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Perinatal Attentional Retraining Intervention for Smoking for Minority Women

Not Applicable
Completed
Conditions
Postpartum Smoking Relapse
Interventions
Behavioral: Attentional retraining (AR)
Behavioral: Visual probe (VP)
Registration Number
NCT04114877
Lead Sponsor
Yale University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
22
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
attentional retraining (AR)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.
visual probe (VP)Visual probe (VP)The visual probe (VP) task can measure attentional bias for drug-related cues.
Primary Outcome Measures
NameTimeMethod
Attentional Bias toward stressrelated stimuliUp to 8 months

Attentional bias (AB) is assessed using the standard (unmodified) visual probe 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 stressrelated word vs. trials where the probe replaced the neutral word.

Attentional Bias- Smoking Related StimuliUp to 8 months

Attentional bias (AB) is assessed using the standard (unmodified) visual probe 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.

Secondary Outcome Measures
NameTimeMethod
Self-reported cravingUp to 8 months

Self-reported craving is a single item that assesses craving to cigarettes on a 7-point Likert scale 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.

Self-reported stressUp to 8 months

Self-reported stress is assessed using the Perceived Stress Scale, modified to ask about daily stress, in the daily assessments delivered on the smartphone and at study visits. The mean score will be computed. Higher scores on the scale are indicative of higher stress.

Smoking relapseUp to 6 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.

Trial Locations

Locations (1)

Yale University

🇺🇸

New Haven, Connecticut, United States

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