Cognitive Training for Nicotine Dependence

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Nicotine Addiction
• Interventions: Behavioral: Control training; Behavioral: Cognitive Training

• Registration Number: NCT01252966
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Study Start: 2011-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-09-07
• Results First Submitted QC: 2016-11-04
• Status Verified: 2017-01
• Results First Posted: 2017-01-02
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Training	Control training	Participants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling
Cognitive Training	Cognitive Training	Participants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling.

Primary Outcome Measures

Name	Time	Method
Point-prevalence Abstinence at End of Treatment	End of treatment (Week 12)	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.

Secondary Outcome Measures

Name	Time	Method
Point-prevalence Abstinence at 6-month Follow-up	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.
Cognitive Performance (Working Memory)	Baseline and Week 12 (EOT)	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.
Cognitive Performance (Response Inhibition)	Baseline and Week 12 (EOT)	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.
Cognitive Performance (Attention)	Baseline and Week 12 (EOT)	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.

Trial Locations

Locations (1)

Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States