Trial Outcomes & Findings for Internet-based CBT After Stroke Pilot (NCT NCT03615079)

Last Updated: 2021-11-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Baseline and 90 days

Results posted on

2021-11-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy (CBT) Program Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Overall Study STARTED	28
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Internet-based CBT After Stroke Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy (CBT) Program n=11 Participants Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Age, Continuous	55.3 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 90 days

Population: 1 subject missing day 90 PHQ-9

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy (CBT) Program n=10 Participants Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Change in Depressive Symptoms Over Time	6 scores on scale Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy (CBT) Program n=11 Participants Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Quality of Life Assessed by the EuroQOL-5D	73 scores on a scale Standard Deviation 16

Adverse Events

Cognitive Behavioral Therapy (CBT) Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Mullen

University of Pennsylvania

Phone: 215-662-3339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place