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Perinatal Attentional Retraining Intervention for Smoking for Minority Women

NCT04114877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-18

Study results available
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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.

Conditions

  • Postpartum Smoking Relapse

Interventions

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.

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Ariadna Forray, MD · Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114877 on ClinicalTrials.gov