A Mood Management Intervention for Pregnant Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505869
First received: July 23, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

This proposal is aimed at testing the following hypotheses:

  1. Cessation rates will be significantly greater for smokers in a mood management condition versus a health & wellness condition during pregnancy and at 3 and 6 months postpartum.
  2. Pregnant smokers who have a higher level of depressive symptomatology will quit significantly less often in the health & wellness condition vs. mood management condition; those with a lower level of depressive symptomatology will not demonstrate this treatment difference.
  3. Pregnant smokers who show higher levels of current depression at the start of the intervention will quit significantly less often than those smokers with lower levels.

The mood management intervention will result in higher levels of adaptive coping behavior, self-efficacy, social support, and perceived support from the counselor, and lower levels of negative affect, rumination, and perceived stress, than the health & wellness intervention and these variables will be related to abstinence. Thus, we will evaluate the effects of the intervention (health & wellness and mood management) on hypothesized treatment mechanisms, and assess the impact of those mechanisms on abstinence.


Condition Intervention Phase
Pregnancy
Smoking
Behavioral: Health & Wellness Intervention
Behavioral: Questionnaire
Behavioral: Mood Management Intervention
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Mood Management Intervention for Pregnant Smokers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Prolonged Abstinence [ Time Frame: 3 month assessments from end of treatment ] [ Designated as safety issue: No ]
    Prolonged abstinence assessed following treatment through 6 months postpartum to test effectiveness of health education versus a mood management treatment for helping pregnant women quit smoking.


Biospecimen Retention:   Samples Without DNA

Saliva sample for cotinine.


Enrollment: 338
Study Start Date: August 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Health & Wellness Intervention + Questionnaire
Behavioral: Health & Wellness Intervention
Counseling focusing on health concerns related to pregnancy, information about smoking and pregnancy, tips for quitting, and problem-solving skills to manage situations that might be triggers for smoking.
Behavioral: Questionnaire
Questionnaires about mood, confidence in quitting, smoking behavior, and social support.
Other Name: Survey
2
Mood Management Intervention + Questionnaire
Behavioral: Questionnaire
Questionnaires about mood, confidence in quitting, smoking behavior, and social support.
Other Name: Survey
Behavioral: Mood Management Intervention
Counseling focusing on learning to manage negative moods (depressed mood, tension, anxiety), as well as providing tips for quitting smoking, problem-solving skills, and information about smoking and pregnancy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who are pregnant smokers who may be under stress.

Criteria

Inclusion Criteria:

  • Gestation: < or = 32 weeks pregnant at baseline
  • Age: 16 years or older
  • Smoking: at least a puff of a cigarette in the past 7 days & willing to set quit date that occurs before the end of treatment.
  • English speaking & have a telephone
  • Willing to attend all sessions and have no known complications that would adversely affect attendance
  • Other: provide informed consent & agree to all assessments & study procedures

Exclusion Criteria:

  • Current psychotherapy
  • Involvement within one day of telephone screen with any smoking cessation activities other than those that are freely available in the public domain.
  • History of/current medical condition, or any other factor, that, in the judgment of the Principal Investigator, would likely preclude completion of study requirements.
  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: NCT00505869

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul Cinciripini, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505869     History of Changes
Other Study ID Numbers: 2004-0022
Study First Received: July 23, 2007
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pregnant Smokers
Mood Management Intervention
Health & Wellness Intervention
Smoking Cessation
Questionnaire
Survey

ClinicalTrials.gov processed this record on August 01, 2014