Clinical trial NCT05056454: New Moms Mood Tracking & Wellbeing
Official title: Perinatal Mood Tracking and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Perinatal Depression
Anxiety
Pregnancy Related
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26
timeFrame: Week 2-26
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS-9)
timeFrame: Post-treatment and week 26
Other outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Week 26
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
Study officials:
References: