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NCT00505869 · ClinicalTrials.gov registry record

A Mood Management Intervention for Pregnant Smokers

A clinical trial, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
338
Enrollment target

NCT00505869: Completed study, sponsored by M.D. Anderson Cancer Center.

NCT00505869 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 338 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00505869 has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
338 participants
Enrollment target

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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Questionnaire
  • BEHAVIORAL Health & Wellness Intervention
  • BEHAVIORAL Mood Management Intervention

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2004-08
Est. Completion 2010-04
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00505869 record still lists

NCT00505869 is an observational study that tracks outcomes without assigning an intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 3 interventions - of which Questionnaire is the first listed.

NCT00505869 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00505869 about?

NCT00505869 is a clinical study titled "A Mood Management Intervention for Pregnant Smokers". 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 ...

What is the current status of trial NCT00505869?

This trial is currently completed. The enrollment target is 338 participants. The study started on 2004-08. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00505869?

The interventions under investigation include: Questionnaire (BEHAVIORAL), Health & Wellness Intervention (BEHAVIORAL), Mood Management Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00505869?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00505869, the US trial registry maintained by the National Library of Medicine. NCT00505869 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.