Cognitive TherapyNCT03646539
RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood
A study testing Use of smartphone application (app) and Treatment as usual in people with Cognitive Therapy and Depression, Postpartum, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Therapy, Depression, Postpartum, Mental Health
- What is being tested?
- Use of smartphone application (app) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 4 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postpartum day 0-7 after delivery
- Medically stable and cleared for discharge
- Owns smartphone
- English-speaking (because all intervention materials are in English)
Who cannot join
- Neonatal demise this admission
- Intrauterine fetal demise this admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Department of Obstetrics and Gynecology
Stanford, California, 94305
About this study
Official title: Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.
Read the detailed description
The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).
- Conditions
- Cognitive Therapy, Depression, Postpartum, Mental Health, Depression, Depressive Disorder, Anxiety
- Being tested
- Use of smartphone application (app), Treatment as usual
- Keywords
- Automated conversational agent
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being, Depression, Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of smartphone application (app)Behavioural
Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.
Treatment as usualOther
Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone use + treatment as usual | Experimental | Participants will receive treatment as usual and use the smartphone app for the management of mood. Receives: Behavioral: Use of smartphone application (app); Other: Treatment as usual |
| Treatment as usual | Active comparator | Participants will receive treatment as usual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Baseline; 6 weeks post-delivery
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
Measured: Baseline; 6 weeks post-delivery
Secondary outcomes (4)
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Baseline; 2 weeks post-delivery
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Baseline; 4 weeks post-delivery
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
Measured: Baseline; 2 weeks post-delivery
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
Measured: Baseline; 4 weeks post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Oct 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive TherapyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Judy, Stanford University
- Investigators
- Amy Judy, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646539
- Sponsor's protocol ID
- IRB-46467
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2018
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.
PubMed 28588005
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
- ClinicalTrials.gov ID
- NCT03646539
- Acronym / sponsor ID
- IRB-46467
- Conditions
- Cognitive Therapy, Depression, Postpartum, Mental Health, Depression, Depressive Disorder, Anxiety
- Keywords
- Automated conversational agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.
Detailed description
The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone use + treatment as usual | Experimental | Behavioral: Use of smartphone application (app), Other: Treatment as usualParticipants will receive treatment as usual and use the smartphone app for the management of mood. |
| Treatment as usual | Active comparator | Other: Treatment as usualParticipants will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum day 0-7 after delivery
- Medically stable and cleared for discharge
- Owns smartphone
- English-speaking (because all intervention materials are in English)
Key exclusion criteria (2 listed)
- Neonatal demise this admission
- Intrauterine fetal demise this admission
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 |
|---|---|---|
| Use of smartphone application (app)Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood. | Behavioural | Smartphone use + treatment as usual |
| Treatment as usualTreatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms. | Other | Smartphone use + treatment as usual, Treatment as usual |
Primary outcome
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
Time frame: Baseline; 6 weeks post-delivery
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks
Time frame: Baseline; 6 weeks post-delivery
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
4 secondary outcomes
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery
Time frame: Baseline; 2 weeks post-delivery
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery
Time frame: Baseline; 4 weeks post-delivery
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks
Time frame: Baseline; 2 weeks post-delivery
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks
Time frame: Baseline; 4 weeks post-delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Results publication: PubMed 28588005Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.
- 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.
Amy Judy, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of smartphone application (app) and Treatment as usual in people with Cognitive Therapy and Depression, Postpartum, run by Stanford University at 1 site 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 4 inclusion and 2 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery (time frame: Baseline; 6 weeks post-delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646539, which also lists 1 linked publication.
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 21 Sep 2020.