Behavioral Activation for Depression in Pregnant Smokers

Overseen By Jan Blalock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Psychotic disorder, Bipolar disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant smokers dealing with depression quit smoking and remain smoke-free after childbirth. It will test two main approaches: Behavioral Activation Therapy, which improves mood and activity levels, and Tobacco Cessation Counseling, which guides quitting smoking. Participants will be divided into groups to test these methods through counseling sessions. Those who are pregnant, experiencing depression, and have smoked in the past 30 days might be a good fit for this trial. Participants must live in Texas and be willing to receive telehealth treatment. As an unphased trial, this study offers a unique opportunity to explore new methods for enhancing health and well-being during pregnancy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that any medication that could compromise participant safety or treatment may be a concern, so it's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Activation Therapy is generally easy to manage. Studies have found it can reduce symptoms of depression and anxiety, even during pregnancy. It proves effective both in-person and online, with few reports of negative effects.

For Tobacco Cessation Counseling, research supports its safety and effectiveness, particularly during pregnancy. Counseling increases quitting rates and is safer than continuing to smoke. This method avoids medications, enhancing its safety during pregnancy.

Both treatments have yielded positive results in the past, suggesting they are safe options for pregnant smokers dealing with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine Behavioral Activation (BA) Therapy and Tobacco Cessation Counseling, specifically tailored for pregnant smokers dealing with depression. Unlike standard treatments that typically focus solely on quitting smoking or addressing depression separately, this approach integrates mental health and smoking cessation support in a synchronized manner. Moreover, the use of smartphone videoconferencing makes the therapy more accessible and convenient, allowing participants to receive support from the comfort of their home. This innovative method aims to enhance engagement and effectiveness by addressing both the psychological and physical aspects of smoking cessation during pregnancy.

What evidence suggests that this trial's treatments could be effective for depression in pregnant smokers?

Research has shown that Behavioral Activation Therapy, which participants in this trial may receive, can help people quit smoking and improve their mood. One study found that this method was particularly helpful for smokers with depression, making it easier for them to stop smoking and feel less depressed. Another study found that combining Behavioral Activation with mobile health apps also improved success in quitting smoking.

For Tobacco Cessation Counseling, another treatment option in this trial, evidence suggests it can greatly assist pregnant women in quitting smoking. Studies have shown that counseling increases the chances of quitting during pregnancy. Specifically, pregnant women who received counseling were more likely to stop smoking compared to those who did not receive counseling. ^{1 2 6 7 8}

Who Is on the Research Team?

Jan Blalock

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Score ≥ 10 on the PHQ-9 at baseline.

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']

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Participants participate in focus group sessions to adapt and refine the delivery of behavioral activation therapy and health and wellness education

1-2 weeks

1 visit (virtual)

Treatment

Participants receive smoking cessation and behavioral activation or health and wellness counseling via smartphone videoconferencing

10 weeks

10 visits (virtual)

Postpartum Treatment

Participants continue with additional counseling sessions postpartum to support smoking cessation and manage depression

6 weeks

4 visits (virtual)

Follow-up

Participants are monitored for smoking cessation and depression outcomes postpartum

4 1/2 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation Therapy
• Discussion
• Health Education
• Questionnaire Administration
• Tobacco Cessation Counseling

Trial Overview 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.

How Is the Trial Designed?

Group I: Aim 4 Group IV (HW) Experimental Treatment 3 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.

Group II: Aim 4 Group III (BA) Experimental Treatment 3 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.

Group III: Aim 3 Group II (HW) Experimental Treatment 2 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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.

Group IV: Aim 3 Group I (BA) Experimental Treatment 2 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 smart phone videoconferencing and to conduct process evaluation of technical issues in use of smart phones.

Group V: Aim 1 and secondary aim 2 (focus group) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05044546

A Behavioral Activation Prenatal and Postpartum ... This study evaluates a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3108050/

Randomized Controlled Trial of Behavioral Activation ... Results suggest BATS is a promising intervention that may promote smoking cessation and improve depressive symptoms among underserved smokers of diverse ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11663802/

Behavioral Activation mHealth Application for Smoking ... At 8 weeks, 8.2% of the Actify! arm and 2.0% of the QuitGuide arm reported receiving both psychotherapy and medication for depression; 0.0% of the Actify arm ...

4. formative.jmir.org formative.jmir.org/2019/4/e13728/

A Behavioral Activation Mobile Health App for Smokers With ... Behavioral Activation Treatment for Depression (BAT-D) is a promising approach for improving smoking cessation outcomes among smokers with ...

5. humanfactors.jmir.org humanfactors.jmir.org/2024/1/e50098/

A Digital Behavioral Activation Intervention (JuNEX) for ... A Digital Behavioral Activation Intervention (JuNEX) for Pregnant Women With Subclinical Depression Symptoms: Explorative Co-Design Study.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858420/

Testing a Behavioral Activation Gaming App for ... This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant ...

7. formative.jmir.org formative.jmir.org/2024/1/e44029

Testing a Behavioral Activation Gaming App for Depression ... This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant ...

8. womensmentalhealth.org womensmentalhealth.org/posts/behavioral-activation-reduces-suicidal-ideation-in-perinatal-depression/

Behavioral Activation Reduces Suicidal Ideation in Women ... Behavioral activation significantly reduced suicidal ideation in women with perinatal depression, showing effectiveness whether delivered in-person or remotely ...