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

Perinatal Attentional Retraining Intervention for Smoking (PARIS) 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.

Study Overview

• Status: Completed
• Conditions: Postpartum Smoking Relapse
• Intervention / Treatment: Behavioral: Attentional retraining (AR); Behavioral: Visual probe (VP)

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariadna Forray, MD; Phone Number: (203) 764-8620; Email: ariadna.forray@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: visual probe (VP); The visual probe (VP) task can measure attentional bias for drug-related cues.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Bias- Smoking Related Stimuli	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.	Up to 8 months
Attentional Bias toward stressrelated stimuli	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.	Up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported craving	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.	Up to 8 months
Self-reported stress	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.	Up to 8 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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ariadna Forray, MD, Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 1008007245; 1R21MD012697-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No