Perinatal Attentional Retraining Intervention for Smoking for Minority Women

NCT04114877 | Completed Results DMC

• 2 other identifiers: 10080072451R21MD012697-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Smoking Relapse

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Self-reported Craving

  end of phase 2, up to 3 months

• Self-reported Stress

  end of phase 2, up to 3 months

• Smoking Relapse

  from randomization to 6-month follow-up, up to 8 months

Study Arms (2)

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.

Behavioral: Attentional retraining (AR)

visual probe (VP)

ACTIVE COMPARATOR

The visual probe (VP) task can measure attentional bias for drug-related cues.

Behavioral: Visual probe (VP)

Interventions

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.

attentional retraining (AR)

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.

visual probe (VP)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Results Point of Contact

• Title: Ariadna Forray
• Organization: Yale School of Medicine

ariadna.forray@yale.edu

2037648620

Study Officials

• Ariadna Forray, MD

  Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: November 18, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)