Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03990389
Other study ID # IRB16-1802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2019
Est. completion date February 29, 2020

Study information

Verified date April 2022
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Participants will be randomized to either Usual Care or Usual Care with additional Chatbot Care.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 29, 2020
Est. primary completion date February 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics. - Patient Subject Cohort: 1. Age = 18 years and able to and demonstrate English reading literacy of at least 8th-grade level (REALM-R = 6) 2. Postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (EPDS = 12) 3. Willing to participate and able to give written informed consent 4. Must own a smart phone with a data plan 5. Must have a Facebook account and Facebook Messaging app on phone (or willing to create account/download app today) 6. Sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance Exclusion Criteria: - Provider Subject Cohort: None - Patient Subject Cohort: 1. Subjects with documented dysthymia or Axis II diagnoses 2. Subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation 3. Active suicidality as determined by clinician 4. Non-English speakers

Study Design


Intervention

Device:
Chatbot Intervention
a chatbot will be used to monitor depression severity

Locations

Country Name City State
United States University of Chicago Chicago Illinois
United States NorthShore University HealthSystem Skokie Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Secondary 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
3 months
Secondary Change in Side-effect Burden Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire 3 months
Secondary Change in Maternal Function Measured by the Barkin Index of Maternal Functioning 3 months
Secondary Change in Maternal Confidence Measured by Maternal Confidence Questionnaire 3 months
Secondary Medication Adherence Measured by 1-item medication adherence questionnaire 3 months
See also
  Status Clinical Trial Phase
Completed NCT04012580 - Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression N/A
Recruiting NCT05813782 - The Effect of Baby Massage on Postpartum Depression and Maternal Attachment N/A
Recruiting NCT05907213 - Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery Phase 1
Completed NCT00602732 - Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse Phase 1
Completed NCT00053651 - Prevention of Postpartum Depression in Low-Income Women Phase 1
Completed NCT00043602 - Clinician Managed Interpersonal Psychotherapy Phase 0
Completed NCT04169334 - Look - Your Baby is Talking to You. N/A
Completed NCT03573713 - Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes N/A
Completed NCT04043533 - The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women N/A
Completed NCT06070168 - Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Completed NCT02505984 - Preventing Postpartum Depression With Intranasal Oxytocin Phase 2
Recruiting NCT00251342 - Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale Phase 2/Phase 3
Completed NCT02526433 - The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study) N/A
Completed NCT02526407 - The Impact of Creative Interventions on Symptoms of Postnatal Depression N/A
Completed NCT03574766 - Meditation for NICU Moms N/A
Completed NCT03646539 - RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood N/A
Active, not recruiting NCT05110456 - To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk N/A
Recruiting NCT04154423 - Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study N/A
Not yet recruiting NCT04093791 - MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention N/A