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Attentional Retraining for Smoking Relapse (PARIS Trial)
N/A
Waitlist Available
Led By Ariadna Forray, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights
PARIS Trial Summary
This trial will test whether the addition of the AR task to the VP task will increase the efficacy of the VP task in reducing postpartum smoking relapse.
Who is the study for?
This trial is for Black or Hispanic women who smoked at least 5 cigarettes daily but quit by the 32nd week of pregnancy. They must speak English and have low depression scores. It's not for those planning to move, facing jail time, breastfeeding, abusing substances, hospitalized during the study, or with recent major depression or psychosis.Check my eligibility
What is being tested?
The study tests if a smartphone-based attentional retraining (AR) can prevent smoking relapse in pregnant women compared to a control task. Participants will answer questions and perform tasks on their phones during late pregnancy and after delivery, followed by a check-up three months later.See study design
What are the potential side effects?
Since this intervention involves psychological exercises rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort from frequent alerts and assessments on their smartphones.
PARIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Attentional Bias toward stressrelated stimuli
Attentional Bias- Smoking Related Stimuli
Secondary outcome measures
Self-reported craving
Self-reported stress
Smoking relapse
PARIS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: attentional retraining (AR)Experimental Treatment1 Intervention
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.
Group II: visual probe (VP)Active Control1 Intervention
The visual probe (VP) task can measure attentional bias for drug-related cues.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attentional retraining (AR)
2020
N/A
~30
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Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,189 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,191 Total Patients Enrolled
Ariadna Forray, MDPrincipal InvestigatorAssociate Professor of Psychiatry; Psychiatry Director, Adult Sickle Cell Program; Co-Director, Center for Wellbeing of Women and Mothers
2 Previous Clinical Trials
305 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the Edinburgh Postnatal Depression Scale (EPDS) is less than 10.You are currently experiencing significant depression or have had a history of depression in the past 6 months.You have a mental illness that causes hallucinations or delusions.
Research Study Groups:
This trial has the following groups:- Group 1: attentional retraining (AR)
- Group 2: visual probe (VP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov lists this clinical trial as currently recruiting patients, which it began searching for on November 18th 2020 and last updated August 11th 2022. The study is seeking 50 individuals to participate at one particular medical centre."
Answered by AI
Are there still open slots available for participation in this research project?
"Yes, as per the information posted on clinicaltrials.gov this research is actively recruiting participants. It was first launched in November 18th 2020 and underwent a recent update on August 11th 2022."
Answered by AI
What criteria should prospective participants in this research meet?
"To gain entry into this experiment, participants must have had a recurrence of their condition and be between 18 to 40 years old. This study is looking for approximately 50 enrollees."
Answered by AI
Can those over 30 years of age participate in this research?
"This medical experiment requires that potential participants are between 18 and 40 years old. By contrast, there are 160 trials for those under the age of majority and 908 studies available to seniors over 65."
Answered by AI
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