A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

January 20, 2026 updated by: M.D. Anderson Cancer Center

Pilot Study to Evaluate a Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. Conduct qualitative group interviews with depressed pregnant smokers and depressed smokers within the first 4 months of the postpartum period, to adapt and refine the delivery of behavioral activation therapy (BA) and health and wellness education (HW) via smart phone videoconferencing, a BA and HW smart phone application (app) including supportive smoking cessation messages in the prenatal and postpartum periods. (Stage IA) II. Adapt BA and smoking cessation counseling manuals, BA and HW app and content, and treatment integrity rating scales for the prenatal and postpartum period. (Stage IA) III. Pilot test the delivery, via smart phone videoconferencing, of a 10-week treatment course of BA and HW and conduct process evaluation of technical issues in the use of smart phones, barriers to participation and retention; completion of study assessments, and; adequacy of procedures for addressing psychiatric emergencies. (Stage IA)

III. Conduct a preliminary randomized trial with depressed pregnant smokers comparing BA to HW to evaluate:

IIIa. Effect of BA on abstinence at 4 1/2 months postpartum. (Stage IB) IIIb. Effect of BA on depression at 4 1/2 months postpartum. (Stage IB) IIIc. Feasibility of acceptance of the smart phone delivery of BA and HW, and assessment components indicated by a) retention; b) completion of prenatal and postpartum sessions; c) completion of study assessments, d) strength of therapeutic alliance from both the participant and therapist perspective; e) participant and therapist ratings on satisfaction questionnaire. (Stage IB) IIId. Feasibility of study procedures as indicated by a) percentage of sessions interrupted by technical difficulties, and; b) percentage of urine cotinine tests and/or anabasine tests received for biochemical verification of self-reported abstinence at 4 1/2 months postpartum. (Stage IB)

SECONDARY OBJECTIVES:

I. Evaluate change in hypothesized treatment mechanisms including positive affect, negative affect, and cognitive function in relation to treatment effects on smoking and depression. (Stage IB) II. Conduct qualitative interviews with women who completed and did not complete postpartum treatment to assess a) barriers to completing treatment sessions; b) usefulness of postpartum treatment; c) suggestions for decreasing barriers and improving treatment acceptability, and; d) relevant experiences unexpected by participants and researchers. (Stage IB)

OUTLINE:

AIM 1 AND SECONDARY AIM 2: Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.

AIM 3: Participants are assigned to 1 of 2 groups.

GROUP I (BA): 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.

GROUP II (HW): 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.

AIM 4: Participants are randomized to 1 of 2 groups.

GROUP III (BA): 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.

During the prenatal period, participants of 23-32 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling and 45 minutes of behavioral activation counseling sessions. These women will have 12 weeks to complete their 10 individual sessions.

We may do additional check in calls or text communications with participants to maintain engagement between prenatal and postpartum treatment sessions.

Following birth, women may have up to a month break before resuming individual sessions, though have the option to resume earlier if preferred. Women will receive an additional 4counseling sessions in postpartum over 6 weeks. The participants will complete 1 follow up visit that occurs 4 ½ months postpartum.

GROUP IV (HW): 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.

During the prenatal period, participants of 23-32 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 12 weeks to complete their 10 individual sessions.

We may do additional check in calls or text communications with participants to maintain engagement between prenatal and postpartum treatment sessions.

Following birth, women may have up to a month break before resuming individual sessions, though have the option to resume earlier if preferred. Women will receive an additional 4counseling sessions in postpartum over 6 weeks. The participants will complete 1 follow up visit that occurs 4 ½ months postpartum.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Inclusion criteria for Aim 1

  1. Pregnant (or within 4 months post-partum for aim 1 only)
  2. 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.
  3. ≥ 18 years of age
  4. Have a telephone
  5. Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
  6. Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum
  7. Able to speak and read English
  8. Subjects must report a current residence in the State of Texas

Eligibility Criteria: AIM 3 Inclusion criteria for Aims 3

  1. 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.
  2. ≥ 18 years of age
  3. Have an address and telephone number where they may be reached
  4. Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
  5. Gestational age between 12 to 34 weeks
  6. Able to speak and follow verbal and written instructions in English
  7. 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
  8. Subjects referred directly from UT Health providers, the provider or designee will confirm pregnancy status through their electronic health record prior to the referral. Subjects referred by any other means will confirm positive pregnancy status through an at-home test.
  9. Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
  10. Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
  11. Provide informed consent and agree to all assessments and study procedures

Exclusion Criteria:

Exclusion criteria for Aims 1

  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)
  2. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
  3. 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.
  4. 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.
  5. Participant considered by the investigator as unsuitable candidate for full participation in the study.

Exclusion criteria for Aim 3

  1. Currently participating in individual psychotherapy
  2. Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study
  3. 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)
  4. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
  5. 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.
  6. 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.
  7. Participant considered by the investigator as unsuitable candidate for full participation in the study.

Eligibility Criteria: AIM 4 Inclusion criteria for AIM 4

  1. 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.
  2. ≥ 18 years of age
  3. Have an address and telephone number where they may be reached
  4. Self report smoking, even a puff, cigarettes, little cigars and/or Cigarillos in the past 30 days.
  5. Gestational age between 18to 32 weeks
  6. Able to speak and follow verbal and written instructions in English
  7. 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 7-8 months
  8. Subjects will confirm positive pregnancy status through study provided pregnancy test or provide paperwork verifying pregnancy status if the pregnancy test is inconclusive
  9. Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
  10. Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
  11. Provide informed consent and agree to all assessments and study procedures
  12. Interested in treatment that might change smoking behavior or help them quit smoking
  13. Be the only participant in their household currently receiving treatment on this protocol

Exclusion criteria for Aim 4

  1. Currently participating in individual psychotherapy
  2. Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study
  3. 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)
  4. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
  5. 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.
  6. 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.
  7. Participant considered by the investigator as unsuitable candidate for full participation in the study.

Inclusion criterion for Secondary Aim 2, Stage IB 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 3 of the 4 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

  1. Masters degree in psychology, social work, or other counseling degree
  2. Training in the delivery of psychotherapy and counseling interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aim 1 and secondary aim 2 (focus group)
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
Participate in focus group
Other Names:
  • Discuss
Experimental: Aim 3 Group I (BA)
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
Participate in BA counseling
Other Names:
  • BAT
  • Behavioral Activation
Other: Tobacco Cessation Counseling
Participate in smoking cessation counseling
Experimental: Aim 3 Group II (HW)
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.
Other: Tobacco Cessation Counseling
Participate in smoking cessation counseling
Behavioral: Health Education
Participate in health and wellness education counseling
Experimental: Aim 4 Group III (BA)
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.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Behavioral Activation Therapy
Participate in BA counseling
Other Names:
  • BAT
  • Behavioral Activation
Other: Tobacco Cessation Counseling
Participate in smoking cessation counseling
Experimental: Aim 4 Group IV (HW)
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.
Other: Questionnaire Administration
Ancillary studies
Other: Tobacco Cessation Counseling
Participate in smoking cessation counseling
Behavioral: Health Education
Participate in health and wellness education counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: Last treatment visit at 10 weeks or earlier if participant was lost to follow up
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
Time Frame: Last treatment visit at 10 weeks or eariler if participant was lost to follow up
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
Time Frame: 4 ½ months postpartum
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
Time Frame: 4 1/2 months postpartum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer A Minnix, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0972 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2021-07469 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01DA014301 (U.S. NIH Grant/Contract)
  • R01MH076776 (U.S. NIH Grant/Contract)
  • R01MH087692 (U.S. NIH Grant/Contract)
  • R34DA048265 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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