A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
Depression, Tobacco Use Disorder
About this trial
This is an interventional prevention trial for Depression
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for Aims 1, 3 and 4:
- Pregnant (or within 4 months post-partum for aim 1 only)
- Score ≥ 10 on the PHQ-9 at baseline.
- ≥ 18 years of age
- Have a telephone
- Self report smoking, even a puff, cigarettes, little cigars and/or cigarillos in the past 30 days.
- 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
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.
Inclusion criterion for Secondary Aim 2:
Women enrolled in the study who dropped out of the study during the first month of the postpartum treatment phase or women who completed at least 6 of the 8 postpartum treatment sessions Because study therapists will be asked to complete the WAI and acceptability of treatment ratings as part of Aim 4 work, they will be considered study participants and will provide verbal consent to complete these measures.
Inclusion criterion for Study Therapists
- Masters degree in psychology, social work, or other counseling degree
- Training in the delivery of psychotherapy and counseling interventions
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Aim 1 and secondary aim 2 (focus group)
Aim 3 Group I (BA)
Aim 3 Group II (HW)
Aim 4 Group III (BA)
Aim 4 Group IV (HW)
Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.
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.
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.
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.
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.