DepressionNCT05525689
Evaluating Technology Enabled Services in Perinatal Depression
A study testing IntelliCare and COMPASS-Care in people with Depression, run by Northwestern University at 1 site in United States.
Trial summary
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- IntelliCare and COMPASS-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- 18 years or older
- Referred to Northwestern Medicine COMPASS program for mental health care
- Currently pregnant or within 3 months of delivery
- Moderate to severe perinatal depression (defined as a PHQ-9 screen greater than or equal to 10)
- Owns a smartphone, has used smartphone in last 7 days
Who cannot join
- Experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index pregnancy)
- Severe suicidality (as defined by the presence of a plan and intent to act on that plan)
- Not meeting the inclusion criteria described above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.
Read the detailed description
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.
- Conditions
- Depression
- Being tested
- IntelliCare, COMPASS-Care
- Keywords
- Perinatal
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCareBehavioural
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
COMPASS-CareOther
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
| Study group | Role | What they receive |
|---|---|---|
| Technology Enabled Service | Experimental | Access to the Intellicare suite of digital mental health self-management tools and coaching Receives: Behavioral: IntelliCare |
| eTreatment as Usual | Active comparator | Current care plus access to a website that will provide content specific to perinatal depression Receives: Other: COMPASS-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Assessed by Patient Health Questionnaire-9
Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: At 12 weeks
Secondary outcomes (2)
Anxiety
Assessed by General Anxiety Disorder - 7
Scores range from 0-21. The following cut-offs correlate with level of anxiety severity:
Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Measured: At 12 weeks
Satisfaction Index - Mental Health
The Satisfaction Index - Mental Health measures satisfaction with mental health treatment. The measure includes 12 items, each rated on a 1-6 point likert scale (range of 6-72 points for total score) where higher scores reflect higher satisfaction.
Scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups.
Measured: Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start16 Jun 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Northwestern UniversityThe 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David Mohr, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525689
- Sponsor's protocol ID
- MH119029-RP2-RCT
- Other IDs
- 5P50MH119029-04
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2022
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller ES, Mohr DC, Williams D, Shikany M, Walsh T, Winquist NW, Mir Z, Gray EL, Smith SR, Krause C, Baez LM, Reddy MC. A technology-enabled service for perinatal collaborative care models: A randomized clinical trial. Pregnancy (Hoboken). 2026 May 4;2(3):e70298. doi: 10.1002/pmf2.70298. eCollection 2026 May.
PubMed 42597011
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
- ClinicalTrials.gov ID
- NCT05525689
- Acronym / sponsor ID
- MH119029-RP2-RCT
- Conditions
- Depression
- Keywords
- Perinatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Brown University, National Institute of Mental Health (NIMH)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.
Detailed description
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology Enabled Service | Experimental | Behavioral: IntelliCareAccess to the Intellicare suite of digital mental health self-management tools and coaching |
| eTreatment as Usual | Active comparator | Other: COMPASS-CareCurrent care plus access to a website that will provide content specific to perinatal depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking
- 18 years or older
- Referred to Northwestern Medicine COMPASS program for mental health care
- Currently pregnant or within 3 months of delivery
- Moderate to severe perinatal depression (defined as a PHQ-9 screen greater than or equal to 10)
Key exclusion criteria (3 listed)
- Experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index pregnancy)
- Severe suicidality (as defined by the presence of a plan and intent to act on that plan)
- Not meeting the inclusion criteria described above
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 |
|---|---|---|
| IntelliCareApplication with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization | Behavioural | Technology Enabled Service |
| COMPASS-CareWebsite with content specific to perinatal depression and standard EHR-based tools for patient communication | Other | eTreatment as Usual |
Primary outcome
Depression
Time frame: At 12 weeks
Assessed by Patient Health Questionnaire-9 Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
2 secondary outcomes
Anxiety
Time frame: At 12 weeks
Satisfaction Index - Mental Health
Time frame: Week 6, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42597011Miller ES, Mohr DC, Williams D, Shikany M, Walsh T, Winquist NW, Mir Z, Gray EL, Smith SR, Krause C, Baez LM, Reddy MC. A technology-enabled service for perinatal collaborative care models: A randomized clinical trial. Pregnancy (Hoboken). 2026 May 4;2(3):e70298. doi: 10.1002/pmf2.70298. eCollection 2026 May.
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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.
David Mohr principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare and COMPASS-Care in people with Depression, run by Northwestern University 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 6 inclusion and 3 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 12 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression (time frame: At 12 weeks). 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 NCT05525689, 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 12 Sep 2025.