DepressionNCT05056454
New Moms Mood Tracking & Wellbeing
A study testing Online therapy with coaching within STAND, Clinical care within STAND and Perinatal Psychiatric Care in people with Depression and Perinatal Depression, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression, Perinatal Depression, Anxiety
- What is being tested?
- Online therapy with coaching within STAND, Clinical care within STAND and Perinatal Psychiatric Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Official title: Perinatal Mood Tracking 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.
- Conditions
- Depression, Perinatal Depression, Anxiety, Pregnancy Related
- Being tested
- Online therapy with coaching within STAND, Clinical care within STAND, Perinatal Psychiatric Care
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online therapy with coaching within STANDBehavioural
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.
Clinical care within STANDBehavioural
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 CareOther
Perinatal psychiatric care involves medication management and supportive therapy for up to six months, with referrals to relevant community resources by the final visit.
| Study group | Role | What they receive |
|---|---|---|
| Perinatal Psychiatric Care | Other | 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. Receives: Other: Perinatal Psychiatric Care |
| Screening and Treatment of Anxiety and Depression (STAND) | Experimental | 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. Receives: Behavioral: Online therapy with coaching within STAND; Behavioral: Clinical care within STAND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2-26
Secondary outcomes (1)
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).
Measured: Post-treatment and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start15 Apr 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056454
- Sponsor's protocol ID
- 20-001924
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wolitzky-Taylor K, Richards MC, Welborn A, McDonald V, Arnaudova I, Fears S, O'Mahen H, Newby JM, Millard M, Metts AV, Stein A, Freimer N, Craske MG. Study protocol: perinatal mood treatment study. Trials. 2024 Aug 6;25(1):525. doi: 10.1186/s13063-024-08086-w.
PubMed 39107820
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Mood Tracking and Treatment
- ClinicalTrials.gov ID
- NCT05056454
- Acronym / sponsor ID
- 20-001924
- Conditions
- Depression, Perinatal Depression, Anxiety, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal Psychiatric Care | Other | Other: Perinatal Psychiatric CareThis 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. |
| Screening and Treatment of Anxiety and Depression (STAND) | Experimental | Behavioral: Online therapy with coaching within STAND, Behavioral: Clinical care within STANDThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online therapy with coaching within STANDParticipants 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. | Behavioural | Screening and Treatment of Anxiety and Depression (STAND) |
| Clinical care within STANDParticipants 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. | Behavioural | Screening and Treatment of Anxiety and Depression (STAND) |
| Perinatal Psychiatric CarePerinatal psychiatric care involves medication management and supportive therapy for up to six months, with referrals to relevant community resources by the final visit. | Other | Perinatal Psychiatric Care |
Primary outcome
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26
Time frame: Week 2-26
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.
1 secondary outcome
Edinburgh Postnatal Depression Scale (EPDS-9)
Time frame: Post-treatment and week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 39107820Wolitzky-Taylor K, Richards MC, Welborn A, McDonald V, Arnaudova I, Fears S, O'Mahen H, Newby JM, Millard M, Metts AV, Stein A, Freimer N, Craske MG. Study protocol: perinatal mood treatment study. Trials. 2024 Aug 6;25(1):525. doi: 10.1186/s13063-024-08086-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online therapy with coaching within STAND, Clinical care within STAND and Perinatal Psychiatric Care in people with Depression and Perinatal Depression, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26 (time frame: Week 2-26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.