Internet-based CBT After Stroke Pilot (iSAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stroke
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cognitive Behavioral Therapy (CBT) program	Behavioral: Cognitive behavioral therapy; An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Michael Mullen, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 829426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No