New Moms Mood Tracking & Wellbeing

Not Applicable

Completed

• Conditions: Depression; Perinatal Depression; Pregnancy Related; Anxiety
• Interventions: Other: Perinatal Psychiatric Care; Behavioral: Online therapy with coaching within STAND; Behavioral: Clinical care within STAND

• Registration Number: NCT05056454
• Lead Sponsor: University of California, Los Angeles

Brief Summary

New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms will be eligible to participate in a treatment study. Women who are eligible for the treatment study will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians for medication management and supportive therapy. In STAND, participants will be allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

• Women who are between week 28 of their pregnancy and 6 months postpartum and are receiving care at a UCLA OB-GYN clinic
• Fluent in English
• Current endorsement of moderate or higher depression on the Edinburgh Postnatal Depression Scale (EPDS, => 11 sum score), administered by the treating OB-GYN physician or study staff
• Not currently in individual treatment for a behavioral or emotional problem (e.g., anxiety, depression)
• Willingness to follow study procedures
• Willingness to participate in treatment through the study and follow all study procedures, including provide HIPAA Authorization for research
• Has access to the internet via mobile or desktop device

Exclusion Criteria

• Are currently receiving treatment by a therapist or a psychiatrist
• Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months, combined with high ratings on self-reported negative urgency)
• Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
• Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
• Neurological conditions
• Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
• Cognitive impairment (e.g., developmental disability, dementia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perinatal Psychiatric Care	Perinatal Psychiatric Care	This treatment condition is modelled after the psychiatry-delivered treatment usually provided at the Maternal Outpatient Mental Health Services (MOMS) Clinic associated with the UCLA Westwood OB-GYN Clinic and Department of Psychiatry.
Screening and Treatment of Anxiety and Depression (STAND)	Online therapy with coaching within STAND	This treatment condition provides access to a system of care, in which type of treatment is allocated based on presenting symptomatology. Participants will learn their allocation from study staff or participants will create a secure account through STAND to learn about their allocation through the STAND online dashboard. Through their STAND online dashboard, they could also have access to their CAT-MH results over time from the start of treatment.
Screening and Treatment of Anxiety and Depression (STAND)	Clinical care within STAND	This treatment condition provides access to a system of care, in which type of treatment is allocated based on presenting symptomatology. Participants will learn their allocation from study staff or participants will create a secure account through STAND to learn about their allocation through the STAND online dashboard. Through their STAND online dashboard, they could also have access to their CAT-MH results over time from the start of treatment.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26	Week 2-26	Evaluation of degree of change in depression score throughout and after defined treatment periods as measured by the CAT-MH scores.; The CAT-MH uses item response theory (IRT) to select a subset of items from a pool of approximately 1000 questions to target the respondent's impairment level. It consists of five modules, which screen for a diagnosis of Major Depressive Disorder, depressive symptoms, anxiety symptoms, mania, and suicidal ideation.

Secondary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS-9)	Post-treatment and week 26	Evaluation of degree of change in depression score after defined treatment periods as measured by the Edinburgh Postnatal Depression Scale (EPDS-9) scores.; The Edinburgh Postnatal Depression Scale (EPDS-9) is a 9-item version of the Edinburgh Postnatal Depression Scale (EPDS-10), which omits the 10th item ("The thought of harming myself has occurred to me") of the original 10-item Edinburgh Postnatal Depression Scale.; The 9 items are summed into a single score ranging from 0 (depression not likely) to 27 (probable depression).

Trial Locations

Locations (1)

University of California, Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States