A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers (NCT05044546) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
United States26 participantsStarted 2021-10-19
Plain-language summary
This study evaluates a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth. This study may help pregnant smokers who are experiencing depression quit smoking and stay smoke-free after their babies are born.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Pregnant (or within 4 months post-partum for aim 1 only)
ā. Meets criteria for current Major Depressive Disorder (MDD) as assessed by the Mini International Neuropsychiatric Interview (MINI) 7.0.2 OR PHQ score of 10 or greater.
ā. ā„ 18 years of age
ā. Have a telephone
ā. Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
ā. Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum
ā. Able to speak and read English
ā. Subjects must report a current residence in the State of Texas
Exclusion criteria
ā. Rated on the Columbia-Suicide Severity Rating Scale113 at screening as in the past month having had active suicidal ideation with some intent to act or active suicidal ideation with specific plan and intent (indicated by answering "YES" on both Q3 and Q4, and/or 5) and/or endorsing "YES" to having engaged in preparatory acts towards or attempting suicide in the past 3 months (as indicated by answering "YES" to both parts of Q6)
ā. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
ā. Have a past or current diagnosis of Bipolar Disorder I or II or have a past or current diagnosis of Other specified Bipolar and related disorder as assessed by specified MINI 7.0.2 modules.
What they're measuring
1
Abstinence
Timeframe: Last treatment visit at 10 weeks or earlier if participant was lost to follow up
2
Depression
Timeframe: Last treatment visit at 10 weeks or eariler if participant was lost to follow up
ā. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
ā. Participant considered by the investigator as unsuitable candidate for full participation in the study.
ā. Currently participating in individual psychotherapy
ā. Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study
ā. Rated on the Columbia-Suicide Severity Rating Scale113 at screening as in the past month having had active suicidal ideation with some intent to act or active suicidal ideation with specific plan and intent (indicated by answering "YES" on both Q3 and Q4, and/or 5) and/or endorsing "YES" to having engaged in preparatory acts towards or attempting suicide in the past 3 months (as indicated by answering "YES" to both parts of Q6)