A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

Overview

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.

Full Title of Study: “Pilot Study to Evaluate a Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2023

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.

Interventions

  • Behavioral: Behavioral Activation Therapy
    • Participate in BA counseling
  • Procedure: Discussion
    • Participate in focus group
  • Behavioral: Health Education
    • Participate in health and wellness education counseling
  • Other: Questionnaire Administration
    • Ancillary studies
  • Other: Tobacco Cessation Counseling
    • Participate in smoking cessation counseling

Arms, Groups and Cohorts

  • Experimental: Aim 1 and secondary aim 2 (focus group)
    • Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.
  • Experimental: Aim 3 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.
  • Experimental: Aim 3 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.
  • Experimental: Aim 4 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.
  • Experimental: Aim 4 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.

Clinical Trial Outcome Measures

Primary Measures

  • Focus group
    • Time Frame: Up to 6 months postpartum
    • 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).

Participating in This Clinical Trial

Inclusion Criteria

INCLUSION CRITERIA FOR AIMS 1, 3 AND 4

  • Pregnant – Score >= 10 on the Patient Health Questionnaire (PHQ)-9 at baseline – >= 18 years of age – Have a telephone – Self report smoking 1 or more cigarettes per day – For Aim 1, half of women will be at gestational age up to 28 weeks and half will be within 4 months postpartum; for Aim 3, women will be at gestational age between 32 to 36 weeks; For Aim 4, women will be at gestational age up to 28 weeks – Able to speak and read English – 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 – INCLUSION CRITERION FOR STUDY THERAPISTS – Master's degree in psychology, social work, or other counseling degree – Training in the delivery of psychotherapy and counseling interventions Exclusion Criteria:

EXCLUSION CRITERIA FOR AIMS 1, 3 AND 4

  • Currently participating in psychotherapy – Currently participating in other smoking cessation treatments – Currently using psychotropic medication – Rated on the Columbia-Suicide Severity Rating Scale at screening as having active suicidal ideation with some intent to act or active suicidal ideation with specific plan and intent – Have psychological or cognitive conditions that put them at risk of harm or interfere with their ability to participate in the study, as indicated by information that is gathered from the Psychiatric Diagnostic Screening Questionnaire (PDSQ)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Blalock, Principal Investigator, M.D. Anderson Cancer Center

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