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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone use + treatment as usual | Experimental | Participants will receive treatment as usual and use the smartphone app for the management of mood. |
|
| Treatment as usual | Active Comparator | Participants will receive treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of smartphone application (app) | Behavioral | Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline; 6 weeks post-delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 2 weeks post-delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Judy, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Department of Obstetrics and Gynecology | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28588005 | Result | 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. |
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| Treatment as usual | Other | 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. |
|
| 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. |
| 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. | 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. | Baseline; 4 weeks post-delivery |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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