MDACC Study Summary 2004-0022 (Archived)

Study Summary
No. 2004-0022:.......Cancer Prevention......Paul Cinciripini......Behavioral Science

Study Summary Title



Study Summary Number:	2004-0022

Study Title:	A Mood Management Intervention for Pregnant Smokers

Physician

New Patient Referral



Name:	Paul Cinciripini	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Participants will attend one orientation/baseline session, 10 weekly sessions, and 2 follow-up visits.

Treatment Agents:	Behavioral Intervention	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to test the effectiveness of health education versus a mood management treatment for helping pregnant women quit smoking. The study will also look at the relationship between depression and quitting smoking.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	08/25/2004

IRB Review and Approval Date:	06/16/2004

Study Type:	Early Detection

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 1) Gestation: < or = 32 weeks pregnant at baseline 2) Age: 16 years or older 3) 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. 4) English speaking & have a telephone 5) Willing to attend all sessions and have no known complications that would adversely affect attendance 6) Other: provide informed consent & agree to all assessments & study procedures

Exclusion Criteria:

1) 1) Current psychotherapy 2) Involvement within one day of telephone screen with any smoking cessation activities other than those that are freely available in the public domain. 3) History of/current medical condition, or any other factor, that, in the judgment of the Principal Investigator, would likely preclude completion of study requirements.

Links

Registration Number: NCT00505869
Study Information on Clinical Trials Registry (clinicaltrials.gov)