New Moms Mood Tracking & Wellbeing

  • STATUS
    Recruiting
  • days left to enroll
    78
  • participants needed
    200
  • sponsor
    University of California, Los Angeles
Updated on 2 October 2021
anxiety
behavior therapy
depressive symptoms
depressed mood
psychotherapy
perinatal depression

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.

Details
Condition Depressed, Endogenous depression, Depression (Major/Severe), Depression (Adolescent), Anxiety Symptoms, Perinatal Asphyxia, Pregnancy Related, anxiety disorder, Generalized Anxiety Disorder (GAD), Anxiety Disorders, depressive disorder, anxious, ANXIETY NEUROSIS, miserable, Anxiety Disorders (Pediatric), Anxiety, depressed mood, depressive disorders, Generalized Anxiety Disorder (GAD - Pediatric), Depression (Treatment-Resistant), Depression (Pediatric), Depression (Adult and Geriatric), Perinatal Depression, Depression
Treatment Clinical Care, Online therapy with coaching
Clinical Study IdentifierNCT05056454
SponsorUniversity of California, Los Angeles
Last Modified on2 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women who are between week 28 of their pregnancy and 10 weeks 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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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