## Protocol Section
### Identification Module
**NCT ID:** NCT03615079

**Acronym:** iSAD

**Brief Title:** Internet-based CBT After Stroke Pilot

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

#### Organization Study ID Info
**ID:** 829426
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2021-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-11

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-11-10

**Type:** ACTUAL

**Results First Submit Date:** 2021-07-29

**Results First Submit QC Date:** 2021-10-13

#### Start Date
**Date:** 2018-06-11

**Type:** ACTUAL

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2018-08-03
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-18
**Study First Submit QC Date:** 2018-07-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pennsylvania

#### Responsible Party

**Investigator Affiliation:** University of Pennsylvania

**Investigator Full Name:** Michael Mullen

**Investigator Title:** Assistant Professor of Neurology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Stroke

- Depression

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Cognitive behavioral therapy

**Label:** Cognitive Behavioral Therapy (CBT) program

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cognitive Behavioral Therapy (CBT) program

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

**Name:** Cognitive behavioral therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in Depressive Symptoms Over Time

**Time Frame:** Baseline and 90 days

#### Secondary Outcomes

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

**Measure:** Quality of Life Assessed by the EuroQOL-5D

**Time Frame:** 90 days

### Eligibility Module

**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

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** Michael Mullen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-12-13

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1261154

- Type Abbrev: Prot_SAP

- Upload Date: 2021-07-29T10:11

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Definition did not differ

#### Event Groups

**Group ID:** EG000

**Title:** Cognitive Behavioral Therapy (CBT) Program

**Deaths Num At Risk:** 28

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

**ID:** EG000

**Other Num at Risk:** 28

**Serious Number At Risk:** 28

**Title:** Cognitive Behavioral Therapy (CBT) Program

**Frequency Threshold:** 0

**Time Frame:** 90 days

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 11

**Units:** Participants

### Group

**ID:** BG000

**Title:** Cognitive Behavioral Therapy (CBT) Program

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

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.7

**Value:** 55.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 10

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** Subjects who engaged with the CBT application at least once
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** 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.
### Point of Contact
**Email:** Michael.Mullen@Pennmedicine.Upenn.Edu
**Organization:** University of Pennsylvania
**Phone:** 215-662-3339
**Title:** Michael Mullen
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16
- **Upper Limit:** 
- **Value:** 73
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** 1 subject missing day 90 PHQ-9
**Reporting Status:** POSTED
**Time Frame:** Baseline and 90 days
**Title:** Change in Depressive Symptoms Over Time
**Type:** PRIMARY
**Unit of Measure:** scores on scale
##### Group
**Description:** Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
**ID:** OG000
**Title:** Cognitive Behavioral Therapy (CBT) Program
#### Outcome Measure 2
**Description:** EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 90 days
**Title:** Quality of Life Assessed by the EuroQOL-5D
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
**ID:** OG000
**Title:** Cognitive Behavioral Therapy (CBT) Program
### Participant Flow Module
#### Group
**Description:** Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
**ID:** FG000
**Title:** Cognitive Behavioral Therapy (CBT) Program
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Pre-Assignment Details:** The proportion of subjects who engaged with the CBT application was not what was expected and as such enrollment was expanded with the goal of getting 20 subjects to use the application.
**Has Results:** True