Tobacco Smoking Clinical Trial
— DOANOfficial title:
Rescuing Cognitive and Emotional Regulatory Processes to Aid Smoking Prevention
Verified date | July 2021 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the current proposal is to investigate the extent to which interventions designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory processes enhance the effectiveness of standard no-smoking informational interventions. Emotional and cognitive dysregulation increases the likelihood of smoking and makes it particularly challenging to benefit from standard interventions. Working memory and associated deficits make it more difficult for individuals to utilize information from interventions, make judicious decisions regarding the cost and benefits of smoking, and to resist targeted advertising. In addition, disruptions in emotion regulatory capacities increase the probability of using cigarettes as a coping mechanism to self-regulate negative affect and stress. Individuals with affective disturbances smoke at higher rates and have more difficulties quitting, and are more likely to smoke as a way to reduce negative affect. The goal of the current project is to generate new insights and new approaches to smoking prevention among low-SES youth by investigating (1) the influence of known SES-related deficits in working memory and affect regulation on proximal measures of smoking risk, and (2) the potential for targeted interventions to reverse these risks. Specifically, the investigators examine the influence of working memory training and distress tolerance (mindfulness) interventions on cognitive/affective targets placing individuals at risk for smoking initiation and maintenance. The specific aims of this study are therefore to investigate: 1. The feasibility and acceptability of school- and community-based brief interventions targeting working memory and distress tolerance in a diverse sample of low SES adolescents. 2. The effects of working memory and distress tolerance interventions, relative to a standard informational intervention alone, on specific cognitive-affective targets-delay discounting and distress tolerance--relevant to cigarette smoking initiation and maintenance. 3. The impact of cognitive /affective target activation on proximal measures of smoking risk/behavior and related health outcomes following intervention.
Status | Completed |
Enrollment | 124 |
Est. completion date | April 4, 2019 |
Est. primary completion date | April 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 16 Years |
Eligibility | Inclusion Criteria: - Adolescents (ages 12 years or older) enrolled in high school as a freshman or sophomore. - Reflecting the demographics of the community in which we are recruiting, we expect approximately 70% of the sample to be at or below the poverty level, balanced between males and females, with the majority from an ethnic minority background. Exclusion Criteria: - Non-English speaking (operationalized as the inability to read and understand the consent form and converse in spoken English) |
Country | Name | City | State |
---|---|---|---|
United States | Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | Claremont McKenna College, National Institute on Drug Abuse (NIDA), Southern Methodist University, University of Houston, Virginia Polytechnic Institute and State University |
United States,
Otto MW, Gorlin EI, Rosenfield D, Patten EA, Bickel WK, Zvolensky MJ, Doan SN. Rescuing cognitive and emotional regulatory skills to aid smoking prevention in at-risk youth: A randomized trial. Contemp Clin Trials. 2018 Jul;70:1-7. doi: 10.1016/j.cct.2018.04.005. Epub 2018 Apr 12. — View Citation
Otto MW, Rosenfield D, Gorlin EI, Hoyt DL, Patten EA, Bickel WK, Zvolensky MJ, Doan SN. Targeting cognitive and emotional regulatory skills for smoking prevention in low-SES youth: A randomized trial of mindfulness and working memory interventions. Addict Behav. 2020 May;104:106262. doi: 10.1016/j.addbeh.2019.106262. Epub 2019 Dec 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions | Feasibility/acceptability of each intervention (indexed by attendance of at least 80% of interventions by 70% of the randomized sample) will be assessed. | Intervention (week 1 to week 8) | |
Primary | Specific Aim 2: Working Memory Capacity | Assessment includes three computer-administered WM performance measures (N-back, Auditory Digit Span, and Corsi Block Tapping task) which are z-scored and aggregated to create a single WM index.The Working Memory Capacity Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater capacity. | 1 Week | |
Primary | Specific Aim 2: Distress Tolerance | Distress Tolerance (DT) assessment includes the Distress Intolerance Index (DII) and the computerized Mirror-Tracing Persistence Task (MTPT-C) which are z-scored and aggregated to form a single DT index.The Distress Tolerance Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and with higher scores reflecting worse tolerance. | 1 Week | |
Primary | Specific Aim 3: Smoking Risk (Standard Smoking Assessment) | The Standard Smoking Assessment is one of 3 assessments of smoking risk along with the B-IAT and the Delay Discounting task. Reported here are the results from the SSA, a 5-item scale asking about attitudes and likelihood of smoking with total scores ranging from 0 (no susceptibility) to 11 (highest susceptibility). The natural log of these scores are reported, with higher scores indicating higher susceptibility. | 1 Week | |
Primary | Specific Aim 3: Smoking Risk (B-IAT) | The brief Implicit Attitudes Test is one of 3 assessments of smoking risk along with the Delay Discounting task and the SSA. Reported here are the d-scores from the B-IAT task. Participants sorted stimuli into "positive" or "negative" categories in 4 blocks--2 of which included "Smoking" and "I feel positive," the other 2 including "Smoking" and "I feel negative." Shorter response times when sorting "Smoking--Positive" versus "Smoking--Negative" blocks indicate implicit tendency to associate "smoking" with "positive." Standardized difference scores (d-scores) were computed using the improved scoring algorithm recommended by prior research (Greenwald, Banaji, & Nosek, 2003). Higher d-scores indicate less positive implicit attitudes towards smoking. | 1 Week | |
Primary | Specific Aim 3: Smoking Risk (Delay Discounting Task) | The Delay Discounting task is one of 3 assessments of smoking risk along with the B-IAT and SSA. It includes a series of computerized decisions in which participants select a money award immediately or a larger award in 7, 14, or 30 days time. Participants were notified that they would be paid the amount selected on one randomly selected trial. K-values were submitted for analyses with higher scores representing great discounting of delayed rewards, meaning that higher scores reflect greater tendency to select the immediate award. Natural logs of K-values were used if K-values showed a large amount of skew. Reported here are the natural logs of k-values from the delay discounting task. Natural logs are used to reduce skew of k-values. | 1 Week | |
Primary | Specific Aim 4: Actual Smoking Status | The piCO Smokerlyzer is a tool used to assess amount of carbon monoxide exhaled by a participant, with scores ranging from 0 to 150 parts per million (PPM), with scores under 3 indicating non-smoking and scores over 36 indicating very heavy addiction. The Timeline Follow Back is a self-report measure in which participants report the amount of cigarettes smoked each day for the last month. Mean proportions of smokers are reported (0=no smoking, 1=smoking) with smoking behaviors assessed via the piCO Smokerlyzer and the Timeline Follow Back. | 1 Week |
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