A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044546
• Other study ID #: 2020-0972
• Secondary ID: NCI-2021-0746920
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Jan Blalock, MD
• Phone: 713-745-1728
• Email: jablaloc[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 smartphone videoconferencing, a BA and HW smartphone 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 smartphone videoconferencing, of a 10-week treatment course of BA and HW and conduct process evaluation of technical issues in the use of smartphones, 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 6 months postpartum. (Stage IB) IIIb. Effect of BA on depression at 6 months postpartum. (Stage IB) IIIc. Feasibility of acceptance of the smartphone 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 breath carbon monoxide samples collected remotely for biochemical verification of self-reported abstinence at 6 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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

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 smartphone videoconferencing and to conduct process evaluation of technical issues in use of smartphones.

AIM 4: Participants are randomized to 1 of 2 groups.

GROUP III (BA): 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 IV (HW): 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Tobacco Use Disorder

Intervention

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
• Tobacco Cessation Counseling
Participate in smoking cessation counseling

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focus group	With Dr. Blalock as cross-reader, Dr. Villarreal will work with readers (i.e., AIM staff) to code transcripts for overarching themes, supported by NVivo11 qualitative data analysis software, using conventional grounded theory methodology (identifying categories that capture the basic aspects of the group's experience).	Up to 6 months postpartum

External Links

•   MD Anderson Cancer Center