ACTIVE_NOT_RECRUITING

A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-19

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05044546

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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
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

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

Contacts and Locations

Principal Investigator

Jan Blalock

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Jan Blalock, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2021-10-19

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-10-19

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Depression
Tobacco Use Disorder