Strategies to Avoid Returning to Smoking (STARTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00757068
First received: September 19, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the relative efficacy of a postpartum smoking relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women who remain abstinent through 12 months postpartum. We hypothesize that women randomized to STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.


Condition Intervention
Smoking
Behavioral: CBT addressing postpartum mood and weight concerns
Behavioral: Supportive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Abstinence at 12 months postpartum [ Time Frame: through 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore factors associated with abstinence postpartum. [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SBT
Women assigned to SBT (blue) will receive a six month program that offers to help them stay quit after having a baby.
Behavioral: Supportive Behavioral Therapy
Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. A non-specific, supportive condition will be delivered to women who want to remain smoke-free after they give birth.
Other Names:
  • Smoking cessation
  • General
Experimental: CBT
Women assigned to CBT (pink) will receive a six month treatment designed to provide support and address the concerns of women who have just had a baby and do not want to resume smoking.
Behavioral: CBT addressing postpartum mood and weight concerns
Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. In these treatment sessions, the counselor will address postpartum mood and weight concerns.
Other Names:
  • STARTS
  • Strategies to Avoid Returning to Smoking

Detailed Description:

The goal of the proposed investigation is to determine whether a cognitive behavioral relapse prevention intervention designed to address mood and weight concerns during the postpartum period will decrease the rate of postpartum relapse to smoking. We propose a two-group, randomized controlled trial. Women who quit smoking as a result of pregnancy, have been quit for at least one month prior to delivery and are motivated to remain abstinent postpartum will complete baseline assessments and be randomly assigned during the third trimester of pregnancy to either a cognitive behavioral relapse prevention intervention specifically designed for women who quit smoking during pregnancy, Strategies to Avoid Returning To Smoking (STARTS), or a nonspecific, supportive condition (SUPPORT). Both conditions will receive written information on the dangers of postpartum smoking and an equivalent number and amount of sessions immediately prior to delivery and during the first six months postpartum. Women will be treated for the first six months postpartum because substantial evidence has shown the risk of relapse to be greatest during the six months immediately following delivery (McBride et al., 1990; Mullen et al., 1990). All women will complete assessments at baseline (during pregnancy) and 3, 6 and 12 months postpartum.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women will be eligible to participate if they:

    • report having smoked daily for at least one month during the 3 months prior to becoming pregnant;
    • smoked at least 10 cigarettes per day before quitting;
    • report no smoking in the four weeks prior to enrollment;
    • are not currently smoking as verified by a CO less than 8ppm;
    • are at least 'somewhat' motivated to remain abstinent postpartum and
    • are at least 14 years of age.

Exclusion Criteria:

  • Women with current, acute psychiatric disorders, including other substance use problems and symptoms that warrant immediate treatment will be referred for care and excluded from this trial.
  • Women with psychiatric disorders (e.g., depressive or anxiety disorders), who are not acutely suicidal and in whom the symptoms are not severe enough to preclude participation in a randomized trial, will be eligible to participate. However, women taking psychiatric medications that may affect the mediators of treatment, such as antidepressant, anxiolytic or weight control medications, will be excluded from participation.
  • Women who endorse current suicidality will be discussed immediately with the consulting physician and referred to the psychiatric emergency room for further evaluation as indicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757068

Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Michele D Levine, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00757068     History of Changes
Other Study ID Numbers: LEVINER01, R01DA021608, R01 DA021608
Study First Received: September 19, 2008
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Non-smoking
Women
Pregnancy
Treatment
Mood
Weight
Supportive
Adjustment

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 28, 2014