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Behavioral Activation for Depression in Pregnant Smokers
N/A
Recruiting
Led By Jan Blalock
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months postpartum
Awards & highlights
Study Summary
This trial may help pregnant smokers who are depressed quit smoking and stay smoke-free after their babies are born.
Who is the study for?
This trial is for pregnant smokers aged 18 or older who are experiencing depression, as indicated by a score of ≥10 on the PHQ-9. They must be between 32 to 36 weeks gestational age or within 4 months post-partum, able to speak and read English, and have access to a telephone. Excluded are those with severe mental health conditions like bipolar disorder or psychotic disorders, current psychotherapy participants, users of psychotropic medication, and anyone deemed unsuitable by the investigator.Check my eligibility
What is being tested?
The study tests a smoking cessation intervention that includes mood management through Behavioral Activation Therapy along with health education for depressed pregnant smokers. It aims to help them quit smoking during pregnancy and maintain their smoke-free status after childbirth.See study design
What are the potential side effects?
Since this trial involves discussion-based therapy and educational interventions rather than medications, traditional side effects associated with drugs are not expected. However, discussing sensitive topics may cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am 18 years old or older.
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I have smoked at least once in the past 30 days.
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I am either up to 36 weeks pregnant or within 4 months after giving birth.
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I have a Masters in psychology, social work, or counseling and am trained in psychotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Focus group
Trial Design
5Treatment groups
Experimental Treatment
Group I: Aim 4 Group IV (HW)Experimental Treatment3 Interventions
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.
Group II: Aim 4 Group III (BA)Experimental Treatment3 Interventions
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 III: Aim 3 Group II (HW)Experimental Treatment2 Interventions
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.
Group IV: Aim 3 Group I (BA)Experimental Treatment2 Interventions
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 V: Aim 1 and secondary aim 2 (focus group)Experimental Treatment1 Intervention
Participants participate in focus group over 60-90 minutes. Participants who completed and dropped out of postpartum treatment also participate in a focus group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2021
N/A
~130
Health Education
2014
Completed Phase 3
~4000
Behavioral Activation Therapy
2018
Completed Phase 4
~700
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,350 Total Patients Enrolled
11 Trials studying Depression
701,270 Patients Enrolled for Depression
Jan BlalockPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
54,158 Total Patients Enrolled
Jan Blalock, MDPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have smoked, even a puff, cigarettes, little cigars or cigarillos in the past 30 days.I am either up to 36 weeks pregnant or within 4 months after giving birth.I have a Masters in psychology, social work, or counseling and am trained in psychotherapy.You are between 32 and 36 weeks pregnant.I am trained in providing psychotherapy and counseling.I am 18 years old or older.You must have a telephone.\nI am 18 years old or older.I have smoked at least once in the past 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Aim 3 Group II (HW)
- Group 2: Aim 4 Group IV (HW)
- Group 3: Aim 4 Group III (BA)
- Group 4: Aim 1 and secondary aim 2 (focus group)
- Group 5: Aim 3 Group I (BA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently open for this investigation?
"Affirmative. Clinicaltrials.gov provides evidence that this research initiative, first announced on October 19th 2021, is looking for participants to join the project. The study requires 99 people from a single clinical trial site."
Answered by AI
What is the current cohort size of this therapeutic experiment?
"Affirmative. According to clinicaltrials.gov, the recruitment for this research project has begun since October 19th 2021 and was updated lastly on August 18th 2022. A total of 99 individuals are sought from a single trial site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Because I want to fix what is wrong with me. I’ve tried different prescriptions and they don’t help.
PatientReceived 2+ prior treatments
I am applying for this trial to get help with my condition.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- M D Anderson Cancer Center: < 48 hours
Average response time
- < 2 Days
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