NCT05044546

A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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): During the prenatal period, participants of 18-22 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling ad 45 minutes of behavioral activation counseling sessions. These women will have 16 weeks to complete their 10 individual sessions. During the prenatal period, participants of 23-32 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling and 45 minutes of behavioral activation counseling sessions. These women will have 12 weeks to complete their 10 individual sessions. We may do additional check in calls or text communications with participants to maintain engagement between prenatal and postpartum treatment sessions. Following birth, women may have up to a month break before resuming individual sessions, though have the option to resume earlier if preferred. Women will receive an additional 4counseling sessions in postpartum over 6 weeks. The participants will complete 1 follow up visit that occurs 4 ½ months postpartum. GROUP IV (HW): During the prenatal period, participants of 18-22 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling and 45 minutes of health and wellness education counseling sessions. These women will have 16 weeks to complete their 10 individual sessions. During the prenatal period, participants of 23-32 weeks gestational age will receive 10 individual sessions with 15 minutes of smoking cessation counseling and 45 minutes of health and wellness education counseling sessions. These women will have 12 weeks to complete their 10 individual sessions. We may do additional check in calls or text communications with participants to maintain engagement between prenatal and postpartum treatment sessions. Following birth, women may have up to a month break before resuming individual sessions, though have the option to resume earlier if preferred. Women will receive an additional 4counseling sessions in postpartum over 6 weeks. The participants will complete 1 follow up visit that occurs 4 ½ months postpartum.

Conditions

• Depression
• Tobacco Use Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-11-22
• Completion: 2027-01-31
• First posted: 2021-09-14
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

1 site across 1 country: United States