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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

At 12 weeks

Results posted on

2025-09-12

Participant Flow

Participant milestones

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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 12

Population: 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

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 12

Population: 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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

eTreatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Mohr

Northwestern University

Phone: 312-503-1403

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place