Internet-based CBT After Stroke Pilot

NCT ID: NCT03615079

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2021-07-30

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.

Conditions

Stroke; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy (CBT) program

Group Type: OTHER

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive behavioral therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Michael Mullen

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Mullen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

829426

Identifier Type: -

Identifier Source: org_study_id