Smoking Cessation
Conditions
Brief 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. 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. 2. 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. 2. 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. 3. 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.
Interventions
BEHAVIORALWellness Education Control Condition
As per arm of the same name
BEHAVIORALMindfulness Training
As per arm of the same name
BEHAVIORALMindfulness Training Plus IE
As per arm of the same name
Sponsors
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mirror-Tracing Persistence Task | 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/Withdrawal | 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 | 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 | 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 | 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 | 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. |
| Negative Affect | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McKee Protocol Number of Cigarettes Smoked | 1week+2days Post-Intervention Deprivation Context | 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. |
| Smoking Topography-1 | 1week+2days Post-Intervention Deprivation Context | 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. |
| Smoking Topography-2 | 1week+2days Post-Intervention Deprivation Context | 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. |
| Smoking Topography-3 | 1week+2days Post-Intervention Deprivation Context | 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. |
| McKee Protocol Delay Until Smoking | 1week+2days Post-Intervention Deprivation Context | 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. |
Countries
United States
Participant flow
Pre-assignment details
There were three reasons why enrolled participants were not randomized to study groups: lost contact (3 participants), subject withdrew themselves (2 participants) and issues with commuting to study site (1 participant). Six participants dropped out prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Wellness Education Control Condition 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.
Wellness Education Control Condition: As per arm of the same name | 8 |
| Mindfulness Training (MT) 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.
Mindfulness Training: As per arm of the same name | 8 |
| Mindfulness Training Plus IE (MT+IE) 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).
Mindfulness Training Plus IE: As per arm of the same name | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | COVID-19 halt to human subjects research | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Mindfulness Training (MT) | Wellness Education Control Condition | Mindfulness Training Plus IE (MT+IE) |
|---|---|---|---|---|
| Age, Continuous | 47.46 years STANDARD_DEVIATION 10.77 | 45.63 years STANDARD_DEVIATION 13.59 | 49.56 years STANDARD_DEVIATION 8.31 | 47.14 years STANDARD_DEVIATION 10.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 7 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Executive Function (BRIEF A) | 101.50 units on a scale STANDARD_DEVIATION 24.29 | 101.12 units on a scale STANDARD_DEVIATION 27.72 | 91.63 units on a scale STANDARD_DEVIATION 16.19 | 111.75 units on a scale STANDARD_DEVIATION 26.03 |
| Fagerstrom Test for Nicotine Dependence (FTND) | 4.21 units on a scale STANDARD_DEVIATION 2.08 | 4.37 units on a scale STANDARD_DEVIATION 2.77 | 3.13 units on a scale STANDARD_DEVIATION 1.73 | 5.13 units on a scale STANDARD_DEVIATION 1.13 |
| Psychological Distress (Kessler K6+) | 5.38 units on a scale STANDARD_DEVIATION 5.45 | 5.13 units on a scale STANDARD_DEVIATION 4.55 | 2.00 units on a scale STANDARD_DEVIATION 2 | 9.00 units on a scale STANDARD_DEVIATION 6.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 24 Participants | 8 Participants | 8 Participants | 8 Participants |
| Sex/Gender, Customized Reported Gender Female | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Sex/Gender, Customized Reported Gender Male | 17 Participants | 7 Participants | 6 Participants | 4 Participants |
| Sex/Gender, Customized Reported Gender Transgender | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Smoking Urges (QSU) | 37.42 units on a scale STANDARD_DEVIATION 15.79 | 36.75 units on a scale STANDARD_DEVIATION 14.72 | 36.75 units on a scale STANDARD_DEVIATION 14.97 | 38.75 units on a scale STANDARD_DEVIATION 13.38 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
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.
Time frame: 1week+2days Post-Intervention Deprivation Contex
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Anxiety Sensitivity | 6.67 score on a scale | Standard Deviation 10.63 |
| Mindfulness Training (MT) | Anxiety Sensitivity | 14.40 score on a scale | Standard Deviation 11.76 |
| Mindfulness Training Plus IE (MT+IE) | Anxiety Sensitivity | 17.50 score on a scale | Standard Deviation 19.05 |
Primary
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.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Anxiety Sensitivity | 8.00 score on a scale | Standard Deviation 12.96 |
| Mindfulness Training (MT) | Anxiety Sensitivity | 13.67 score on a scale | Standard Deviation 10.41 |
| Mindfulness Training Plus IE (MT+IE) | Anxiety Sensitivity | 22.20 score on a scale | Standard Deviation 9.18 |
Primary
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/.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Digit Span | 6.33 longest span of correct answers | Standard Deviation 1.03 |
| Mindfulness Training (MT) | Digit Span | 5.60 longest span of correct answers | Standard Deviation 1.82 |
| Mindfulness Training Plus IE (MT+IE) | Digit Span | 4.25 longest span of correct answers | Standard Deviation 0.96 |
Primary
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/.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Digit Span | 5.83 longest span of correct answers | Standard Deviation 0.41 |
| Mindfulness Training (MT) | Digit Span | 5.33 longest span of correct answers | Standard Deviation 2.06 |
| Mindfulness Training Plus IE (MT+IE) | Digit Span | 4.20 longest span of correct answers | Standard Deviation 1.3 |
Primary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Mirror-Tracing Persistence Task | 65.67 seconds | Standard Deviation 39.35 |
| Mindfulness Training (MT) | Mirror-Tracing Persistence Task | 137.83 seconds | Standard Deviation 64.43 |
| Mindfulness Training Plus IE (MT+IE) | Mirror-Tracing Persistence Task | 47.91 seconds | Standard Deviation 55.49 |
Primary
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.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Mirror-Tracing Persistence Task | 93.31 seconds | Standard Deviation 68.86 |
| Mindfulness Training (MT) | Mirror-Tracing Persistence Task | 255.85 seconds | Standard Deviation 291.89 |
| Mindfulness Training Plus IE (MT+IE) | Mirror-Tracing Persistence Task | 136.11 seconds | Standard Deviation 112.22 |
Primary
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.
