Internet-based CBT After Stroke Pilot

NCT03615079 | Completed Results

• 1 other identifier: 829426
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life Assessed by the EuroQOL-5D

  90 days

Study Arms (1)

Cognitive Behavioral Therapy (CBT) program

OTHER

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

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

Cognitive Behavioral Therapy (CBT) program

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stroke; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The aim of this study was to enroll 20 subjects into the computer based cognitive-behavioral therapy intervention. Unfortunately enrollment was slower than expected and the proportion of enrolled subjects who utilized the application was low, limiting the analysis and preventing meaningful conclusions.

Results Point of Contact

• Title: Michael Mullen
• Organization: University of Pennsylvania

Michael.Mullen@Pennmedicine.Upenn.Edu

215-662-3339

Study Officials

• Michael Mullen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 3, 2018
• Study Start: June 11, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 11, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)