Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03325777
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2017-10-25
Brief Title:
Approach Bias Retraining to Augment Smoking Cessation
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Approach Bias Retraining to Augment Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tobacco use is the most preventable cause of disease disability and death in the United States Standard smoking cessation care cognitive behavioral therapy and nicotine replacement therapy is effective in approximately 20 of the cases clearly indicating there is substantial room for improvement
Current work suggests that despite standard interventions continued substance abuse may result from addictive behaviors governed partly through automatic processes that exert their influence outside conscious control This is important from a treatment perspective as we should develop treatments to target implicit processes
Among a number of promising targets for intervention cognitive biases are important to address as they have been implicated as maintenance factors for addiction Approach bias defined as the automatically activated action tendency to approach smoking-related stimuli is a relatively novel cognitive bias and has been related to failed smoking cessation A recently developed task for approach bias assessment is the Approach Bias Retraining ABR a computerized joystick task increasingly used to measure automatic approach tendencies in addiction research
This clinical trial will evaluate a smoking cessation intervention that integrates standard care with approach bias retraining Results will provide novel information regarding the potential benefits of engaging implicit cognitive biases as a means to augment traditional smoking cessation therapy This study has the potential to help individuals attempting to quit smoking and ultimately provide unique information about the importance of targeting implicit processes to complement standard care
Current work suggests that despite standard interventions continued substance abuse may result from addictive behaviors governed partly through automatic processes that exert their influence outside conscious control This is important from a treatment perspective as we should develop treatments to target implicit processes
Among a number of promising targets for intervention cognitive biases are important to address as they have been implicated as maintenance factors for addiction Approach bias defined as the automatically activated action tendency to approach smoking-related stimuli is a relatively novel cognitive bias and has been related to failed smoking cessation A recently developed task for approach bias assessment is the Approach Bias Retraining ABR a computerized joystick task increasingly used to measure automatic approach tendencies in addiction research
This clinical trial will evaluate a smoking cessation intervention that integrates standard care with approach bias retraining Results will provide novel information regarding the potential benefits of engaging implicit cognitive biases as a means to augment traditional smoking cessation therapy This study has the potential to help individuals attempting to quit smoking and ultimately provide unique information about the importance of targeting implicit processes to complement standard care
Detailed Description:
The integrated intervention involves seven weekly 60-minute therapy sessions The each therapy session involves 15 minutes of computerized approach bias retraining and 45 minutes of individual cognitive behavioral therapy In order to maximize adherence the scheduling of session visits will be individualized to each participants schedule
During the first therapy session the study therapist will collect relevant smoking assessments and begin orienting the participant to the joystick procedures The therapist will explain that the joystick task is thought to affect your automatic tendencies to approach or avoid cigarettes At this time the participant will complete the first session of approach bias retraining
Participants will begin therapy sessions 2-6 by completing the computerized approach bias retraining task At session 2 the therapist will then congratulate participants for deciding to quit smoking review the positive health consequences of quitting and express their willingness to help the participant succeed Participants past quit attempts will be reviewed to identify what strategies contributed to success and what factors hindered their previous attempts and a target quit date will be set for week 6 Lastly participants will initiate self-monitoring or track each cigarette they smoke through Quit date and note situational cues for smoking eg times of the day activities while smoking
During therapy sessions 2-5 the therapists will then assist participants in anticipating situations in their lives that will likely place them at risk for relapse prepare them for the possibility of lapsing and provide strategies for coping with the potential negative emotional reactions to lapsing In addition therapists will advise all participants to avoid or reduce drinking and advise all participants to tell their friends and family about their quit date and will discuss ways to increase social support during the quit attempt Lastly therapists will instruct participants in the proper use of the nicotine patch eg placement of patch use one a day importance of not smoking while using the patch and help them prepare for the quit day eg removing all tobacco products from their environment
At session 6 participants will initiate a quit attempt Therapists will provide individual support for participants during this early period of abstinence This contact will provide the opportunity for more tailored and elaborate discussions of quitting experiences and coping strategies for anticipated high-risk situations Therapists will also reinforce success and provide support and encouragement for participants who slip and smoke and ask participants to anticipate potential challenges to remaining abstinent from smoking and discuss strategies for coping with those situations In addition during this session therapists will ask participants to discuss social supports for nonsmoking help to develop strategies for maximizing social support systems and develop participants skills in requesting behavioral changes from others Beginning week 6 participants will be instructed to apply one patch daily Participants will use the full strength 21-mg patch for 6 weeks and then be instructed to taper to the 14-mg patch for the next 1 week and then to the 7-mg patch for the remaining 1 week
Session 7 will be the last day that the ABR task is administered This session will focus primarily on relapse prevention Therapists will continue with relapse prevention tactics including provision of social support avoiding high-risk situations using social support from friendsco-workers and maintaining non-smoking lifestyle changes
Participants will be asked to come in for a brief follow-up visit at week 9 1- month week 10 2-month week 14 and 3-month week 18 The primary function of these visits is to gather information about the participants smoking habits post treatment
During the first therapy session the study therapist will collect relevant smoking assessments and begin orienting the participant to the joystick procedures The therapist will explain that the joystick task is thought to affect your automatic tendencies to approach or avoid cigarettes At this time the participant will complete the first session of approach bias retraining
Participants will begin therapy sessions 2-6 by completing the computerized approach bias retraining task At session 2 the therapist will then congratulate participants for deciding to quit smoking review the positive health consequences of quitting and express their willingness to help the participant succeed Participants past quit attempts will be reviewed to identify what strategies contributed to success and what factors hindered their previous attempts and a target quit date will be set for week 6 Lastly participants will initiate self-monitoring or track each cigarette they smoke through Quit date and note situational cues for smoking eg times of the day activities while smoking
During therapy sessions 2-5 the therapists will then assist participants in anticipating situations in their lives that will likely place them at risk for relapse prepare them for the possibility of lapsing and provide strategies for coping with the potential negative emotional reactions to lapsing In addition therapists will advise all participants to avoid or reduce drinking and advise all participants to tell their friends and family about their quit date and will discuss ways to increase social support during the quit attempt Lastly therapists will instruct participants in the proper use of the nicotine patch eg placement of patch use one a day importance of not smoking while using the patch and help them prepare for the quit day eg removing all tobacco products from their environment
At session 6 participants will initiate a quit attempt Therapists will provide individual support for participants during this early period of abstinence This contact will provide the opportunity for more tailored and elaborate discussions of quitting experiences and coping strategies for anticipated high-risk situations Therapists will also reinforce success and provide support and encouragement for participants who slip and smoke and ask participants to anticipate potential challenges to remaining abstinent from smoking and discuss strategies for coping with those situations In addition during this session therapists will ask participants to discuss social supports for nonsmoking help to develop strategies for maximizing social support systems and develop participants skills in requesting behavioral changes from others Beginning week 6 participants will be instructed to apply one patch daily Participants will use the full strength 21-mg patch for 6 weeks and then be instructed to taper to the 14-mg patch for the next 1 week and then to the 7-mg patch for the remaining 1 week
Session 7 will be the last day that the ABR task is administered This session will focus primarily on relapse prevention Therapists will continue with relapse prevention tactics including provision of social support avoiding high-risk situations using social support from friendsco-workers and maintaining non-smoking lifestyle changes
Participants will be asked to come in for a brief follow-up visit at week 9 1- month week 10 2-month week 14 and 3-month week 18 The primary function of these visits is to gather information about the participants smoking habits post treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None