervention Smoking Context
The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.
Anxiety Sensitivity
Time frame: 1-week Post-Intervention Smoking Context
The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.
Mirror-Tracing Persistence Task
Time frame: 1-week Post-Intervention Smoking Context
The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.
Negative Affect
Time frame: 1week+2days Post-Intervention Deprivation Context
PANAS-State Negative was used to assess the mechanistic outcome of Negative Affectivity/Stress. Items from the negative subscale are summed to create a total score. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Negative Affect/Withdrawal
Time frame: 1week+2days Post-Intervention Deprivation Context
Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.
N-Back Task
Time frame: 1week+2days Post-Intervention Deprivation Contex
Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.
Spatial Span
Time frame: 1week+2days Post-Intervention Deprivation Contex
The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.
Digit Span
Time frame: 1week+2days Post-Intervention Deprivation Context
The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.
Anxiety Sensitivity
Time frame: 1week+2days Post-Intervention Deprivation Contex
The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.
Mirror-Tracing Persistence Task
Time frame: 1week+2days Post-Intervention Deprivation Context
The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.
5 secondary outcomes
McKee Protocol Delay Until Smoking
Time frame: 1week+2days Post-Intervention Deprivation Context
McKee Protocol Number of Cigarettes Smoked
Time frame: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-1
Time frame: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-2
Time frame: 1week+2days Post-Intervention Deprivation Context
Smoking Topography-3
Time frame: 1week+2days Post-Intervention Deprivation Context
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32833483Otto MW, Zvolensky MJ, Rosenfield D, Hoyt DL, Witkiewitz K, McKee SA, Bickel WK, Smits JAJ. A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults. Health Psychol. 2020 Sep;39(9):815-825. doi: 10.1037/hea0000858.
- Individual participant dataSharing planned: Yes. Within one year of completion (publication) of the primary Aims for this project, we will provide de-identified data from this project to interested researchers. The data is to be provided in a SAS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Otto's team at Boston University to investigators providing evidence of their institution's approval for planned analyses of the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Training and Mindfulness Training Plus IE in people with Smoking Cessation, run by Boston University Charles River Campus 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 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?
Yes. Results are posted in the registry (first posted 17 May 2023). 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?
Negative Affect (time frame: 1-week Post-Intervention Smoking Context). The study lists 14 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 NCT03565497, 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 17 May 2023.