Trial Outcomes & Findings for Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation (NCT NCT03565497)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1-week Post-Intervention Smoking Context

Results posted on

2023-05-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	8	8	8
Overall Study V1	8	7	7
Overall Study V2	8	7	5
Overall Study V3	6	6	5
Overall Study V4	6	6	5
Overall Study V5	6	6	5
Overall Study V6	6	6	5
Overall Study SSA	6	6	5
Overall Study DWA	6	5	4
Overall Study PFU	6	5	4
Overall Study COMPLETED	6	5	4
Overall Study NOT COMPLETED	2	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
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

Age was calculated from date of birth. One participant in the Mindfulness + IE listed the date of their study visit as DOB, and therefore, we were unable to calculate age.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Negative Affect	11.33 score on a scale Standard Deviation 1.21	12.67 score on a scale Standard Deviation 3.56	24.20 score on a scale Standard Deviation 9.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Negative Affect/Withdrawal	1.81 score on a scale Standard Deviation 0.61	1.84 score on a scale Standard Deviation 0.19	2.24 score on a scale Standard Deviation 0.46

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
N-Back Task	113.00 score Standard Deviation 84.43	63.17 score Standard Deviation 53.11	69.00 score Standard Deviation 101.16

PRIMARY outcome

Timeframe: 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/.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Spatial Span	5.17 number of correct trials Standard Deviation 0.98	5.33 number of correct trials Standard Deviation 0.52	5.20 number of correct trials Standard Deviation 0.84

PRIMARY outcome

Timeframe: 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/.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Digit Span	5.83 longest span of correct answers Standard Deviation 0.41	5.33 longest span of correct answers Standard Deviation 2.06	4.20 longest span of correct answers Standard Deviation 1.30

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Anxiety Sensitivity	8.00 score on a scale Standard Deviation 12.96	13.67 score on a scale Standard Deviation 10.41	22.20 score on a scale Standard Deviation 9.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=5 Participants 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
Mirror-Tracing Persistence Task	93.31 seconds Standard Deviation 68.86	255.85 seconds Standard Deviation 291.89	136.11 seconds Standard Deviation 112.22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Negative Affect	10.33 score on a scale Standard Deviation 0.82	14.40 score on a scale Standard Deviation 6.12	21.25 score on a scale Standard Deviation 6.40

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Negative Affect/Withdrawal	1.73 score on a scale Standard Deviation 0.67	1.89 score on a scale Standard Deviation 0.17	2.06 score on a scale Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
N-Back Task	103.33 score Standard Deviation 99.49	75.20 score Standard Deviation 52.79	11.50 score Standard Deviation 8.96

PRIMARY outcome

Timeframe: 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/.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Spatial Span	5.17 number of correct trials Standard Deviation 0.98	5.60 number of correct trials Standard Deviation 0.55	4.50 number of correct trials Standard Deviation 0.58

PRIMARY outcome

Timeframe: 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/.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Digit Span	6.33 longest span of correct answers Standard Deviation 1.03	5.60 longest span of correct answers Standard Deviation 1.82	4.25 longest span of correct answers Standard Deviation 0.96

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Anxiety Sensitivity	6.67 score on a scale Standard Deviation 10.63	14.40 score on a scale Standard Deviation 11.76	17.50 score on a scale Standard Deviation 19.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=5 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
Mirror-Tracing Persistence Task	65.67 seconds Standard Deviation 39.35	137.83 seconds Standard Deviation 64.43	47.91 seconds Standard Deviation 55.49

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=6 Participants 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	Mindfulness Training (MT) n=6 Participants 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	Mindfulness Training Plus IE (MT+IE) n=4 Participants 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
McKee Protocol Delay Until Smoking	45.83 minutes Standard Deviation 10.21	46.17 minutes Standard Deviation 9.39	27.00 minutes Standard Deviation 26.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wellness Education Control Condition n=3 Participants 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	Mindfulness Training (MT) n=3 Participants 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	Mindfulness Training Plus IE (MT+IE) n=1 Participants 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
McKee Protocol Number of Cigarettes Smoked	1.00 cigarettes Standard Deviation 0.00	2.00 cigarettes Standard Deviation 1.73	2.00 cigarettes Standard Deviation NA Data was only collected on one participant, therefore a standard deviation cannot be calculated.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Wellness Education Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mindfulness Training (MT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mindfulness Training Plus IE (MT+IE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Otto

Boston University

Phone: 617-306-1836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Wellness Education Control Condition n=8 Participants 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	Mindfulness Training (MT) n=8 Participants 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	Mindfulness Training Plus IE (MT+IE) n=8 Participants 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	Total n=24 Participants Total of all reporting groups
Age, Continuous	49.56 years STANDARD_DEVIATION 8.31 • n=8 Participants • Age was calculated from date of birth. One participant in the Mindfulness + IE listed the date of their study visit as DOB, and therefore, we were unable to calculate age.	45.63 years STANDARD_DEVIATION 13.59 • n=8 Participants • Age was calculated from date of birth. One participant in the Mindfulness + IE listed the date of their study visit as DOB, and therefore, we were unable to calculate age.	47.14 years STANDARD_DEVIATION 10.92 • n=7 Participants • Age was calculated from date of birth. One participant in the Mindfulness + IE listed the date of their study visit as DOB, and therefore, we were unable to calculate age.	47.46 years STANDARD_DEVIATION 10.77 • n=23 Participants • Age was calculated from date of birth. One participant in the Mindfulness + IE listed the date of their study visit as DOB, and therefore, we were unable to calculate age.
Sex/Gender, Customized Reported Gender · Male	6 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	17 Participants n=24 Participants
Sex/Gender, Customized Reported Gender · Female	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants
Sex/Gender, Customized Reported Gender · Transgender	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=8 Participants	7 Participants n=8 Participants	6 Participants n=8 Participants	19 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	4 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=8 Participants	13 Participants n=24 Participants
Race (NIH/OMB) White	3 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants
Region of Enrollment United States	8 Participants n=8 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	24 Participants n=24 Participants
Fagerstrom Test for Nicotine Dependence (FTND)	3.13 units on a scale STANDARD_DEVIATION 1.73 • n=8 Participants	4.37 units on a scale STANDARD_DEVIATION 2.77 • n=8 Participants	5.13 units on a scale STANDARD_DEVIATION 1.13 • n=8 Participants	4.21 units on a scale STANDARD_DEVIATION 2.08 • n=24 Participants
Smoking Urges (QSU)	36.75 units on a scale STANDARD_DEVIATION 14.97 • n=8 Participants	36.75 units on a scale STANDARD_DEVIATION 14.72 • n=8 Participants	38.75 units on a scale STANDARD_DEVIATION 13.38 • n=8 Participants	37.42 units on a scale STANDARD_DEVIATION 15.79 • n=24 Participants
Executive Function (BRIEF A)	91.63 units on a scale STANDARD_DEVIATION 16.19 • n=8 Participants	101.12 units on a scale STANDARD_DEVIATION 27.72 • n=8 Participants	111.75 units on a scale STANDARD_DEVIATION 26.03 • n=8 Participants	101.50 units on a scale STANDARD_DEVIATION 24.29 • n=24 Participants
Psychological Distress (Kessler K6+)	2.00 units on a scale STANDARD_DEVIATION 2.00 • n=8 Participants	5.13 units on a scale STANDARD_DEVIATION 4.55 • n=8 Participants	9.00 units on a scale STANDARD_DEVIATION 6.70 • n=8 Participants	5.38 units on a scale STANDARD_DEVIATION 5.45 • n=24 Participants