New Moms Mood Tracking & Wellbeing

Study Overview
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Brief Summary
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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 can participate in treatment. Women 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. In STAND, participants will be further 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.

Official Title
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Perinatal Mood Tracking and Treatment

Conditions
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Depression, Perinatal Depression, Anxiety, Pregnancy Related

Intervention / Treatment
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* Behavioral: Online therapy with coaching
* Behavioral: Clinical care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual (TAU, a.k.a. Perinatal Psychiatric Care)<br>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. | |
| Experimental: Screening and Treatment of Anxiety and Depression (STAND)<br>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 a) their CAT-MH results over time from the start of treatment, b) assessment of their current diet/nutrition and psychoeducation about the relationship between diet/nutrition and mental health, and c) list of additional resources available to them. | Behavioral: Online therapy with coaching<br>* Participants with moderate depressive symptoms on the CAT-MH (and no current suicidality) will meet with a trained coach, and receive access to online course materials from one of 2 lesson platforms - ThisWayUp's MUMentum course or Rainfrog's ParentMood course. Lesson content is presented as illustrated stories about characters who are anxious and depressed then gain mastery over their problems using CBT techniques. The efficacy of each online course will be compared for equivalency. Following each lesson, participants are provided a document that summarizes key lesson information and practical homework exercises that reinforce the content of the lesson. Participants are encouraged to practice their lesson homework for at least one week before meeting with their coach and starting the next lesson.<br>Behavioral: Clinical care<br>* Participants with severe depressive symptoms or significant suicidality on the CAT-MH will be allocated to access clinical care, which entails weekly psychotherapy sessions and psychiatric care, when needed or appropriate. While clinical care will be available for the entire 6-month duration of the treatment component of the study, participants will be informed that on average therapy is completed within 13 sessions. The schedule of psychiatric care will be determined by the provider and will be comparable to that provided in the TAU arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores At Post-Treatment and Week 26 | Evaluation of degree of reduction in depression score 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. | Post-treatment and week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale (EPDS-9) | Evaluation of degree of reduction 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). | Post-treatment and week 26 |