New Moms Mood Tracking & Wellbeing

Depression Clinical Trial

Official title:

Perinatal Mood Tracking and Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056454
• Other study ID #: 20-001924
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: University of California, Los Angeles
• Contact: Vanessa McDonald, MS
• Phone: (310) 872-4010
• Email: itn[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Perinatal Depression
• Pregnancy Related

Intervention

Behavioral:
• Online therapy with coaching
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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles (UCLA)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Week 26
Primary	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	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