Postpartum Smoking Relapse
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAttentional 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.
BEHAVIORALVisual 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with a history of smoking 5+ cigarettes per day that have achieved abstinence during pregnancy by 32 weeks gestation. * The ability to speak and write English. * An Edinburgh Postnatal Depression Scale (EPDS) score \<10.
Exclusion criteria
* Current substance abuse (e.g., alcohol, benzodiazepines, marijuana). * Current major depressive disorder, minor depression or dysthymia, or history of any of these disorders in the last 6 months. * The presence of an Axis I psychotic disorder. * Plans to relocate out of the area. * Imminent incarceration. * Planned inpatient hospitalization during study period. * Plans to breastfeed. Women who plan to breastfeed will be excluded since this is a powerful, independent motivation for remaining abstinent and may decrease the relapse event rate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attentional Bias- Smoking Related Stimuli | end of phase 2, up to 3 months | 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. |
| Attentional Bias Toward Stressrelated Stimuli | end of phase 2, up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Craving | end of phase 2, up to 3 months | 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. |
| Self-reported Stress | end of phase 2, up to 3 months | 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. |
| Smoking Relapse | from randomization to 6-month follow-up, up to 8 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 9 |
| Total | 22 |
Baseline characteristics
| Characteristic | Attentional Retraining (AR) | Visual Probe (VP) | Total |
|---|---|---|---|
| Age, Customized ≤30 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Customized >30 years | 10 Participants | 4 Participants | 14 Participants |
| Age started smoking (years) | 15.8 years STANDARD_DEVIATION 3.2 | 15.9 years STANDARD_DEVIATION 1.5 | 15.8 years STANDARD_DEVIATION 2.6 |
| Anxiety No | 9 Participants | 4 Participants | 13 Participants |
| Anxiety Yes | 4 Participants | 5 Participants | 9 Participants |
| Education Associate's degree | 1 Participants | 0 Participants | 1 Participants |
| Education < High school degree | 1 Participants | 2 Participants | 3 Participants |
| Education High school degree | 5 Participants | 2 Participants | 7 Participants |
| Education Refuse to Answer | 1 Participants | 0 Participants | 1 Participants |
| Education Some college (no degree) | 5 Participants | 5 Participants | 10 Participants |
| Pre-quit smoking level ≤10 cigarettes/day | 11 Participants | 5 Participants | 16 Participants |
| Pre-quit smoking level >10 cigarettes/day | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized >1 Race, non-Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 8 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic, Black | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic, White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 13 participants | 9 participants | 22 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 0 / 13 | 0 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attentional Retraining (AR) | Attentional Bias- Smoking Related Stimuli | -44.0 milliseconds | Standard Deviation 170.9 |
| Visual Probe (VP) | Attentional Bias- Smoking Related Stimuli | 37.9 milliseconds | Standard Deviation 163.6 |
p-value: >0.05Mixed Models Analysis
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attentional Retraining (AR) | Attentional Bias Toward Stressrelated Stimuli | -12.1 milliseconds | Standard Deviation 130.6 |
| Visual Probe (VP) | Attentional Bias Toward Stressrelated Stimuli | -46.5 milliseconds | Standard Deviation 94.8 |
p-value: >0.05Mixed Models Analysis
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attentional Retraining (AR) | Self-reported Craving | 1.35 score on 7-point Likert scale | Standard Deviation 0.89 |
| Visual Probe (VP) | Self-reported Craving | 1.66 score on 7-point Likert scale | Standard Deviation 1.82 |
p-value: >0.05Mixed Models Analysis
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attentional Retraining (AR) | Self-reported Stress | 3.34 score on a scale | Standard Deviation 0.77 |
| Visual Probe (VP) | Self-reported Stress | 3.57 score on a scale | Standard Deviation 0.7 |
p-value: >0.05Mixed Models Analysis
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attentional Retraining (AR) | Smoking Relapse | 4 Participants |
| Visual Probe (VP) | Smoking Relapse | 2 Participants |
p-value: 0.455Fisher Exact