DepressionNCT05044546
A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
A study testing Behavioral Activation Therapy, Discussion and Health Education in people with Depression and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Tobacco Use Disorder
- What is being tested?
- Behavioral Activation Therapy, Discussion and Health Education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Able to speak and read English
- Subjects must report a current residence in the State of Texas
- Eligibility Criteria: AIM 3 Inclusion criteria for Aims 3
- 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
- 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.
- Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
- Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
- Provide informed consent and agree to all assessments and study procedures
- Masters degree in psychology, social work, or other counseling degree
- Training in the delivery of psychotherapy and counseling interventions
Who cannot join
- 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
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- 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.
- Eligibility Criteria: AIM 4 Inclusion criteria for AIM 4
- 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 18to 32 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 7-8 months
- Subjects will confirm positive pregnancy status through study provided pregnancy test or provide paperwork verifying pregnancy status if the pregnancy test is inconclusive
- Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
- Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
- Provide informed consent and agree to all assessments and study procedures
- Interested in treatment that might change smoking behavior or help them quit smoking
- Be the only participant in their household currently receiving treatment on this protocol
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Depression, Tobacco Use Disorder
- Being tested
- Behavioral Activation Therapy, Discussion, Health Education, Questionnaire Administration, Tobacco Cessation Counseling
- Medical subject headings
- Depression, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TherapyBehavioural
Also called BAT, Behavioral Activation
Participate in BA counseling
DiscussionProcedure or surgery
Also called Discuss
Participate in focus group
Health EducationBehavioural
Participate in health and wellness education counseling
Questionnaire AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Participate in smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Health Education; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 4 1/2 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start19 Oct 2021
- Primary completion22 Nov 2024
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Minnix, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044546
- Sponsor's protocol ID
- 2020-0972
- Other IDs
- NCI-2021-07469, 2020-0972, P30CA016672, R01DA014301, R01MH076776, R01MH087692, R34DA048265
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2021
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate a Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
- ClinicalTrials.gov ID
- NCT05044546
- Acronym / sponsor ID
- 2020-0972
- Conditions
- Depression, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aim 1 and secondary aim 2 (focus group) | Experimental | Procedure: DiscussionParticipants 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 Group I (BA) | Experimental | Behavioral: Behavioral Activation Therapy, Other: Tobacco Cessation CounselingParticipants 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. |
| Aim 3 Group II (HW) | Experimental | Behavioral: Health Education, Other: Tobacco Cessation CounselingParticipants 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 Group III (BA) | Experimental | Behavioral: Behavioral Activation Therapy, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingDuring 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. |
| Aim 4 Group IV (HW) | Experimental | Behavioral: Health Education, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TherapyAlso: BAT, Behavioral ActivationParticipate in BA counseling | Behavioural | Aim 3 Group I (BA), Aim 4 Group III (BA) |
| DiscussionAlso: DiscussParticipate in focus group | Procedure or surgery | Aim 1 and secondary aim 2 (focus group) |
| Health EducationParticipate in health and wellness education counseling | Behavioural | Aim 3 Group II (HW), Aim 4 Group IV (HW) |
| Questionnaire AdministrationAncillary studies | Other | Aim 4 Group III (BA), Aim 4 Group IV (HW) |
| Tobacco Cessation CounselingParticipate in smoking cessation counseling | Other | Aim 3 Group I (BA), Aim 3 Group II (HW), Aim 4 Group III (BA), Aim 4 Group IV (HW) |
Primary outcome
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.
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
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Minnix, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Therapy, Discussion and Health Education in people with Depression and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: Last treatment visit at 10 weeks or earlier if participant was lost to follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.