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Completed

NCT Number: NCT04114877

Perinatal Attentional Retraining Intervention for Smoking for Minority Women

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Attentional Bias- Smoking Related Stimuli

    Time frame: 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.

  2. Attentional Bias Toward Stressrelated Stimuli

    Time frame: 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 outcomes

  1. Self-reported Craving

    Time frame: 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.

  2. Self-reported Stress

    Time frame: 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.

  3. Smoking Relapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Perinatal Attentional Retraining Intervention for Smoking (PARIS) for Minority Women

Acronym: PARIS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2019
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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