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This project will study the effectiveness of computerized cognitive behavioral therapy (CBT) in reducing depression symptoms. The design is a two-arm randomized controlled trial comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is treatment as usual plus computerized CBT. The primary outcome measure is change in depression symptom severity. The name of the computerized CBT program to be used in the study is Thrive.
Population:
Recruitment:
Screening and Enrollment (Enrollment/Assessment Website):
Coaching:
• KP will send each treatment arm participant four emails encouraging them to use Thrive, with the exception that the second email will be replaced by a phone call from KP for patients who have not achieved a minimum level of activity in Thrive at that point.
Endpoint and Follow-up Assessments:
• KP will ask each study participant to visit Enrollment/Assessment Website 2 and 6 months after study enrollment to complete assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | After enrollment in the study, the subject will continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being. | |
| Intervention Arm | Experimental | After enrollment in the study, the subject will be granted 8 weeks of access to "Thrive", an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy. During the first 4 weeks, they will receive 4 coaching emails and/or phone calls encouraging their participation in the study, and answering any program-related questions. The subject will also continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrive | Behavioral | Thrive is an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy principals. |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-9 score change | Change in score on the 9-item Patient Health Questionnaire | 0-6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| GAD-7 score change | Change in score on 7-item Generalized Anxiety Disorder scale | 0-6 months after enrollment |
| Quality of Life change | Change in subjective measure of subject's quality of life (based on Behavioral Risk Factor Surveillance System) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roderick R Stuart, MD | Southern California Permanente Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Fontana Medical Center | Fontana | California | 92335 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Randomized controlled trial. Control arm will receive treatment as usual for depression from primary care physician. Intervention arm will also receive treatment as usual, and access to an internet-based self-help tool for treatment of depression, along with coaching emails and/or phone calls, encouraging their participation and answering questions about how to use the program.
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The primary care physician will not receive feedback about which arm the patient was assigned to.
|
| 0-6 months after enrollment |
| Workplace productivity change | Change in subjective measure of subject's workplace productivity (based on Behavioral Risk Factor Surveillance System) | 0-6 months after enrollment |
| Medication adherence | Measure of compliance with prescribed medications, based on a single item question | 0-6 months after enrollment |
| Psychotherapy utilization | Subjective measurement of whether or not the subject has received psychotherapy from a licensed provider | 12 months prior to enrollment, through 6 months after enrollment |
| Psychiatric specialty utilization | Subjective measurement of whether or not the subject has received treatment from a provider in the Department of Psychiatry | 0-6 months after enrollment |
| Satisfaction with Thrive | Subjective measurement of how satisfied patient was with the treatment intervention | 2 months after enrollment |
| Satisfaction with Kaiser Permanente Southern California | Subjective measurement of how satisfied patient was with their experience of care at Kaiser Permanente Southern California | 0-6 months after enrollment |
| Thrive Adherence | Percent enrolled in Thrive over total number invited, number of logins and lessons started | 0-2 months after enrollment |
| D006573 |
| Heterocyclic Compounds, 1-Ring |