A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

Conditions

• Depression
• Tobacco Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Behavioral Activation Therapy — BEHAVIORAL
  Participate in BA counseling
• Discussion — PROCEDURE
  Participate in focus group
• Health Education — BEHAVIORAL
  Participate in health and wellness education counseling
• Questionnaire Administration — OTHER
  Ancillary studies
• Tobacco Cessation Counseling — OTHER
  Participate in smoking cessation counseling

Study Details

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.

Key Dates

Start date

Oct 19, 2021

Status verified

Jan 2026

Primary completion

Nov 22, 2024

Completion

Jan 31, 2027

Study Design

Enrollment

26 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.
• 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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.
• Experimental: Aim 4 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.
• Experimental: Aim 4 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.

Primary Outcome Measure

Abstinence [ Time Frame: Last treatment visit at 10 weeks or earlier if participant was lost to follow up ]

Locations (1)

Find similar trials in Houston, TX

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