New hope for depressed pregnant smokers: mood program aims to help quit for good

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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