Modified Cognitive Behavioral Therapy for Stroke

(eWELL Trial)

Overseen By Kelly Rishe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Cognitive impairment, Pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

Research Team

Deena Blackett, PhD

Principal Investigator

University of Central Florida

Michelle Woodbury, PhD

Principal Investigator

Medical University of South Carolina

Lisa McTeague, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults over 21 who have had a stroke at least 30 days ago and are experiencing emotional challenges like anxiety or sadness. Participants must speak English, be able to use their own device with internet for tele-rehabilitation, and have the cognitive and physical ability to engage in therapy sessions as judged by a therapist.

Inclusion Criteria

I experience emotional issues like anxiety or sadness due to stroke.

I had a stroke over 30 days ago and have difficulty speaking or using my arm.

I can join the study's online programs using my own device and internet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 9 telerehabilitation therapy sessions over 8 weeks, focusing on occupational therapy and/or speech therapy with an emotional wellness component for one group

8 weeks

9 visits (virtual)

Assessment

Participants complete 2 assessment visits, one before and one after the telerehabilitation program, to evaluate emotional well-being, quality of life, and other measures

1 week

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• modified Cognitive Behavioral Therapy (mCBT)

Trial Overview The study tests if adding modified Cognitive Behavioral Therapy (mCBT) to occupational or speech therapy via tele-rehabilitation can improve emotional well-being and activity participation in people recovering from a stroke.

Participant Groups

Group I: modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy Experimental Treatment 2 Interventions

Group II: Telerehabilitation Occupational or Speech Therapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+