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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MD012697-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| attentional retraining (AR) | Experimental | 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. |
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| visual probe (VP) | Active Comparator | The visual probe (VP) task can measure attentional bias for drug-related cues. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attentional retraining (AR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | end of phase 2, up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariadna Forray, MD | Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | end of phase 2, up to 3 months |
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariadna Forray | Yale School of Medicine | 2037648620 | ariadna.forray@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2023 | Dec 20, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2023 | Feb 27, 2024 | ICF_000.pdf |
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|
| Visual probe (VP) | Behavioral | 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. |
|
| 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. | 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. | from randomization to 6-month follow-up, up to 8 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
|
| Pre-quit smoking level | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Age started smoking (years) | Mean | Standard Deviation | years |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | end of phase 2, up to 3 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on 7-point Likert scale | end of phase 2, up to 3 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | end of phase 2, up to 3 months |
|
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|
|
| 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. | 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. | Posted | Count of Participants | Participants | from randomization to 6-month follow-up, up to 8 months |
|
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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