New Moms Mood Tracking & Wellbeing

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Perinatal Depression; Pregnancy Related; Depression; Anxiety

Treatments: Behavioral: Online therapy with coaching within STAND; Behavioral: Clinical care within STAND; Other: Perinatal Psychiatric Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05056454

20-001924

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Perinatal Psychiatric Care

Other group

Description:

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.

Treatment:

Other: Perinatal Psychiatric Care

Screening and Treatment of Anxiety and Depression (STAND)

Experimental group

Description:

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.

Treatment:

Behavioral: Clinical care within STAND

Behavioral: Online therapy with coaching within STAND