New Moms Mood Tracking & Wellbeing
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Treatment as usual (TAU, a.k.a. 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. |
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| Experimental: Screening and Treatment of Anxiety and Depression (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 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
Participants with moderate depressive symptoms on the CAT-MH (and no current suicidality) will be allocated to access a 3-lesson prenatal depression online cognitive-behavioral therapy course (MUMentum) or 6-lesson mixed anxiety and depression cognitive-behavioral therapy course, both from the program offerings of This Way Up. Lesson content is presented in the form of an illustrated story about two fictional characters who are anxious and depressed, but who gain mastery over their problems using CBT techniques. Following each lesson, participants download a document that summarizes the key information in each lesson and which includes practical homework exercises that reinforce the content of the lesson. Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson. Participants will additionally receive up to 9 coaching sessions with a STAND coach, in addition to an initial orientation session.
Behavioral: Clinical care
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.
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Outcome Measures
Primary Outcome Measures
- Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores At Post-Treatment and Week 26 [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.
Secondary Outcome Measures
- Edinburgh Postnatal Depression Scale (EPDS-9) [Post-treatment and week 26]
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).
Other Outcome Measures
- Sheehan Disability Scale (SDS) [Week 26]
The Sheehan Disability Scale (SDS) is a self-report measure which assesses functional impairment in three inter-related domains; work/school, social and family life.The three items asking about work, social life, and family life are rated on a scale of 0-10 where: 0 = Not at all 1-3 = Mildly 4-6 = Moderately 7-9 = Markedly 10 = Extremely The 3 items can also be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women who are between week 28 of their pregnancy and 10 weeks postpartum and are receiving care at a UCLA OB-GYN clinic
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Fluent in English
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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
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Not currently in individual treatment for a behavioral or emotional problem (e.g., anxiety, depression)
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Willingness to follow study procedures
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Willingness to participate in treatment through the study and follow all study procedures, including provide HIPAA Authorization for research
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Has access to the internet via mobile or desktop device
Exclusion Criteria:
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Are currently receiving treatment by a therapist or a psychiatrist
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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)
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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
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Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
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Neurological conditions
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Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
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Cognitive impairment (e.g., developmental disability, dementia)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles (UCLA) | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-001924