Depression, Stroke
Conditions
Brief summary
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.
Interventions
BEHAVIORALCognitive behavioral therapy
An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years of age * Acute ischemic stroke within the past 3 months * Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser. * Subject is willing and able to participate in internet-based cognitive behavioral therapy * Can participate in the program in English * Willingness and ability to sign informed consent by the patient * Symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the Patient Health Questionnaire-9 at the time of study enrollment.
Exclusion criteria
* Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded * Patients with an active bipolar disorder diagnosis are excluded * Patients with personality disorder diagnoses are excluded * Patients with active suicidality or past suicide attempts are excluded * History of schizophrenia or schizoaffective disorder * Active participation in face-to-face psychotherapy prior to stroke * Patients with a history of dementia are excluded * Patients with aphasia, defined as a score of 1 or greater on NIH Stroke Scale Item 9 are excluded. * Patients without regular internet access through a computer, tablet or smartphone are excluded. * Subjects requiring long-term inpatient nursing care are excluded. For patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. Individuals being discharged to a skilled nursing facility or hospice are excluded. * Expected life expectancy less than 6 months or other inability to comply with study follow-up. * Pregnant women and prisoners are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms Over Time | Baseline and 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessed by the EuroQOL-5D | 90 days | EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy (CBT) Program Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy (CBT) Program |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
Time frame: Baseline and 90 days
Population: 1 subject missing day 90 PHQ-9
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) Program | Change in Depressive Symptoms Over Time | 6 scores on scale |
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) Program | Quality of Life Assessed by the EuroQOL-5D | 73 scores on a scale | Standard Deviation 16 |