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Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) program | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms Over Time | Subject's depressive symptoms will be quantified using the Patient Health Questionnaire 9. This assessment includes 9 close-ended questions with a scoring system ranging from 0 to 27. Scores greater than 10 are considered "positive" for depressive symptoms. We will compare the average PHQ-9 score at study enrollment to the PHQ-9 at 90 days to determine the reduction in depressive symptoms over time. | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessed by the EuroQOL-5D | EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mullen, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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The proportion of subjects who engaged with the CBT application was not what was expected and as such enrollment was expanded with the goal of getting 20 subjects to use the application.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy (CBT) Program | Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who engaged with the CBT application at least once
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy (CBT) Program | Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Depressive Symptoms Over Time | Subject's depressive symptoms will be quantified using the Patient Health Questionnaire 9. This assessment includes 9 close-ended questions with a scoring system ranging from 0 to 27. Scores greater than 10 are considered "positive" for depressive symptoms. We will compare the average PHQ-9 score at study enrollment to the PHQ-9 at 90 days to determine the reduction in depressive symptoms over time. | 1 subject missing day 90 PHQ-9 | Posted | Median | Inter-Quartile Range | scores on scale | Baseline and 90 days |
|
90 days
Definition did not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy (CBT) Program | Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression |
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The aim of this study was to enroll 20 subjects into the computer based cognitive-behavioral therapy intervention. Unfortunately enrollment was slower than expected and the proportion of enrolled subjects who utilized the application was low, limiting the analysis and preventing meaningful conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mullen | University of Pennsylvania | 215-662-3339 | Michael.Mullen@Pennmedicine.Upenn.Edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2018 | Jul 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quality of Life Assessed by the EuroQOL-5D | EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes. | Posted | Mean | Standard Deviation | scores on a scale | 90 days |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |