Behavioral intervention for depressed pregnant smokers

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

This study is testing a new program that helps pregnant women who smoke and are feeling depressed to quit smoking and improve their mood using video calls and an app.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05044546 on ClinicalTrials.gov

What this trial studies

This study evaluates a mood management and smoking cessation intervention specifically designed for depressed pregnant smokers during and after pregnancy. It involves qualitative interviews to adapt behavioral activation therapy and health education delivered via smartphone videoconferencing and an app. The intervention aims to help participants quit smoking and manage depression through a 10-week treatment course, followed by a preliminary randomized trial to assess its effectiveness and feasibility. The study will also explore barriers to participation and retention.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women or those within 4 months postpartum who are experiencing depression and have recently smoked.

Not a fit: Patients who are not currently pregnant or postpartum, or those without a history of smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and smoking cessation rates among pregnant smokers, benefiting both mothers and their babies.

How similar studies have performed: Other studies have shown promise in using behavioral interventions for smoking cessation and managing depression, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for Aims 1, 3 and 4:

1. Pregnant (or within 4 months post-partum for aim 1 only)
2. Score ≥ 10 on the PHQ-9 at baseline.
3. ≥ 18 years of age
4. Have a telephone
5. Self report smoking, even a puff, cigarettes, little cigars and/or cigarillos in the past 30 days.
6. 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
7. Able to speak and read English

Exclusion Criteria:

Exclusion criteria for Aims 1:

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)
2. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
3. 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.
4. 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.
5. Participant considered by the investigator as unsuitable candidate for full participation in the study.

Exclusion criteria for Aims 3 and 4:

1. Currently participating in individual psychotherapy
2. Currently participating in other smoking cessation treatments and refuses to refrain from use for the duration of the study
3. Currently using psychotropic medication
4. 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)
5. Have a lifetime or current diagnosis of Psychotic Disorder as assessed by specified Mini International Neuropsychiatric Interview (MINI) 7.0.2 modules.
6. 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.
7. 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.
8. Participant considered by the investigator as unsuitable candidate for full participation in the study.

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 Because study therapists will be asked to complete the WAI and acceptability of treatment ratings as part of Aim 4 work, they will be considered study participants and will provide verbal consent to complete these measures.

Inclusion criterion for Study Therapists

1. Masters degree in psychology, social work, or other counseling degree
2. Training in the delivery of psychotherapy and counseling interventions

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Jan Blalock, MD — M.D. Anderson Cancer Center
• Study coordinator: Jan Blalock, MD

Conditions: Depression, Tobacco Use Disorder