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

Yale University

Status: Completed

Conditions: Postpartum Smoking Relapse

Treatments: Behavioral: Visual probe (VP); Behavioral: Attentional retraining (AR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04114877

1R21MD012697-01A1 (U.S. NIH Grant/Contract)

1008007245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

attentional retraining (AR)

Experimental group

Description:

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.

Treatment:

Behavioral: Attentional retraining (AR)

visual probe (VP)

Active Comparator group

Description:

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

Treatment:

Behavioral: Visual probe (VP)