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This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.
All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Experimental | Participants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling. |
|
| Control Training | Placebo Comparator | Participants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training | Behavioral | The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. |
| Measure | Description | Time Frame |
|---|---|---|
| Point-prevalence Abstinence at End of Treatment | Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers. | End of treatment (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Point-prevalence Abstinence at 6-month Follow-up | Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers. |
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Inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Caryn Lerman, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28694338 | Derived | Kable JW, Caulfield MK, Falcone M, McConnell M, Bernardo L, Parthasarathi T, Cooper N, Ashare R, Audrain-McGovern J, Hornik R, Diefenbach P, Lee FJ, Lerman C. No Effect of Commercial Cognitive Training on Brain Activity, Choice Behavior, or Cognitive Performance. J Neurosci. 2017 Aug 2;37(31):7390-7402. doi: 10.1523/JNEUROSCI.2832-16.2017. Epub 2017 Jul 10. |
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Five hundred and fifty-seven participants provided consent and 213 were randomized. Reasons for exclusion from randomization included no home computer or internet access and failure to meet final eligibility criteria at the Intake Visit.
Recruitment for this clinical trial began in March 2011. Study accrual was completed in September 2015, with a final sample of N=213 in the intention-to-treat (ITT) analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Training | The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling. |
| FG001 | Control Training | The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Training | The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling. |
| BG001 | Control Training |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Point-prevalence Abstinence at End of Treatment | Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers. | Posted | Number | Percentage of participants | End of treatment (Week 12) |
|
AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous Cell Carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Squamous cell carcinoma was treated by surgical excision. The procedure was successful in removal of the Squamous Cell Carcinoma. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Albelda (Project Manager) | University of Pennsylvania (Perelman School of Medicine) | 2157467173 | albeldab@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Control training | Behavioral | The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. |
|
| 6 month follow-up |
| Cognitive Performance (Working Memory) | Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change. | Baseline and Week 12 (EOT) |
| Cognitive Performance (Response Inhibition) | Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word "PRESS" in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change. | Baseline and Week 12 (EOT) |
| Cognitive Performance (Attention) | Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change. | Baseline and Week 12 (EOT) |
The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cigarettes Per Day | Mean | Standard Deviation | cigarettes smoked per day |
|
| Fagerström Test for Nicotine Dependence Score | The Fagerström Test for Nicotine Dependence (FTND) will be administered; this is a 6-item measure of nicotine dependence which has good internal consistency and high test-retest reliability (r=.88). Scores may range from 0 to 9, with higher scores indicating greater nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Training | The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling. |
|
|
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| Secondary | Point-prevalence Abstinence at 6-month Follow-up | Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers. | Posted | Number | Percentage of participants | 6 month follow-up |
|
|
|
| Secondary | Cognitive Performance (Working Memory) | Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change. | Participants with performance >3SD from the mean at baseline were excluded as outliers. | Posted | Mean | Standard Deviation | Change in maximum recall span | Baseline and Week 12 (EOT) |
|
|
|
|
| Secondary | Cognitive Performance (Response Inhibition) | Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word "PRESS" in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change. | Participants with performance >3SD from the mean at baseline were excluded as outliers. | Posted | Mean | Standard Deviation | Change in number of commission errors | Baseline and Week 12 (EOT) |
|
|
|
|
| Secondary | Cognitive Performance (Attention) | Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change. | Participants with performance >3SD from the mean at Baseline were excluded as outliers. | Posted | Mean | Standard Deviation | Change in number of commission errors | Baseline and Week 12 (EOT) |
|
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|
| 6 |
| 108 |
| 42 |
| 108 |
| EG001 | Control Training | 3 | 105 | 54 | 105 |
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| Infection | Infections and infestations | Non-systematic Assessment | Ppt admitted to the hospital due to a severe infection at the site of a root canal. |
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| Pancreatitis | General disorders | Non-systematic Assessment |
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| Emergency Procedure | Surgical and medical procedures | Non-systematic Assessment | PPT complaining of chest/neck pain. PPT was dx with CAD and underwent an emergency procedure to implant 2 stents. |
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| Bowel Blockage | Gastrointestinal disorders | Non-systematic Assessment | Ppt was admitted to the hospital for treatment. |
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| Collapsed Lung | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Breast Cancer | Reproductive system and breast disorders | Non-systematic Assessment | PPT was dx. with Stage 4 Breast Cancer and underwent radiation tx. |
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| Surgery (Gastric Bypass) | Surgical and medical procedures | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Disturbing Dreams | Psychiatric disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |