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Internet-based CBT After Stroke Pilot (iSAD)

Primary Purpose

Stroke, Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive behavioral therapy

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitive Behavioral Therapy (CBT) program

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03615079

First Posted

June 18, 2018

Last Updated

November 10, 2021

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03615079

Brief Title

Internet-based CBT After Stroke Pilot

Acronym

iSAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 11, 2018 (Actual)

Primary Completion Date

July 30, 2021 (Actual)

Study Completion Date

July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Depression

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy (CBT) program

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Depressive Symptoms Over Time

Description

Time Frame

Baseline and 90 days

Secondary Outcome Measure Information:

Title

Quality of Life Assessed by the EuroQOL-5D

Description

EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Mullen, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Internet-based CBT After Stroke Pilot

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