Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention

Stress Clinical Trial

Official title:

Examining the Feasibility and Acceptability of a Novel App-based Cognitive Behavioral Therapy Intervention for Preventing Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365645
• Other study ID #: 2138752
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers & Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention.

Description:

Overall, 10-15% of women are diagnosed with postpartum depression (PPD). Though the most significant risk factor for PPD is a history of depression or prior PPD, rates of PPD are as high as 25% among women without prior depression or PPD but with personal risk factors such as reporting little social support or food insecurity during pregnancy and structural factors such as being unmarried. There are profound maternal and pediatric consequences of postpartum mental illness: untreated PPD is associated with maternal morbidity9-11 and impaired child cognitive development. As such, the American College of Obstetricians & Gynecologists recommends screening all postpartum women for PPD.

There are, however, several structural barriers to the implementation of this recommendation. First, to be screened for PPD, women must attend postpartum visits, and <60% of women do so. Barriers such as lack of childcare or transportation reduce postpartum visit attendance and disproportionately affect low-income women. Second, pregnancy-related health insurance ends at 60 days postpartum, but PPD can persist for months after delivery, leaving low-income women without subsidized access to screening or treatment. Third, unlike those with known psychiatric illness, many pregnant women without prior mental illness do not receive antenatal mental health screening (unless via universal screening) leading to delayed recognition of and diagnosis of depressive symptoms. Tools to overcome these barriers are sorely needed, particularly for those with the least access who currently fall through the cracks.

Therapy preventing PPD delivered via smartphone applications (apps) may be such a tool. The USPSTF concluded that Cognitive Behavioral Therapy (CBT) - which teaches coping skills to modify maladaptive conditions, behaviors, and physiological responses24, 25 - reduces rates of PPD by 49%. The USPSTF highlighted the Mothers and Babies (MB) CBT program for reducing rates of PPD by 53% among low-income women of color. MB was originally designed as a preventive in-person therapy for low-income English- and Spanish-speaking women without psychiatric illness and contains one parenting education module and multiple CBT modules. MB has started to become a digital health intervention: online MB has been shown to be feasible, and text-message-base MB has been examined in one small study. However, to our knowledge, no studies of app-based MB exist. Online or text-message MB may increase access, but participation with an app would likely be higher for several reasons. Individuals are more likely to have smartphones than internet access: 96% of those aged 18-29 years own smartphones. Additionally, apps provide two advantages compared to other digital health programs: (1) App-based content is accessible without cellular or internet service, (2) Apps serve as just-in-time adaptive interventions,35-37 delivering support tailored to individual behaviors. Thus, app-based MB may decrease PPD while overcoming barriers to care.

Over the last two years, this NIH-funded study has utilized evidence-based user-centered digital intervention design techniques and qualitative research methodology to adapt the MB curriculum into a novel smartphone application, M.Bapp. Similar to MB, M.Bapp contains one parenting education module and multiple CBT-based modules.We now propose a pilot randomized control trial to examine the feasibility, acceptability, and preliminary estimates of effects of the full MB program via M.Bapp (intervention) when compared to app-based digital parenting education (an attention control group). Our long-term goal is to use M.Bapp to prevent PPD among perinatal women at high-risk for the condition due to those with structural or personal risk factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• English- or Spanish-speaking

• maternal age >18 years old

• smartphone ownership

• receiving prenatal care from a resident or nurse-practitioner/midwifery clinic at the Obstetric and Gynecologic Care Center at WIH

• plan to receive postpartum care at the OGCC,

• gestational age =32 weeks'.

Exclusion Criteria:

• Active diagnosis or history within five years of depression, anxiety, or other psychiatric condition, as documented in the electronic medical record

• Endorsing active suicidality on intake survey or screening positive on EPDS (=10) or Patient Health Questionnaire (PHQ)-9 (=10) or GAD-7 (=8)

• prisoners

• inability to consent.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Anxiety
• Postpartum Depression
• Stress

Intervention

Behavioral:
• M.Bapp
Please see experimental group description.
• App-based parenting education
Please see active comparator group description.

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	De novo psychiatric diagnosis	Initiation of antidepressant or other psychotropic medication during study period	Within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
Other	Screening positive on study survey	Screening positive for anxiety, depression, or stress	Within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
Primary	Feasibility	50% of those who are eligible based on prescreening and who are approached to participate consent to participate and 80% of those randomized to M.Bapp view at least 5 of the 10 modules	Randomization and six months postpartum
Primary	Acceptability	Scoring at least 80% on two well-validated scales: the System Usability Scale (focusing on perceived usability of technology) and the Client Satisfaction Questionnaire (focusing on satisfaction with mental health therapy). These surveys will also contain questions covering additional themes about participant experience with the study intervention (either M.Bapp or app-based parenting education)-(1) helpfulness; (2) satisfaction; and (3) ease of interface with technical aspects of the program.	Six months postpartum
Secondary	Inventory for Depression Scale	30-item Score from 0 to 84. Screen positive: score =26 or suicidal ideation	Baseline (32-36 weeks' gestation), within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
Secondary	General Anxiety Disorder-7	7-item self-report on anxiety symptoms	Baseline (32-36 weeks' gestation), within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
Secondary	Perceived Stress-Scale 4	4-item self-report on stress symptoms	Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
Secondary	Dyadic Adjustment Scale	7-item survey measuring relationship satisfaction, decision-making and cohesion	Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
Secondary	UCLA Loneliness Scale	20-item survey measuring loneliness	Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
Secondary	Frequency of Mothers and Babies Skills Use	10-item survey created by MB to evaluate perceived helpfulness of intervention	6 months postpartum