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

Primary Purpose

Postpartum Smoking Relapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attentional retraining (AR)
Visual probe (VP)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Smoking Relapse

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

attentional retraining (AR)

visual probe (VP)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 2, 2019
Last Updated
March 17, 2023
Sponsor
Yale University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04114877
Brief Title
Perinatal Attentional Retraining Intervention for Smoking for Minority Women
Acronym
PARIS
Official Title
Perinatal Attentional Retraining Intervention for Smoking (PARIS) for Minority Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Smoking Relapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
attentional retraining (AR)
Arm Type
Experimental
Arm 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.
Arm Title
visual probe (VP)
Arm Type
Active Comparator
Arm Description
The visual probe (VP) task can measure attentional bias for drug-related cues.
Intervention Type
Behavioral
Intervention Name(s)
Attentional retraining (AR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visual probe (VP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attentional Bias- Smoking Related Stimuli
Description
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.
Time Frame
Up to 8 months
Title
Attentional Bias toward stressrelated stimuli
Description
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.
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Self-reported craving
Description
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.
Time Frame
Up to 8 months
Title
Self-reported stress
Description
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.
Time Frame
Up to 8 months
Title
Smoking relapse
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariadna Forray, MD
Phone
(203) 764-8620
Email
ariadna.forray@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariadna Forray, MD
Organizational Affiliation
Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariadna Forray, MD
Phone
203-764-8620
Email
ariadna.forray@yale.edu
First Name & Middle Initial & Last Name & Degree
Ariadna Forray, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Perinatal Attentional Retraining Intervention for Smoking for Minority Women

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