Depression
Conditions
Keywords
Perinatal
Brief 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.
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.
Interventions
BEHAVIORALIntelliCare
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
OTHERCOMPASS-Care
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
Sponsors
Brown University
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | At 12 weeks | 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 |
| Satisfaction Index - Mental Health | Week 6, Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | Week 6, Week 12 | 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. |
| Execution of Stepped Care | Up to 12 weeks | 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)) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 37 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Technology Enabled Service | eTreatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 32.0 years | 33.2 years | 32.0 years |
| Education Associate degree | 1 Participants | 1 Participants | 2 Participants |
| Education Bachelor's Degree | 9 Participants | 7 Participants | 16 Participants |
| Education High School Graduate/ GED | 8 Participants | 4 Participants | 12 Participants |
| Education Post-bachelor's Education | 8 Participants | 14 Participants | 22 Participants |
| Education Some college | 11 Participants | 11 Participants | 22 Participants |
| Education Some high school or less | 1 Participants | 0 Participants | 1 Participants |
| Employed No | 12 Participants | 9 Participants | 21 Participants |
| Employed Prefer not to answer | 2 Participants | 0 Participants | 2 Participants |
| Employed Yes | 24 Participants | 28 Participants | 52 Participants |
| Engaged in Psychotherapy No | 15 Participants | 6 Participants | 21 Participants |
| Engaged in Psychotherapy Yes | 23 Participants | 31 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 11 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 26 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| General Health Excellent | 1 Participants | 1 Participants | 2 Participants |
| General Health Fair | 8 Participants | 6 Participants | 14 Participants |
| General Health Good | 16 Participants | 15 Participants | 31 Participants |
| General Health Poor | 0 Participants | 1 Participants | 1 Participants |
| General Health Very Good | 13 Participants | 14 Participants | 27 Participants |
| Household Size 1 | 2 Participants | 0 Participants | 2 Participants |
| Household Size 2 | 10 Participants | 10 Participants | 20 Participants |
| Household Size 3 | 10 Participants | 18 Participants | 28 Participants |
| Household Size 4+ | 16 Participants | 9 Participants | 25 Participants |
| Income $100,000 + | 12 Participants | 19 Participants | 31 Participants |
| Income $10,000 - $19,999 | 3 Participants | 3 Participants | 6 Participants |
| Income $20,000 - $39,999 | 4 Participants | 4 Participants | 8 Participants |
| Income $40,000 - $59,999 | 5 Participants | 3 Participants | 8 Participants |
| Income $60,000 - $99,999 | 4 Participants | 4 Participants | 8 Participants |
| Income Don't know | 1 Participants | 1 Participants | 2 Participants |
| Income Less than $10,000 | 9 Participants | 0 Participants | 9 Participants |
| Income Prefer not to answer | 0 Participants | 3 Participants | 3 Participants |
| Marital Status Divorced | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Domestic partnership | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Living with partner | 6 Participants | 6 Participants | 12 Participants |
| Marital Status Married | 17 Participants | 25 Participants | 42 Participants |
| Marital Status Separated | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Single; never married | 12 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 5 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) White | 13 Participants | 20 Participants | 33 Participants |
| Region of Enrollment United States | 38 participants | 37 participants | 75 participants |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Using Psychiatric Medications No | 25 Participants | 19 Participants | 44 Participants |
| Using Psychiatric Medications Yes | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 37 |
| other Total, other adverse events | 0 / 38 | 0 / 37 |
| serious Total, serious adverse events | 0 / 38 | 0 / 37 |
Outcome results
Primary
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
Population: Analysis from all observed data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Technology Enabled Service | Depression | 6.42 score on a scale |
| eTreatment as Usual | Depression | 6.55 score on a scale |
Secondary
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
Population: From all observed data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Technology Enabled Service | Anxiety | 6.57 score on a scale |
| eTreatment as Usual | Anxiety | 7.38 score on a scale |
Secondary
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
Population: From all observed data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Technology Enabled Service | Satisfaction Index - Mental Health | Week 6 | 58 score on a scale |
| Technology Enabled Service | Satisfaction Index - Mental Health | Week 12 | 62 score on a scale |
| eTreatment as Usual | Satisfaction Index - Mental Health | Week 12 | 60 score on a scale |
| eTreatment as Usual | Satisfaction Index - Mental Health | Week 6 | 62 score on a scale |
Other Pre-specified
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
Population: Analysis only completed on patients meeting criteria for stepped care, as described.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Technology Enabled Service | Execution of Stepped Care | 4 Participants |
| eTreatment as Usual | Execution of Stepped Care | 2 Participants |
Other Pre-specified
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
Population: from all observed data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Technology Enabled Service | TWente Engagement With Ehealth Technologies Scale (TWEETS) | Week 6 | 38 score on a scale |
| Technology Enabled Service | TWente Engagement With Ehealth Technologies Scale (TWEETS) | Week 12 | 35 score on a scale |
| eTreatment as Usual | TWente Engagement With Ehealth Technologies Scale (TWEETS) | Week 6 | 26 score on a scale |
| eTreatment as Usual | TWente Engagement With Ehealth Technologies Scale (TWEETS) | Week 12 | 27 score on a scale |