Depression, PostpartumNCT03990389
Tracking Depression Symptoms With a Health Chatbot
A study testing Chatbot Intervention in people with Depression, Postpartum and Depression, Unipolar, run by University of Chicago at 2 sites in United States.
Trial summary
The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators have developed a chatbot which will assist in performing measurement-based care (MBC) via Facebook Messenger. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum, Depression, Unipolar
- What is being tested?
- Chatbot Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2019to 29 Feb 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.
- Patient Subject Cohort:
- Age ≥ 18 years and able to and demonstrate English reading literacy of at least 8th-grade level (REALM-R ≥ 6)
- Postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (EPDS ≥ 12)
- Willing to participate and able to give written informed consent
- Must own a smart phone with a data plan
- Must have a Facebook account and Facebook Messaging app on phone (or willing to create account/download app today)
- Sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance
Who cannot join
- Provider Subject Cohort: None
- Patient Subject Cohort:
- Subjects with documented dysthymia or Axis II diagnoses
- Subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation
- Active suicidality as determined by clinician
- Non-English speakers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
NorthShore University HealthSystem
Skokie, Illinois, 60076
About this study
Official title: Automated Symptom Tracking for Measurement-Based Care of Depression
The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators have developed a chatbot which will assist in performing measurement-based care (MBC) via Facebook Messenger. Participants will be randomized to either Usual Care or Usual Care with additional Chatbot Care.
Read the detailed description
The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators will be looking specifically at depressed women soon after they give birth, otherwise known as known as perinatal depression. Measurement-based care (MBC) which involves the use of quantitative assessments for depression screening, diagnosis, and symptom monitoring is recognized as one of the keys to depression management. MBC can be difficult to implement within the clinical setting due to the administrative overhead and close follow-up required. It is reasonable to hypothesize that low rates of MBC adoption are responsible for low rates of adequate depression care.
The investigators have developed an automated conversational agent or "chatbot" (CB) for delivering MBC via Facebook Messenger. The investigators hypothesize that the use of CB-MBC, which combines a conversational interface with state-of-the-art quantitative assessments, will improve depression symptom severity for patients with perinatal depression. If successful, this project will provide primary care physicians with a new and inexpensive method for delivering better and safer care to their patients with depression. This study works to determine the impact of the chatbot in improving depression outcomes for patients under treatment for perinatal depression.
- Conditions
- Depression, Postpartum, Depression, Unipolar
- Being tested
- Chatbot Intervention
- Medical subject headings
- Depression, Postpartum, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot InterventionDevice
a chatbot will be used to monitor depression severity
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions. Eligible subjects randomized to usual care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning. All participants will be asked to participate in a semi-structured debrief interview upon study completion. |
| Chabot Care Group | Experimental | Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
Eligible subjects randomized to chatbot care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning.
In addition to the above procedures, eligible subjects randomized to chatbot care will receive weekly messages from the chatbot asking them to complete a depression severity measure and side-effect burden assessments. Within week 1 subjects will receive a check-in call from a study coordinator to answer any questions regarding use of the chatbot.
All participants will be asked to participate in a semi-structured debrief interview upon study completion. Receives: Device: Chatbot Intervention |
| Provider Subject Cohort | No intervention | 20 provider subjects from each study site will be enrolled to ensure they understand the study and consent to have their patients enrolled in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Change in Depression Severity
Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score
Measured: 3 months
Secondary outcomes (5)
Change in Depression Severity
Measured by the Computerized Adaptive Test-Depression Inventory (CAT-DI) and calculated change in Edinburgh Postnatal Depression Scale (EPDS) between Baseline and 3 months.
Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score
Measured: 3 months
Change in Side-effect Burden
Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire
Measured: 3 months
Change in Maternal Function
Measured by the Barkin Index of Maternal Functioning
Measured: 3 months
Change in Maternal Confidence
Measured by Maternal Confidence Questionnaire
Measured: 3 months
Medication Adherence
Measured by 1-item medication adherence questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Feb 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
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.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990389
- Sponsor's protocol ID
- IRB16-1802
- Status last verified
- Apr 2022
- First submitted
- 13 Mar 2019
- Last updated
- 12 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Symptom Tracking for Measurement-Based Care of Depression
- ClinicalTrials.gov ID
- NCT03990389
- Acronym / sponsor ID
- IRB16-1802
- Conditions
- Depression, Postpartum, Depression, Unipolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Endeavor Health
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Posted 12 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators have developed a chatbot which will assist in performing measurement-based care (MBC) via Facebook Messenger. Participants will be randomized to either Usual Care or Usual Care with additional Chatbot Care.
Detailed description
The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators will be looking specifically at depressed women soon after they give birth, otherwise known as known as perinatal depression. Measurement-based care (MBC) which involves the use of quantitative assessments for depression screening, diagnosis, and symptom monitoring is recognized as one of the keys to depression management. MBC can be difficult to implement within the clinical setting due to the administrative overhead and close follow-up required. It is reasonable to hypothesize that low rates of MBC adoption are responsible for low rates of adequate depression care.
The investigators have developed an automated conversational agent or "chatbot" (CB) for delivering MBC via Facebook Messenger. The investigators hypothesize that the use of CB-MBC, which combines a conversational interface with state-of-the-art quantitative assessments, will improve depression symptom severity for patients with perinatal depression. If successful, this project will provide primary care physicians with a new and inexpensive method for delivering better and safer care to their patients with depression. This study works to determine the impact of the chatbot in improving depression outcomes for patients under treatment for perinatal depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions. Eligible subjects randomized to usual care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning. All participants will be asked to participate in a semi-structured debrief interview upon study completion. |
| Chabot Care Group | Experimental | Device: Chatbot InterventionSubjects will undergo screening including REALM-R and EPDS and a few additional questions. Eligible subjects randomized to chatbot care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning. In addition to the above procedures, eligible subjects randomized to chatbot care will receive weekly messages from the chatbot asking them to complete a depression severity measure and side-effect burden assessments. Within week 1 subjects will receive a check-in call from a study coordinator to answer any questions regarding use of the chatbot. All participants will be asked to participate in a semi-structured debrief interview upon study completion. |
| Provider Subject Cohort | No intervention | –20 provider subjects from each study site will be enrolled to ensure they understand the study and consent to have their patients enrolled in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.
- Patient Subject Cohort:
Key exclusion criteria (6 listed)
- Provider Subject Cohort: None
- Patient Subject Cohort:
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 |
|---|---|---|
| Chatbot Interventiona chatbot will be used to monitor depression severity | Device | Chabot Care Group |
Primary outcome
Longitudinal Change in Depression Severity
Time frame: 3 months
Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score
5 secondary outcomes
Change in Depression Severity
Time frame: 3 months
Change in Side-effect Burden
Time frame: 3 months
Change in Maternal Function
Time frame: 3 months
Change in Maternal Confidence
Time frame: 3 months
Medication Adherence
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot Intervention in people with Depression, Postpartum and Depression, Unipolar, run by University of Chicago at 2 sites 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 8 inclusion and 6 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 May 2022). 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?
Longitudinal Change in Depression Severity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2022.