A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

NCT05044546 | Active Not Recruiting Results

• 7 other identifiers: 2020-0972NCI-2021-07469P30CA016672R01DA014301R01MH076776R01MH087692R34DA048265
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (4)

• Abstinence

  Point-prevalence abstinence at last treatment visit at 10 weeks or earlier if ppt was lost to follow up defined as both a self-report of not smoking during the previous 7 days and a negative result from biochemical verification.

  Last treatment visit at 10 weeks or earlier if participant was lost to follow up

• Depression

  Depression as assessed using the Patient Health Questionnaire (PHQ-9) measure. The PHQ 9 is the major depressive episode scale from the Patient Health Questionnaire (PHQ). There are nine items on the Patient Health Questionnaire (PHQ-9). The PHQ-9 Depression Severity score is calculated by assigning score of 0, 1, 2, 3 to the response category of "not at all", "several days", "more than half, the days", and "nearly every day", respectively. The PHQ-9 total score for the nine items ranges from 0 to 27. The higher the value indicates a more severe score. The total score is a combination of the number of total symptoms experienced and the frequency of those symptoms over a two week period. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. There are no subscales on the PHQ-9

  Last treatment visit at 10 weeks or eariler if participant was lost to follow up

• Abstinence

  Point-prevalence abstinence at 4 ½ months postpartum follow-ups defined as both a self-report of not smoking during the previous 7 days and a negative result from biochemical verification.

  4 ½ months postpartum

• Depression

  Depression as assessed using the Patient Health Questionnaire (PHQ-9) measure. The PHQ 9 is the major depressive episode scale from the Patient Health Questionnaire (PHQ). There are nine items on the Patient Health Questionnaire (PHQ-9). The PHQ-9 Depression Severity score is calculated by assigning score of 0, 1, 2, 3 to the response category of "not at all", "several days", "more than half, the days", and "nearly every day", respectively. The PHQ-9 total score for the nine items ranges from 0 to 27. The higher the value indicates a more severe score. The total score is a combination of the number of total symptoms experienced and the frequency of those symptoms over a two week period. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. There are no subscales on the PHQ-9

  4 1/2 months postpartum

Study Arms (5)

Aim 1 and secondary aim 2 (focus group)

EXPERIMENTAL

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

Procedure: Discussion

Aim 3 Group I (BA)

EXPERIMENTAL

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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.

Behavioral: Behavioral Activation Therapy; Other: Tobacco Cessation Counseling

Aim 3 Group II (HW)

EXPERIMENTAL

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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.

Behavioral: Health Education; Other: Tobacco Cessation Counseling

Aim 4 Group III (BA)

EXPERIMENTAL

During the prenatal period, participants of 18-22 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling ad 45 minutes of behavioral activation counseling sessions. These women will have 16 weeks to complete their 10 individual sessions.

Behavioral: Behavioral Activation Therapy; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

Aim 4 Group IV (HW)

EXPERIMENTAL

During the prenatal period, participants of 18-22 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling and 45 minutes of health and wellness education counseling sessions. These women will have 16 weeks to complete their 10 individual sessions.

Behavioral: Health Education; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

Interventions

Tobacco Cessation Counseling OTHER

Participate in smoking cessation counseling

Aim 3 Group I (BA); Aim 3 Group II (HW); Aim 4 Group III (BA); Aim 4 Group IV (HW)

Behavioral Activation Therapy BEHAVIORAL

Participate in BA counseling

Also known as: BAT, Behavioral Activation

Aim 3 Group I (BA); Aim 4 Group III (BA)

Discussion PROCEDURE

Participate in focus group

Also known as: Discuss

Aim 1 and secondary aim 2 (focus group)

Health Education BEHAVIORAL

Participate in health and wellness education counseling

Aim 3 Group II (HW); Aim 4 Group IV (HW)

Questionnaire Administration OTHER

Ancillary studies

Aim 4 Group III (BA); Aim 4 Group IV (HW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant (or within 4 months post-partum for aim 1 only)
• 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.
• ≥ 18 years of age
• Have a telephone
• Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
• Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum
• Able to speak and read English
• Subjects must report a current residence in the State of Texas
• 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.
• ≥ 18 years of age
• Have an address and telephone number where they may be reached
• Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
• Gestational age between 12 to 34 weeks
• Able to speak and follow verbal and written instructions in English
• Subjects must report a current residence in the State of Texas and must not have plans to move out of the state in the next 2.5 months

You may not qualify if:

• 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.
• Currently participating in individual psychotherapy
• Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study
• 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.
• 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.
• ≥ 18 years of age
• Have an address and telephone number where they may be reached

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depression; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jennifer Minnix
• Organization: MD Anderson Cancer Center

jminnix@mdanderson.org

713-792-0476

Study Officials

• Jennifer A Minnix, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 14, 2021
• Study Start: October 19, 2021
• Primary Completion: November 22, 2024
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Locations

US (1)