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A Mood Management Intervention for Pregnant Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505869
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 2, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Pregnancy Smoking Behavioral: Health & Wellness Intervention Behavioral: Questionnaire Behavioral: Mood Management Intervention

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Study Type : Observational
Actual Enrollment : 338 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Mood Management Intervention for Pregnant Smokers
Study Start Date : August 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Group/Cohort Intervention/treatment
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

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.

Primary Outcome Measures :
  1. Number of Patients with Prolonged Abstinence [ Time Frame: 3 month assessments from end of treatment ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are pregnant smokers who may be under stress.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505869

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Paul Cinciripini, PhD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00505869    
Other Study ID Numbers: 2004-0022
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012
Keywords provided by M.D. Anderson Cancer Center:
Pregnant Smokers
Mood Management Intervention
Health & Wellness Intervention
Smoking Cessation