Clinical trial NCT04114877: Perinatal Attentional Retraining Intervention for Smoking for Minority Women
Official title: Perinatal Attentional Retraining Intervention for Smoking (PARIS) for Minority Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Smoking Relapse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-10-03
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Attentional Bias- Smoking Related Stimuli
timeFrame: end of phase 2, up to 3 months
measure: Attentional Bias Toward Stressrelated Stimuli
timeFrame: end of phase 2, up to 3 months
Secondary outcomes:
measure: Self-reported Craving
timeFrame: end of phase 2, up to 3 months
measure: Self-reported Stress
timeFrame: end of phase 2, up to 3 months
measure: Smoking Relapse
timeFrame: from randomization to 6-month follow-up, up to 8 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Associate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers
name: Ariadna Forray, MD
role: PRINCIPAL_INVESTIGATOR
References: