Trial Outcomes & Findings for Evaluating Technology Enabled Services in Perinatal Depression (NCT NCT05525689)
NCT ID: NCT05525689
Last Updated: 2025-09-12
Results Overview
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.
COMPLETED
NA
75 participants
At 12 weeks
2025-09-12
Participant Flow
Participant milestones
| Measure |
Technology Enabled Service
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Technology Enabled Service
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluating Technology Enabled Services in Perinatal Depression
Baseline characteristics by cohort
| Measure |
Technology Enabled Service
n=38 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=37 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
n=99 Participants
|
33.2 years
n=107 Participants
|
32.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
37 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
General Health
Poor
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
General Health
Fair
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
General Health
Good
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
General Health
Very Good
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
General Health
Excellent
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Engaged in Psychotherapy
Yes
|
23 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Engaged in Psychotherapy
No
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Using Psychiatric Medications
Yes
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Using Psychiatric Medications
No
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Education
Some high school or less
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Education
High School Graduate/ GED
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Education
Associate degree
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education
Some college
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Education
Bachelor's Degree
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Education
Post-bachelor's Education
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Employed
Yes
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Employed
No
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Employed
Prefer not to answer
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Income
Less than $10,000
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Income
$10,000 - $19,999
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Income
$20,000 - $39,999
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Income
$40,000 - $59,999
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Income
$60,000 - $99,999
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Income
$100,000 +
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Income
Don't know
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Income
Prefer not to answer
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Marital Status
Domestic partnership
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Marital Status
Living with partner
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Marital Status
Married
|
17 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Marital Status
Separated
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Marital Status
Single; never married
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Household Size
1
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Household Size
2
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Household Size
3
|
10 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Household Size
4+
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Analysis from all observed data
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.
Outcome measures
| Measure |
Technology Enabled Service
n=38 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=37 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Depression
|
6.42 score on a scale
Interval 4.8 to 8.03
|
6.55 score on a scale
Interval 4.9 to 8.2
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: From all observed data
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
Outcome measures
| Measure |
Technology Enabled Service
n=38 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=37 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Anxiety
|
6.57 score on a scale
Interval 5.02 to 8.12
|
7.38 score on a scale
Interval 5.79 to 8.97
|
SECONDARY outcome
Timeframe: Week 6, Week 12Population: From all observed data
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.
Outcome measures
| Measure |
Technology Enabled Service
n=38 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=37 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Satisfaction Index - Mental Health
Week 6
|
58 score on a scale
Interval 47.0 to 68.0
|
62 score on a scale
Interval 50.0 to 67.0
|
|
Satisfaction Index - Mental Health
Week 12
|
62 score on a scale
Interval 47.0 to 68.0
|
60 score on a scale
Interval 52.0 to 66.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6, Week 12Population: from all observed data
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.
Outcome measures
| Measure |
Technology Enabled Service
n=38 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=37 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
TWente Engagement With Ehealth Technologies Scale (TWEETS)
Week 6
|
38 score on a scale
Interval 30.0 to 43.0
|
26 score on a scale
Interval 22.0 to 32.0
|
|
TWente Engagement With Ehealth Technologies Scale (TWEETS)
Week 12
|
35 score on a scale
Interval 28.0 to 42.0
|
27 score on a scale
Interval 24.0 to 36.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksPopulation: Analysis only completed on patients meeting criteria for stepped care, as described.
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))
Outcome measures
| Measure |
Technology Enabled Service
n=19 Participants
Access to the Intellicare suite of digital mental health self-management tools and coaching
IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
eTreatment as Usual
n=10 Participants
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|---|---|---|
|
Execution of Stepped Care
|
4 Participants
|
2 Participants
|
Adverse Events
Technology Enabled Service
eTreatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place