Time frame: 1week+2days Post-Intervention Deprivation Contex
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | N-Back Task | 103.33 score | Standard Deviation 99.49 |
| Mindfulness Training (MT) | N-Back Task | 75.20 score | Standard Deviation 52.79 |
| Mindfulness Training Plus IE (MT+IE) | N-Back Task | 11.50 score | Standard Deviation 8.96 |
Primary
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.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | N-Back Task | 113.00 score | Standard Deviation 84.43 |
| Mindfulness Training (MT) | N-Back Task | 63.17 score | Standard Deviation 53.11 |
| Mindfulness Training Plus IE (MT+IE) | N-Back Task | 69.00 score | Standard Deviation 101.16 |
Primary
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.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Negative Affect | 11.33 score on a scale | Standard Deviation 1.21 |
| Mindfulness Training (MT) | Negative Affect | 12.67 score on a scale | Standard Deviation 3.56 |
| Mindfulness Training Plus IE (MT+IE) | Negative Affect | 24.20 score on a scale | Standard Deviation 9.18 |
Primary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Negative Affect | 10.33 score on a scale | Standard Deviation 0.82 |
| Mindfulness Training (MT) | Negative Affect | 14.40 score on a scale | Standard Deviation 6.12 |
| Mindfulness Training Plus IE (MT+IE) | Negative Affect | 21.25 score on a scale | Standard Deviation 6.4 |
Primary
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.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Negative Affect/Withdrawal | 1.81 score on a scale | Standard Deviation 0.61 |
| Mindfulness Training (MT) | Negative Affect/Withdrawal | 1.84 score on a scale | Standard Deviation 0.19 |
| Mindfulness Training Plus IE (MT+IE) | Negative Affect/Withdrawal | 2.24 score on a scale | Standard Deviation 0.46 |
Primary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Negative Affect/Withdrawal | 1.73 score on a scale | Standard Deviation 0.67 |
| Mindfulness Training (MT) | Negative Affect/Withdrawal | 1.89 score on a scale | Standard Deviation 0.17 |
| Mindfulness Training Plus IE (MT+IE) | Negative Affect/Withdrawal | 2.06 score on a scale | Standard Deviation 0.27 |
Primary
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/.
Time frame: 1week+2days Post-Intervention Deprivation Contex
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Spatial Span | 5.17 number of correct trials | Standard Deviation 0.98 |
| Mindfulness Training (MT) | Spatial Span | 5.60 number of correct trials | Standard Deviation 0.55 |
| Mindfulness Training Plus IE (MT+IE) | Spatial Span | 4.50 number of correct trials | Standard Deviation 0.58 |
Primary
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/.
Time frame: 1-week Post-Intervention Smoking Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | Spatial Span | 5.17 number of correct trials | Standard Deviation 0.98 |
| Mindfulness Training (MT) | Spatial Span | 5.33 number of correct trials | Standard Deviation 0.52 |
| Mindfulness Training Plus IE (MT+IE) | Spatial Span | 5.20 number of correct trials | Standard Deviation 0.84 |
Secondary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | McKee Protocol Delay Until Smoking | 45.83 minutes | Standard Deviation 10.21 |
| Mindfulness Training (MT) | McKee Protocol Delay Until Smoking | 46.17 minutes | Standard Deviation 9.39 |
| Mindfulness Training Plus IE (MT+IE) | McKee Protocol Delay Until Smoking | 27.00 minutes | Standard Deviation 26.76 |
Secondary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wellness Education Control Condition | McKee Protocol Number of Cigarettes Smoked | 1.00 cigarettes | Standard Deviation 0 |
| Mindfulness Training (MT) | McKee Protocol Number of Cigarettes Smoked | 2.00 cigarettes | Standard Deviation 1.73 |
| Mindfulness Training Plus IE (MT+IE) | McKee Protocol Number of Cigarettes Smoked | 2.00 cigarettes | — |
Secondary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
Population: During administration of this assessment, there was equipment failure. For this reason, no participants had valid data collected or analyzed for this measure.
Secondary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
Population: During administration of this assessment, there was equipment failure. No participants had valid data collected or analyzed for this measure.
Secondary
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.
Time frame: 1week+2days Post-Intervention Deprivation Context
Population: During administration of this assessment, there was equipment failure. No participants had valid data collected or analyzed for this measure.