An interventional study of Attentional retraining (AR) and Visual probe (VP) in Postpartum Smoking Relapse, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
The proposed research intends to randomize 50 abstinent pregnant Black or Hispanic smokers to receive either the attentional retraining (AR) or control VP task. Participants will be asked to carry around a smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy (Phase 1).
The smartphone will sound an alert randomly during the day, at which time participants will be asked to respond to a short set of questions assessing subjective states; this will be followed by a request to complete the AR (or control) procedures. This same procedure will be repeated for 2 weeks immediately after delivery (Phase 2).
Women will undergo a follow-up visit 3 months after the end of Phase 2, and complete an unmodified VP and follow-up assessments.
There are 2 specific aims that this study intends to address.
Specific Aim 1: To examine whether AR delivered on a smartphone can modify attentional bias to smoking-related stimuli and craving for tobacco cigarettes.
Specific Aim 2: To examine whether AR delivered on a smartphone can modify attentional bias to stress-related stimuli and reduce perceived stress.
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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.
Behavioral: Attentional retraining (AR)
The visual probe (VP) task can measure attentional bias for drug-related cues.
Behavioral: Visual probe (VP)
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.
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
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.
Time frame: end of phase 2, up to 3 months
Attentional Bias Toward Stressrelated Stimuli
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.
Time frame: end of phase 2, up to 3 months
Self-reported Craving
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.
Time frame: end of phase 2, up to 3 months
Self-reported Stress
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.
Time frame: end of phase 2, up to 3 months
Smoking Relapse
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.
Time frame: from randomization to 6-month follow-up, up to 8 months
| Milestone | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Started | 13 | 9 |
| Completed | 13 | 9 |
| Not completed | 0 | 0 |
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.
| milliseconds | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Attentional Bias- Smoking Related Stimuli | -44.0 ± 170.9 | 37.9 ± 163.6 |
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.
| milliseconds | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Attentional Bias Toward Stressrelated Stimuli | -12.1 ± 130.6 | -46.5 ± 94.8 |
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.
| score on 7-point Likert scale | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Self-reported Craving | 1.35 ± 0.89 | 1.66 ± 1.82 |
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.
| score on a scale | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Self-reported Stress | 3.34 ± 0.77 | 3.57 ± 0.70 |
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.
| Participants | Attentional Retraining (AR) | Visual Probe (VP) |
|---|---|---|
| Smoking Relapse | 4 | 2 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Attentional Retraining (AR) | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Visual Probe (VP) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Customized(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| >30 years | 10 | 4 | 14 |
| ≤30 years | 3 | 5 | 8 |
| Sex: Female, Male(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| Female | 13 | 9 | 22 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| Hispanic, White | 2 | 1 | 3 |
| Hispanic, Black | 3 | 1 | 4 |
| Black, non-Hispanic | 8 | 6 | 14 |
| >1 Race, non-Hispanic | 0 | 1 | 1 |
| Region of Enrollment(participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| United States | 13 | 9 | 22 |
| Education(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| < High school degree | 1 | 2 | 3 |
| High school degree | 5 | 2 | 7 |
| Some college (no degree) | 5 | 5 | 10 |
| Associate's degree | 1 | 0 | 1 |
| Refuse to Answer | 1 | 0 | 1 |
| Pre-quit smoking level(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| ≤10 cigarettes/day | 11 | 5 | 16 |
| >10 cigarettes/day | 2 | 4 | 6 |
| Anxiety(Participants) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| Yes | 4 | 5 | 9 |
| No | 9 | 4 | 13 |
| Age started smoking (years)(years) | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| Mean | 15.8 ± 3.2 | 15.9 ± 1.5 | 15.8 ± 2.6 |
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