Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation

NCT03565497 | Terminated Results

• 1 other identifier: DA046963
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims for this Project Are:

1. 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.
2. 2.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.
3. 3.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.
4. 4.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.
5. 5.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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (14)

• 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.

  1-week Post-Intervention Smoking Context

• Negative Affect/Withdrawal

  Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.

  1-week Post-Intervention Smoking Context

• N-Back Task

  Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.

  1-week Post-Intervention Smoking Context

• Spatial Span

  The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.

  1-week Post-Intervention Smoking Context

• Digit Span

  The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.

  1-week Post-Intervention Smoking Context

• Anxiety Sensitivity

  The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.

  1-week Post-Intervention Smoking Context

• Mirror-Tracing Persistence Task

  The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.

  1-week Post-Intervention Smoking Context

• Negative Affect

  PANAS-State Negative was used to assess the mechanistic outcome of Negative Affectivity/Stress. Items from the negative subscale are summed to create a total score. Scores can range from 10-50, with lower scores representing lower levels of negative affect.

  1week+2days Post-Intervention Deprivation Context

• Negative Affect/Withdrawal

  Wisconsin Smoking Withdrawal Scale (WSWS) was used to assess withdrawal symptoms. Some items are reversed scored and the average of all items is calculated. Scores range between 0 and 4, with higher scores indicating stronger withdrawal symptoms.

  1week+2days Post-Intervention Deprivation Context

• N-Back Task

  Adaptive N-Back task is a continuous performance task that was administered on the computer. It was used to assess working memory capacity. The participant is present with a series of stimuli and asked to identify when the current stimulus matches the one from n back steps prior. For the current task, n was equal to 2. As such, the score reported is the total number of correct trials form the 2-back condition of the computer task. Higher scores indicate better working memory capacity. Participant completed 20 trials. The task was administered online and can be found at: https://measures.scienceofbehaviorchange.org/measuredetails/d4a117c9-e5d8-41a0-8227-ac570a60f89f.

  1week+2days Post-Intervention Deprivation Contex

• Spatial Span

  The mechanistic outcome of working memory was assessed by summing the number of correct trials on the backwards spatial span task. The spatial span task was administered via computer. On each trial, participants see an array of geometric shapes (white squares) on the screen. The squares change from white to a different color in a sequence with variable orders and colors. At the end of the list sequences, the participants attempt to recall the squares in the reverse order that they changed color. The difficulty on each trial is increased by varying the number of boxes from two (easiest) to nine (hardest). The maximum number of boxes correctly recalled is the outcome measure. Higher numbers of boxes recalled indicates increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/spatial-span-task/.

  1week+2days Post-Intervention Deprivation Contex

• Digit Span

  The mechanistic outcome of working memory was assessed by taking the longest span of correct answers on the backwards digit span task. The digit span task was administered via computer. On each trial, participants are presented with lists of digits 1 at a time on the screen. At the end of each list, participants attempt to recall the digits in reverse ordered they appeared by typing them in. After each successfully completed trial, the number of digits in the list is increased by 1 for the next trial. After a failed trial, the number of digits remains the same for the next trial. The task ends when the participant makes errors for two trails in a row for a given digit span. The maximum number of digits correctly recalled is the outcome measure. Higher numbers (more digits) indicated increased working memory capacity. The task was administered online from the SOBC Repository and is available at: https://scienceofbehaviorchange.org/measures/digit-span-task/.

  1week+2days Post-Intervention Deprivation Context

• Anxiety Sensitivity

  The mechanistic outcome of distress tolerance was assessed with the Anxiety Sensitivity Index (ASI 3). Items on this scale are summed, with scores ranging from 0-72. Higher scores indicate worse outcome.

  1week+2days Post-Intervention Deprivation Contex

• Mirror-Tracing Persistence Task

  The mechanistic outcome of behavioral distress tolerance was assessed with the mirror-tracing persistence task. The task measures how long the participant persists in completing the tracing tasks. Longer times are indicative of better behavioral stress tolerance capacity.

  1week+2days Post-Intervention Deprivation Context

Secondary Outcomes (5)

• McKee Protocol Delay Until Smoking

  1week+2days Post-Intervention Deprivation Context

• McKee Protocol Number of Cigarettes Smoked

  1week+2days Post-Intervention Deprivation Context

• Smoking Topography-1

  1week+2days Post-Intervention Deprivation Context

• Smoking Topography-2

  1week+2days Post-Intervention Deprivation Context

• Smoking Topography-3

  1week+2days Post-Intervention Deprivation Context

Study Arms (3)

Wellness Education Control Condition

PLACEBO COMPARATOR

The wellness education control condition (CC) is modeled after that used in our studies of exercise for smoking cessation, but delivered in an individual format. Content focuses on discussions of a variety of healthy lifestyle topics, such as healthy eating, time management, recommended health screenings, and cancer and cardiovascular prevention. Content is delivered using a combination of lectures, videos, handouts, and discussions while allowing participants to set their own realistic wellness goals, which they can gradually incorporate into their lives.

Behavioral: Wellness Education Control Condition

Mindfulness Training (MT)

EXPERIMENTAL

Mindfulness training will be adapted for 6 individual sessions;elements include: (1) a body scan designed to teach participants to pay attention to specific parts of their bodies as a strategy to increase attentional capacities/reduce habitual mind-wandering; (2) non-judgmental awareness, and (3) 'awareness of breath' meditation, with an additional focus on helping participants become more aware of the present moment and refrain from habitually engaging in self-related pre-occupations concerning the future or the past.

Behavioral: Mindfulness Training

Mindfulness Training Plus IE (MT+IE)

EXPERIMENTAL

This condition will mirror the MT condition for the first 4 individual sessions, then for the final 2 individual sessions, MT will be rehearsed under conditions of sensations of anxiety/tension induced by interoceptive exposure procedures (IE).

Behavioral: Mindfulness Training Plus IE

Interventions

Wellness Education Control Condition BEHAVIORAL

As per arm of the same name

Wellness Education Control Condition

Mindfulness Training BEHAVIORAL

As per arm of the same name

Mindfulness Training (MT)

Mindfulness Training Plus IE BEHAVIORAL

As per arm of the same name

Mindfulness Training Plus IE (MT+IE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Otto MW, Zvolensky MJ, Rosenfield D, Hoyt DL, Witkiewitz K, McKee SA, Bickel WK, Smits JAJ. A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults. Health Psychol. 2020 Sep;39(9):815-825. doi: 10.1037/hea0000858.

  PMID: 32833483 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Early termination of the study due to the COVID-19 shut down of human subjects research led to a small number of participants enrolled in the study and analyzed.

Results Point of Contact

• Title: Dr. Michael Otto
• Organization: Boston University

mwotto@bu.edu

617-306-1836

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: April 19, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within one year of completion (publication) of the primary Aims for this project,

Locations

US (1)