Internet-based CBT After Stroke Pilot (iSAD)
Primary Purpose
Stroke, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cognitive Behavioral Therapy (CBT) program
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03615079
First Posted
June 18, 2018
Last Updated
November 10, 2021
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03615079
Brief Title
Internet-based CBT After Stroke Pilot
Acronym
iSAD
Official Title
Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy (CBT) program
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms Over Time
Description
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
Secondary Outcome Measure Information:
Title
Quality of Life Assessed by the EuroQOL-5D
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mullen, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Internet-based CBT After Stroke Pilot
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