Clinical trial NCT01163864: Affect Regulation Training for Pregnant Smokers
Official title: Affect Regulation Training for Pregnant Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking Cessation
Keywords: smoking
smoking relapse
smoking cessation
pregnancy
smoking cessation in pregnant women
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-07-16
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent data indicate that approximately one-third of women of childbearing age smoke cigarettes, and 25-50% of women smoke during pregnancy. Cigarette smoking during pregnancy is a significant public health issue that can have profound effects on women's health and the health of their developing fetus. Smoking among pregnant women is associated with high levels of negative affect, which play a key role in the maintenance of smoking behavior and in difficulty quitting smoking during pregnancy. Despite the clear role of negative affect in the maintenance of smoking among pregnant women, and while this issue has received increased attention by clinicians and researchers, the investigators know of no smoking cessation intervention that combines coping skills and emotion regulation approaches to address the role of negative affect in smoking cessation. Smoking cessation treatment strategies that have demonstrated effectiveness in regular smokers have not translated into effective treatment strategies for pregnant women, particularly low-income pregnant women. The goal of this project is to develop and test an affect regulation smoking cessation intervention for low-income pregnant smokers.

The major aims of this project will be addressed in two sequential phases. In Phase 1, the investigators will develop two 8-session smoking cessation treatment manuals including: (a) Affect Regulation Training plus Cognitive-Behavioral Treatment (ART+CBT) and (b) a Health and Lifestyle plus Cognitive-Behavioral Treatment (HLS+CBT) control intervention. In Phase 2, the investigators will conduct a randomized clinical trial pilot study (Total N = 60) to compare the ART+CBT and HLS+CBT conditions on: a) the feasibility and acceptability of the interventions, (b) the impact of these interventions (ART+CBT and HLS+CBT) on smoking cessation rates at the end of the 8 treatment sessions (these occur approximately 2 months after treatment initiation) and at the 6-month post-quit date assessment (Session 2 is the quit date), (c) affect regulation skills, and (d) negative affect among pregnant smokers. The long-term goal of this proposed research is to increase smoking cessation rates among pregnant smokers, which would provide significant long-term health benefits for both mothers and their infants. This Stage 1 application will be used to generate feasibility and preliminary efficacy data, setting the stage for a Stage II efficacy trial.


Eligibility criteria: Inclusion Criteria:

* 18-40 years of age,
* pregnancy involving single birth,
* less than 24 weeks pregnant,
* negative affect smoker,
* smoking at least 1 cigarette per day,
* no substance abuse diagnosis except marijuana,
* no more than .50 ounces of ethanol per day,
* can provide a collateral to verify smoking information.

Exclusion Criteria:

* acute psychosis,
* lack of familiarity with the English language.

Primary outcomes:
measure: smoking cessation rate using the Timeline Followback Interview for smoking
timeFrame: end of 8 session treatment (about 2 months after treatment initiation)
Secondary outcomes:
measure: smoking cessation rate using the Timelineline Followback Interview for smoking
timeFrame: 6-month post-quit date (Session 2 is always the quit date)
measure: treatment feasibility
timeFrame: end of 8-session treatment
measure: treatment acceptability
timeFrame: end of 8-session treatment
measure: affect regulation skills
timeFrame: end of 8-session treatment
measure: negative affect
timeFrame: end of 8-session treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Research Institute on Addictions, University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Clara Bradizza, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fillo J, Kamper-DeMarco KE, Brown WC, Stasiewicz PR, Bradizza CM. Emotion regulation difficulties and social control correlates of smoking among pregnant women trying to quit. Addict Behav. 2019 Feb;89:104-112. doi: 10.1016/j.addbeh.2018.09.033. Epub 2018 Sep 26.