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A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

Primary Purpose

Depression, Tobacco Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy
Discussion
Health Education
Questionnaire Administration
Tobacco Cessation Counseling
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria for Aims 1, 3 and 4:

  1. Pregnant (or within 4 months post-partum for aim 1 only)
  2. Score ≥ 10 on the PHQ-9 at baseline.
  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. Aim 1 Criteria: Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum Aim 3 Criteria: gestational age between 32 to 36 weeks Aim 4 Criteria: gestational age up to 28 weeks
  7. Able to speak and read English

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 Aims 3 and 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. Currently using psychotropic medication
  4. 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)
  5. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
  6. 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.
  7. 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.
  8. Participant considered by the investigator as unsuitable candidate for full participation in the study.

Inclusion criterion for Secondary Aim 2:

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 6 of the 8 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Aim 1 and secondary aim 2 (focus group)

Aim 3 Group I (BA)

Aim 3 Group II (HW)

Aim 4 Group III (BA)

Aim 4 Group IV (HW)

Arm Description

Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.

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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

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, then that last 4 evenly distributed across 10 weeks.

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, then that last 4 evenly distributed across 10 weeks.

Outcomes

Primary Outcome Measures

Focus group
With Dr. Blalock as cross-reader, Dr. Villarreal will work with readers (i.e., AIM staff) to code transcripts for overarching themes, supported by NVivo11 qualitative data analysis software, using conventional grounded theory methodology (identifying categories that capture the basic aspects of the group's experience).

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
September 12, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05044546
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 smartphone videoconferencing, a BA and HW smartphone 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 smartphone videoconferencing, of a 10-week treatment course of BA and HW and conduct process evaluation of technical issues in the use of smartphones, 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 6 months postpartum. (Stage IB) IIIb. Effect of BA on depression at 6 months postpartum. (Stage IB) IIIc. Feasibility of acceptance of the smartphone 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 breath carbon monoxide samples collected remotely for biochemical verification of self-reported abstinence at 6 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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones. 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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones. 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, then that last 4 evenly distributed across 10 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, then that last 4 evenly distributed across 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Tobacco Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1 and secondary aim 2 (focus group)
Arm Type
Experimental
Arm Description
Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.
Arm Title
Aim 3 Group I (BA)
Arm Type
Experimental
Arm Description
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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.
Arm Title
Aim 3 Group II (HW)
Arm Type
Experimental
Arm Description
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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.
Arm Title
Aim 4 Group III (BA)
Arm Type
Experimental
Arm Description
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, then that last 4 evenly distributed across 10 weeks.
Arm Title
Aim 4 Group IV (HW)
Arm Type
Experimental
Arm Description
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, then that last 4 evenly distributed across 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy
Other Intervention Name(s)
BAT, Behavioral Activation
Intervention Description
Participate in BA counseling
Intervention Type
Procedure
Intervention Name(s)
Discussion
Other Intervention Name(s)
Discuss
Intervention Description
Participate in focus group
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Participate in health and wellness education counseling
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Tobacco Cessation Counseling
Intervention Description
Participate in smoking cessation counseling
Primary Outcome Measure Information:
Title
Focus group
Description
With Dr. Blalock as cross-reader, Dr. Villarreal will work with readers (i.e., AIM staff) to code transcripts for overarching themes, supported by NVivo11 qualitative data analysis software, using conventional grounded theory methodology (identifying categories that capture the basic aspects of the group's experience).
Time Frame
Up to 6 months postpartum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for Aims 1, 3 and 4: Pregnant (or within 4 months post-partum for aim 1 only) Score ≥ 10 on the PHQ-9 at baseline. ≥ 18 years of age Have a telephone Self report smoking, even a puff, cigarettes, little cigars and/or cigarillos in the past 30 days. Aim 1 Criteria: Approximately two thirds of the sample will be gestational age up to 36 weeks, and approximately one third will be within 4 months postpartum Aim 3 Criteria: gestational age between 32 to 36 weeks Aim 4 Criteria: gestational age up to 28 weeks Able to speak and read English Exclusion Criteria: Exclusion criteria for Aims 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) 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. Exclusion criteria for Aims 3 and 4: Currently participating in individual psychotherapy Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study Currently using psychotropic medication 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: 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 6 of the 8 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 Masters degree in psychology, social work, or other counseling degree Training in the delivery of psychotherapy and counseling interventions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Blalock, MD
Phone
713-745-1728
Email
jablaloc@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Blalock, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Blalock, MD
Phone
713-745-1728
Email
jablaloc@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jan Blalock, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

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