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A Mood Management Intervention for Pregnant Smokers

NCT00505869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 338

Last updated 2012-08-02

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Smoking

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paul Cinciripini, PhD · M.D. Anderson Cancer Center

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505869 on ClinicalTrials.gov