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

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ClinicalTrials.gov Identifier: NCT04114877
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Yale University

Brief Summary:

The proposed research intends to randomize 50 abstinent pregnant 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.


Condition or disease Intervention/treatment Phase
Postpartum Smoking Relapse Behavioral: Attentional retraining (AR) Behavioral: Visual probe (VP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Perinatal Attentional Retraining Intervention for Smoking (PARIS) for Minority Women
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: attentional retraining (AR)
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)
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.

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




Primary Outcome Measures :
  1. Attentional Bias- Smoking Related Stimuli [ Time Frame: Up to 8 months ]
    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.

  2. Attentional Bias toward stressrelated stimuli [ Time Frame: Up to 8 months ]
    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 :
  1. Self-reported craving [ Time Frame: Up to 8 months ]
    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.

  2. Self-reported stress [ Time Frame: Up to 8 months ]
    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.

  3. Smoking relapse [ Time Frame: Up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114877


Contacts
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Contact: Ariadna Forray, MD (203) 764-8620 ariadna.forray@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ariadna Forray, MD    203-764-8620    ariadna.forray@yale.edu   
Principal Investigator: Ariadna Forray, MD         
Sponsors and Collaborators
Yale University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Ariadna Forray, MD Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04114877    
Other Study ID Numbers: 1008007245
1R21MD012697-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes