An interventional study of IntelliCare and COMPASS-Care in Depression, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 75 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Access to the Intellicare suite of digital mental health self-management tools and coaching
Behavioral: IntelliCare
Current care plus access to a website that will provide content specific to perinatal depression
Other: COMPASS-Care
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
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.
Time frame: At 12 weeks
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
Time frame: 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.
Time frame: Week 6, Week 12
TWente Engagement With Ehealth Technologies Scale (TWEETS)
The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS 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.
Time frame: Week 6, Week 12
Execution of Stepped Care
Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 \>=10))
Time frame: Up to 12 weeks
| Milestone | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Started | 38 | 37 |
| Completed | 37 | 37 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| score on a scale | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Depression | 6.42 (4.80 to 8.03) | 6.55 (4.90 to 8.20) |
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
| score on a scale | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Anxiety | 6.57 (5.02 to 8.12) | 7.38 (5.79 to 8.97) |
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.
| score on a scale | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Week 6 | 58 (47 to 68) | 62 (50 to 67) |
| Week 12 | 62 (47 to 68) | 60 (52 to 66) |
The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS 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.
| score on a scale | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Week 6 | 38 (30 to 43) | 26 (22 to 32) |
| Week 12 | 35 (28 to 42) | 27 (24 to 36) |
Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 \>=10))
| Participants | Technology Enabled Service | eTreatment as Usual |
|---|---|---|
| Execution of Stepped Care | 4 | 2 |
Collected over Adverse event data were monitored throughout participant involvement in the clinical trial, up to 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Technology Enabled Service | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| eTreatment as Usual | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Mean | 32.0 (28.8 to 35.5) | 33.2 (29.6 to 36.7) | 32.0 (28.8 to 35.5) |
| Sex: Female, Male(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Female | 38 | 37 | 75 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 11 | 20 |
| Not Hispanic or Latino | 28 | 26 | 54 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 5 | 22 |
| White | 13 | 20 | 33 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 2 | 6 | 8 |
| Region of Enrollment(participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| United States | 38 | 37 | 75 |
| General Health(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Poor | 0 | 1 | 1 |
| Fair | 8 | 6 | 14 |
| Good | 16 | 15 | 31 |
| Very Good | 13 | 14 | 27 |
| Excellent | 1 | 1 | 2 |
| Engaged in Psychotherapy(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Yes | 23 | 31 | 54 |
| No | 15 | 6 | 21 |
| Using Psychiatric Medications(Participants) | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Yes | 13 | 18 | 31 |
| No | 25 | 19 | 44 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Northwestern University