A Mood Management Intervention for Pregnant Smokers - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Institute on Drug Abuse (NIDA)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00505869

Purpose

This proposal is aimed at testing the following hypotheses:

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.
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.
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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Mood Management Intervention for Pregnant Smokers

Resource links provided by NLM:

MedlinePlus related topics: Depression Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

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

Primary Outcome Measures:

To test the effectiveness of health education versus a mood management treatment for helping pregnant women quit smoking. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To review the relationship between depression and quitting smoking. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	August 2004
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental Mood Management Intervention + Questionnaire	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.

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Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Paul Cinciripini, PhD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Paul Cinciripini, PhD/Professor )
Study ID Numbers:	2004-0022
Study First Received:	July 23, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00505869 History of Changes
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

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on September 11, 2009