An interventional study of Online therapy with coaching within STAND and Clinical care within STAND in Depression, Perinatal Depression and Anxiety, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 166 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.
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Exclusion Criteria:
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.
Other: Perinatal Psychiatric Care
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.
Behavioral: Online therapy with coaching within STAND · Behavioral: Clinical care within STAND
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 UCLA DGC's ParentMood course. The efficacy of each online course will be compared for equivalency. Participants are encouraged to practice their lesson homework for at least one week before meeting with their coach and starting the next lesson.
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.
Perinatal psychiatric care involves medication management and supportive therapy for up to six months, with referrals to relevant community resources by the final visit.
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 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.
Time frame: Week 2-26
Edinburgh Postnatal Depression Scale (EPDS-9)
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).
Time frame: Post-treatment and week 26
Sheehan Disability Scale (SDS)
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).
Time frame: Week 26
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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