Perinatal Attentional Retraining Intervention for Smoking for Minority Women

Postpartum Smoking Relapse Clinical Trial

— PARIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114877
• Other study ID #: 1008007245
• Secondary ID: 1R21MD012697-01A
• Status: Completed
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Smoking Relapse
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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