Clinical trial NCT03615079: Internet-based CBT After Stroke Pilot
Official title: Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Depressive Symptoms Over Time
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Quality of Life Assessed by the EuroQOL-5D
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Mullen, MD
role: PRINCIPAL_INVESTIGATOR
References: