Internet-based CBT After Stroke Pilot

Last updated: November 10, 2021
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

Depression

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03615079
829426
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theinternet daily, either through a personal smartphone or web-based internet browser.
  • Subject is willing and able to participate in internet-based cognitive behavioraltherapy
  • 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 thePatient Health Questionnaire-9 at the time of study enrollment.

Exclusion

Exclusion Criteria:

  • Severely depressed patients, defined by a score of 20+ on the Patient HealthQuestionnare-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 9are excluded.
  • Patients without regular internet access through a computer, tablet or smartphone areexcluded.
  • Subjects requiring long-term inpatient nursing care are excluded. For patientsenrolled as inpatients, individuals being discharged to both home and acute rehab areeligible. Individuals being discharged to a skilled nursing facility or hospice areexcluded.
  • Expected life expectancy less than 6 months or other inability to comply with studyfollow-up.
  • Pregnant women and prisoners are excluded

Study Design

Total Participants: 28
Study Start date:
June 11, 2018
Estimated Completion Date:
July 30, 2021

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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