A Mood Management Intervention for Pregnant Smokers

NCT00505869 | Completed DMC

• 1 other identifier: 2004-0022
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal is aimed at testing the following hypotheses:

1. 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. 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. 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.

Conditions

Pregnancy; Smoking

Keywords

Pregnant Smokers; Mood Management Intervention; Health & Wellness Intervention; Smoking Cessation; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Prolonged Abstinence

  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.

  3 month assessments from end of treatment

Study Arms (2)

1

Health \& Wellness Intervention + Questionnaire

Behavioral: Health & Wellness Intervention; Behavioral: Questionnaire

2

Mood Management Intervention + Questionnaire

Behavioral: Questionnaire; Behavioral: Mood Management Intervention

Interventions

Health & Wellness Intervention BEHAVIORAL

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.

1

Questionnaire BEHAVIORAL

Questionnaires about mood, confidence in quitting, smoking behavior, and social support.

Also known as: Survey

1; 2

Mood Management Intervention BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are pregnant smokers who may be under stress.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample for cotinine.

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Health; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Paul Cinciripini, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: August 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)