NCT03565497

Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation

Terminated NA Results posted Last updated 17 May 2023

What this trial tests

NA trial testing Wellness Education Control Condition in Smoking Cessation in 30 participants. Terminated before completion.

Timeline

19 April 2019

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	Boston University Charles River Campus
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	19 April 2019
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Wellness Education Control Condition
• Mindfulness Training
• Mindfulness Training Plus IE

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Boston University Charles River Campus

Who can join

Adults 18 to 65, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Negative Affect Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	11.33	± 1.21
Mindfulness Training (MT)	12.67	± 3.56
Mindfulness Training Plus IE (MT+IE)	24.20	± 9.18

Negative Affect/Withdrawal Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	1.81	± 0.61
Mindfulness Training (MT)	1.84	± 0.19
Mindfulness Training Plus IE (MT+IE)	2.24	± 0.46

N-Back Task Primary · 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.scienc

Group	Value	95% CI
Wellness Education Control Condition	113.00	± 84.43
Mindfulness Training (MT)	63.17	± 53.11
Mindfulness Training Plus IE (MT+IE)	69.00	± 101.16

Spatial Span Primary · 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

Group	Value	95% CI
Wellness Education Control Condition	5.17	± 0.98
Mindfulness Training (MT)	5.33	± 0.52
Mindfulness Training Plus IE (MT+IE)	5.20	± 0.84

Digit Span Primary · 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

Group	Value	95% CI
Wellness Education Control Condition	5.83	± 0.41
Mindfulness Training (MT)	5.33	± 2.06
Mindfulness Training Plus IE (MT+IE)	4.20	± 1.30

Anxiety Sensitivity Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	8.00	± 12.96
Mindfulness Training (MT)	13.67	± 10.41
Mindfulness Training Plus IE (MT+IE)	22.20	± 9.18

Mirror-Tracing Persistence Task Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	93.31	± 68.86
Mindfulness Training (MT)	255.85	± 291.89
Mindfulness Training Plus IE (MT+IE)	136.11	± 112.22

Negative Affect Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	10.33	± 0.82
Mindfulness Training (MT)	14.40	± 6.12
Mindfulness Training Plus IE (MT+IE)	21.25	± 6.40

Negative Affect/Withdrawal Primary · 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.

Group	Value	95% CI
Wellness Education Control Condition	1.73	± 0.67
Mindfulness Training (MT)	1.89	± 0.17
Mindfulness Training Plus IE (MT+IE)	2.06	± 0.27

N-Back Task Primary · 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.scienc

Group	Value	95% CI
Wellness Education Control Condition	103.33	± 99.49
Mindfulness Training (MT)	75.20	± 52.79
Mindfulness Training Plus IE (MT+IE)	11.50	± 8.96

Spatial Span Primary · 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

Group	Value	95% CI
Wellness Education Control Condition	5.17	± 0.98
Mindfulness Training (MT)	5.60	± 0.55
Mindfulness Training Plus IE (MT+IE)	4.50	± 0.58

Digit Span Primary · 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

Group	Value	95% CI
Wellness Education Control Condition	6.33	± 1.03
Mindfulness Training (MT)	5.60	± 1.82
Mindfulness Training Plus IE (MT+IE)	4.25	± 0.96

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults.
   Otto MW, Zvolensky MJ, Rosenfield D, Hoyt DL, et al · · 2020 · cited 9× · PMID 32833483 · DOI 10.1037/hea0000858