Behavioral Activation for Depression in Pregnant Smokers

Recruiting in Palo Alto (17 mi)

Overseen byJan Blalock, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for pregnant smokers aged 18 or older who are experiencing depression, as indicated by a score of ≥10 on the PHQ-9. They must be between 32 to 36 weeks gestational age or within 4 months post-partum, able to speak and read English, and have access to a telephone. Excluded are those with severe mental health conditions like bipolar disorder or psychotic disorders, current psychotherapy participants, users of psychotropic medication, and anyone deemed unsuitable by the investigator.

Inclusion Criteria

Score ≥ 10 on the PHQ-9 at baseline.

Aim 1 Criteria: Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum Aim 3 Criteria: gestational age between 32 to 36 weeks Aim 4 Criteria: gestational age up to 28 weeks

Able to speak and read English

See 16 more

Exclusion Criteria

Exclusion criteria for Aims 1: 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)', 'Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules', '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', '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', 'Participant considered by the investigator as unsuitable candidate for full participation in the study', 'Exclusion criteria for Aims 3 and 4: Currently participating in individual psychotherapy', 'Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study', 'Currently using psychotropic medication', '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)', 'Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules', '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', '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', 'Participant considered by the investigator as unsuitable candidate for full participation in the study']

Treatment Details

Interventions

Behavioral Activation Therapy (Behavioral Intervention)
Discussion (Behavioral Intervention)
Health Education (Behavioral Intervention)
Questionnaire Administration (Behavioral Intervention)
Tobacco Cessation Counseling (Behavioral Intervention)

Trial OverviewThe study tests a smoking cessation intervention that includes mood management through Behavioral Activation Therapy along with health education for depressed pregnant smokers. It aims to help them quit smoking during pregnancy and maintain their smoke-free status after childbirth.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Aim 4 Group IV (HW)Experimental Treatment3 Interventions

Participants participate in 8-14 smoking cessation counseling over 15 minutes and health and wellness education counseling sessions over 45 minutes every 2-3 weeks till the end of the pregnancy. Following birth, participants also participate in 4 additional sessions within the first 6 weeks, then that last 4 evenly distributed across 10 weeks.

Group II: Aim 4 Group III (BA)Experimental Treatment3 Interventions

Participants participate in 8-14 smoking cessation counseling over 15 minutes and BA counseling sessions over 45 minutes every 2-3 weeks till the end of the pregnancy. Following birth, participants also participate in 4 additional sessions within the first 6 weeks, then that last 4 evenly distributed across 10 weeks.

Group III: Aim 3 Group II (HW)Experimental Treatment2 Interventions

Participants participate in smoking cessation counseling over 15 minutes and health and wellness education counseling sessions over 45 minutes once a week for 10 weeks to pilot test delivery via smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

Group IV: Aim 3 Group I (BA)Experimental Treatment2 Interventions

Participants participate in smoking cessation counseling over 15 minutes and BA counseling sessions over 45 minutes once a week for 10 weeks to pilot test delivery via smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

Group V: Aim 1 and secondary aim 2 (focus group)Experimental Treatment1 Intervention

Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.