Smoking CessationPhase 1/2NCT01163864
Affect Regulation Training for Pregnant Smokers
A Phase 1/2 study testing affect regulation training and health and lifestyle in people with Smoking Cessation, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- affect regulation training and health and lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- acute psychosis,
- lack of familiarity with the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Institute on Addictions, University at Buffalo
Buffalo, New York, 14203-1016
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- affect regulation training, health and lifestyle
- Keywords
- smoking, smoking relapse, smoking cessation, pregnancy, smoking cessation in pregnant women
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
affect regulation trainingBehavioural
8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention
health and lifestyleBehavioural
8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention
| Study group | Role | What they receive |
|---|---|---|
| affect regulation training | Experimental | Not described Receives: Behavioral: affect regulation training |
| health and lifestyle | Active comparator | Not described Receives: Behavioral: health and lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking cessation rate using the Timeline Followback Interview for smoking
We will compare the number of women who are abstinent from smoking in the ART+CBT group vs. the HLS+CBT group using the Timeline Followback Interview for smoking
Measured: end of 8 session treatment (about 2 months after treatment initiation)
Secondary outcomes (5)
smoking cessation rate using the Timelineline Followback Interview for smoking
We will compare the number of women who are abstinent from cigarettes in the ART+CBT group vs. the HLS+CBT group using the Timeline Followback Interview for smoking
Measured: 6-month post-quit date (Session 2 is always the quit date)
treatment feasibility
We will compare the number of women who complete the 8-session treatment in the ART+CBT vs. he HLS+CBT group.
Measured: end of 8-session treatment
treatment acceptability
We will compare the treatment ratings by participants for the ART+CBT group vs. the HLS+CBT group using the Treatment Acceptability Questionnaire
Measured: end of 8-session treatment
affect regulation skills
We will compare the scores on measures of affect regulation skills of ART+CBT group vs. HLS+CBT group using the Difficulties in Emotion Regulation Scale (DERS).
Measured: end of 8-session treatment
negative affect
We will compare levels of negative at the end of treatment of the ART+CBT group vs. the HLS+CBT group using both Positive and Negative Affect Scale
Measured: end of 8-session treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Clara Bradizza, State University of New York at Buffalo
- Investigators
- Clara Bradizza, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163864
- Sponsor's protocol ID
- Q607
- Other IDs
- R01DA021802
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2010
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30286396
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect Regulation Training for Pregnant Smokers
- ClinicalTrials.gov ID
- NCT01163864
- Acronym / sponsor ID
- Q607
- Conditions
- Smoking Cessation
- Keywords
- smoking, smoking relapse, smoking cessation, pregnancy, smoking cessation in pregnant women
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| affect regulation training | Experimental | Behavioral: affect regulation training |
| health and lifestyle | Active comparator | Behavioral: health and lifestyle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-40 years of age,
- pregnancy involving single birth,
- less than 24 weeks pregnant,
- negative affect smoker,
- smoking at least 1 cigarette per day,
Key exclusion criteria (2 listed)
- acute psychosis,
- lack of familiarity with the English language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| affect regulation training8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention | Behavioural | affect regulation training |
| health and lifestyle8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention | Behavioural | health and lifestyle |
Primary outcome
smoking cessation rate using the Timeline Followback Interview for smoking
Time frame: end of 8 session treatment (about 2 months after treatment initiation)
We will compare the number of women who are abstinent from smoking in the ART+CBT group vs. the HLS+CBT group using the Timeline Followback Interview for smoking
5 secondary outcomes
smoking cessation rate using the Timelineline Followback Interview for smoking
Time frame: 6-month post-quit date (Session 2 is always the quit date)
treatment feasibility
Time frame: end of 8-session treatment
treatment acceptability
Time frame: end of 8-session treatment
affect regulation skills
Time frame: end of 8-session treatment
negative affect
Time frame: end of 8-session treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 30286396Fillo 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.
- Research Institute on Addiction websiteLink provided by the sponsor.
- Description of project on institutional websiteLink provided by the sponsor.
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Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Bradizza, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing affect regulation training and health and lifestyle in people with Smoking Cessation, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking cessation rate using the Timeline Followback Interview for smoking (time frame: end of 8 session treatment (about 2 months after treatment initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.