Trial Outcomes & Findings for Perinatal Attentional Retraining Intervention for Smoking for Minority Women (NCT NCT04114877)

NCT ID: NCT04114877

Last Updated: 2025-03-18

Results Overview

Attentional bias (AB) is assessed using the standard (unmodified) visual probe (VP) task on the smartphone and study visits, and measured by the reaction time (RT) in milliseconds, i.e. the time it takes a participant to identify the location of the probe after presentation of the stimulus. The AB scores will be computed as the difference in RTs on trials where the probe replaced the smoking picture vs. trials where the probe replaced the neutral picture. The VP task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

end of phase 2, up to 3 months

Results posted on

2025-03-18

Participant Flow

Participant milestones

Participant milestones
Measure
Attentional Retraining (AR)
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Overall Study
STARTED
13
9
Overall Study
COMPLETED
13
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perinatal Attentional Retraining Intervention for Smoking for Minority Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Attentional Retraining (AR)
n=13 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=9 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Total
n=22 Participants
Total of all reporting groups
Age, Customized
>30 years
10 Participants
n=99 Participants
4 Participants
n=107 Participants
14 Participants
n=206 Participants
Age, Customized
≤30 years
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
Sex: Female, Male
Female
13 Participants
n=99 Participants
9 Participants
n=107 Participants
22 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic, White
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic, Black
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Race/Ethnicity, Customized
Black, non-Hispanic
8 Participants
n=99 Participants
6 Participants
n=107 Participants
14 Participants
n=206 Participants
Race/Ethnicity, Customized
>1 Race, non-Hispanic
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
13 participants
n=99 Participants
9 participants
n=107 Participants
22 participants
n=206 Participants
Education
< High school degree
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Education
High school degree
5 Participants
n=99 Participants
2 Participants
n=107 Participants
7 Participants
n=206 Participants
Education
Some college (no degree)
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
Education
Associate's degree
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Education
Refuse to Answer
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Pre-quit smoking level
≤10 cigarettes/day
11 Participants
n=99 Participants
5 Participants
n=107 Participants
16 Participants
n=206 Participants
Pre-quit smoking level
>10 cigarettes/day
2 Participants
n=99 Participants
4 Participants
n=107 Participants
6 Participants
n=206 Participants
Anxiety
Yes
4 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
Anxiety
No
9 Participants
n=99 Participants
4 Participants
n=107 Participants
13 Participants
n=206 Participants
Age started smoking (years)
15.8 years
STANDARD_DEVIATION 3.2 • n=99 Participants
15.9 years
STANDARD_DEVIATION 1.5 • n=107 Participants
15.8 years
STANDARD_DEVIATION 2.6 • n=206 Participants

PRIMARY outcome

Timeframe: end of phase 2, up to 3 months

Population: While 13 participants were randomized to AR and 9 to the control VP task, only 10 and 4 participants, respectively, provided sufficient data to be included in the analysis.

Attentional bias (AB) is assessed using the standard (unmodified) visual probe (VP) task on the smartphone and study visits, and measured by the reaction time (RT) in milliseconds, i.e. the time it takes a participant to identify the location of the probe after presentation of the stimulus. The AB scores will be computed as the difference in RTs on trials where the probe replaced the smoking picture vs. trials where the probe replaced the neutral picture. The VP task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe.

Outcome measures

Outcome measures
Measure
Attentional Retraining (AR)
n=10 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=4 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Attentional Bias- Smoking Related Stimuli
-44.0 milliseconds
Standard Deviation 170.9
37.9 milliseconds
Standard Deviation 163.6

PRIMARY outcome

Timeframe: end of phase 2, up to 3 months

Population: While 13 participants were randomized to AR and 9 to the control VP task, only 10 and 4 participants, respectively, provided sufficient data to be included in the analysis.

Attentional bias (AB) is assessed using the standard (unmodified) visual probe (VP) task on the smartphone and at study visits, and measured by the reaction time (RT) in milliseconds, i.e. the time it takes a participant to identify the location of the probe after presentation of the stimulus. The AB scores will be computed as the difference in RTs on trials where the probe replaced the stress-related word vs. trials where the probe replaced the neutral word. The VP task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe.

Outcome measures

Outcome measures
Measure
Attentional Retraining (AR)
n=10 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=4 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Attentional Bias Toward Stressrelated Stimuli
-12.1 milliseconds
Standard Deviation 130.6
-46.5 milliseconds
Standard Deviation 94.8

SECONDARY outcome

Timeframe: end of phase 2, up to 3 months

Population: While 13 participants were randomized to AR and 9 to the control VP task, only 10 and 4 participants, respectively, provided sufficient data to be included in the analysis.

Self-reported craving is a single item used to assesses craving for cigarettes ("I have strong urges to smoke a cigarette") on a 7-point Likert scale (1 = Strongly Disagree, 7 = Strongly Agree) in the daily assessments delivered on the smartphone and at study visits. Higher scores on the 7-point Likert scale are indicative of higher cravings for cigarettes, with a 7 indicating high craving for a cigarette and 1 indicating low craving for a cigarette. This scale is a subjective measure of a participant's craving for cigarettes developed by the researchers and utilized in prior research.

Outcome measures

Outcome measures
Measure
Attentional Retraining (AR)
n=10 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=4 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Self-reported Craving
1.35 score on 7-point Likert scale
Standard Deviation 0.89
1.66 score on 7-point Likert scale
Standard Deviation 1.82

SECONDARY outcome

Timeframe: end of phase 2, up to 3 months

Population: While 13 participants were randomized to AR and 9 to the control VP task, only 10 and 4 participants, respectively, provided sufficient data to be included in the analysis.

Self-reported stress was assessed using four items: three adapted from the Parenting Stress Index (I feel I can't handle things; I feel trapped by parenting; I feel overwhelmed by trying to meet my baby's needs) and one item developed for the study (since the last assessment my baby has been difficult to console). Participants responded to the four items on 7-point Likert-type scales (1 = Strongly Disagree, 7 = Strongly Agree) in the daily assessments delivered on the smartphone and at study visits. The mean score was computed. Higher scores on the scale are indicative of high stress levels and low scores of low stress levels.

Outcome measures

Outcome measures
Measure
Attentional Retraining (AR)
n=10 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=4 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Self-reported Stress
3.34 score on a scale
Standard Deviation 0.77
3.57 score on a scale
Standard Deviation 0.70

SECONDARY outcome

Timeframe: from randomization to 6-month follow-up, up to 8 months

Population: While 13 participants were randomized to AR and 9 to the control VP task, only 8 and 4 participants, respectively, provided sufficient data to be included in the analysis.

Relapse is defined as any smoking on 7 consecutive days or smoking at least once each week over 2 consecutive weeks. Smoking history is collected with the timeline follow-back at each study visit. This is a binary yes/no outcome. Presented here is the number of participants who relapsed to smoking.

Outcome measures

Outcome measures
Measure
Attentional Retraining (AR)
n=8 Participants
Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. Attentional retraining (AR) is the most commonly used CBM intervention in the study of addiction-related attentional bias. Attentional retraining (AR): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
Visual Probe (VP)
n=4 Participants
The visual probe (VP) task can measure attentional bias for drug-related cues. Visual probe (VP): The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Smoking Relapse
4 Participants
2 Participants

Adverse Events

Attentional Retraining (AR)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Visual Probe (VP)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ariadna Forray

Yale School of Medicine

Phone: 2037648620

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place