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New Moms Mood Tracking & Wellbeing

Primary Purpose

Depression, Perinatal Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online therapy with coaching
Clinical care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California, Los Angeles (UCLA)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual (TAU, a.k.a. Perinatal Psychiatric Care)

Screening and Treatment of Anxiety and Depression (STAND)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 12, 2021
Last Updated
June 21, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05056454
Brief Title
New Moms Mood Tracking & Wellbeing
Official Title
Perinatal Mood Tracking and Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Perinatal Depression, Anxiety, Pregnancy Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU, a.k.a. Perinatal Psychiatric Care)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Screening and Treatment of Anxiety and Depression (STAND)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online therapy with coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores At Post-Treatment and Week 26
Description
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.
Time Frame
Post-treatment and week 26
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS-9)
Description
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).
Time Frame
Post-treatment and week 26
Other Pre-specified Outcome Measures:
Title
Sheehan Disability Scale (SDS)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa McDonald, MS
Phone
(310) 872-4010
Email
itn@mednet.ucla.edu
Facility Information:
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa McDonald, MS
Phone
310-872-4010
Email
itn@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Michelle G Craske, PhD
First Name & Middle Initial & Last Name & Degree
Nelson Freimer, MD
First Name & Middle Initial & Last Name & Degree
Misty Richards, MD

12. IPD Sharing Statement

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New Moms Mood Tracking & Wellbeing

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