Clinical trial NCT05044546: A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
Official title: Pilot Study to Evaluate a Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Tobacco Use Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2021-09-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth. This study may help pregnant smokers who are experiencing depression quit smoking and stay smoke-free after their babies are born.

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): Participants participate in 8-14 smoking cessation counseling over 15 minutes and BA counseling sessions over 45 minutes every 2-3 weeks till the end of the pregnancy. Following birth, participants also participate in 4 additional sessions within the first 6 weeks.

GROUP IV (HW): Participants participate in 8-14 smoking cessation counseling over 15 minutes and health and wellness education counseling sessions over 45 minutes every 2-3 weeks till the end of the pregnancy. Following birth, participants also participate in 4 additional sessions within the first 6 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jan Blalock
role: PRINCIPAL_INVESTIGATOR
References: