Internet-based CBT After Stroke Pilot

Stroke Clinical Trial

— iSAD  

Official title:

Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615079
• Other study ID #: 829426
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Stroke

Intervention

Behavioral:
• Cognitive behavioral therapy
An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 90 days
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.	90 days