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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding an emotional wellness component to therapy can improve emotional well-being and increase participation in daily activities for stroke survivors. It compares standard occupational or speech therapy with a version that includes modified Cognitive Behavioral Therapy (mCBT). The trial seeks participants who experienced a stroke at least 30 days ago and are facing emotional issues such as anxiety or sadness related to their stroke. Participants should have a device with internet access to join the tele-rehabilitation sessions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance emotional recovery for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this modified Cognitive Behavioral Therapy is safe for stroke patients?

Research has shown that cognitive behavioral therapy (CBT) can aid stroke survivors by reducing anxiety and enhancing confidence in their balance. For instance, one study found that CBT effectively treated anxiety without major side effects. Another study discovered that a CBT app was easy to use and well-received by stroke survivors, indicating that this treatment is generally well-tolerated.

Overall, evidence suggests that modified Cognitive Behavioral Therapy (mCBT) is safe for stroke survivors. It appears to be a gentle approach, with no serious negative effects reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about modified Cognitive Behavioral Therapy (mCBT) for stroke recovery because it takes a new approach by focusing on both mental and physical rehabilitation. While traditional stroke treatments often focus separately on physical recovery or mental health, mCBT integrates these aspects, potentially offering a more comprehensive recovery process. Additionally, combining mCBT with telerehabilitation, which uses online platforms for therapy, makes the treatment more accessible and convenient for patients who might face mobility challenges. This holistic and accessible approach has the potential to enhance recovery outcomes and improve quality of life for stroke survivors.

What evidence suggests that modified Cognitive Behavioral Therapy might be an effective treatment for stroke?

Studies have shown that modified Cognitive Behavioral Therapy (mCBT) can significantly aid mental recovery for stroke survivors by reducing depression and anxiety and enhancing overall mental health. Research indicates that mCBT can also improve cognitive and memory skills. In this trial, some participants will receive mCBT combined with Telerehabilitation Occupational or Speech Therapy, while others will receive only Telerehabilitation Occupational or Speech Therapy. Another study found that stroke survivors who received mCBT experienced fewer anxiety symptoms and managed daily activities more effectively. Overall, mCBT appears to be an effective method for supporting recovery after a stroke. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisa McTeague, PhD

Principal Investigator

Medical University of South Carolina

Deena Blackett, PhD

Principal Investigator

University of Central Florida

Michelle Woodbury, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11563721/

Effectiveness of a cognitive behavioral therapy program in ... The findings of this study suggest that CBT programs may serve as a valuable intervention, offering psychological support and rehabilitation for stroke patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025195/

Enhancing Neuroplasticity Post Stroke: The Role of ... The RehaCom data analysis revealed notable improvements (p < 0.05) in various cognitive functions for both groups following treatment.

3. medrxiv.org medrxiv.org/content/10.1101/2023.12.15.23300013v1.full.pdf

Cognitive Therapy Approach For Post-Stroke Patients The provision of cognitive-behavioral therapy in this context is anticipated to offer post- stroke patients a more effective path to recovery ...

4. nature.com nature.com/articles/s44220-025-00429-z

A record-linkage study of post-stroke primary care ... On average, stroke survivors experienced moderate reductions in depression and functional impairment and large reductions in anxiety symptoms ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.034218

Rehabilitation of Cognitive Deficits Poststroke: Systematic ... This systematic review and meta-analysis evaluate the effectiveness of rehabilitation interventions across multiple domains of cognitive function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10494803/

Cognitive Rehabilitation Interventions for Post-Stroke ... Cognitive rehabilitation addresses skills in the cognitive domains of attention, memory, and executive functioning and how they impact functionality and safety.

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.022406

Decreasing Fear of Falling in Chronic Stroke Survivors ... Research has shown that balance training is effective for reducing the fear of falling in individuals with a history of stroke.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06689878

Mobile Cognitive Behavioral Therapy for Stroke The primary objective of this study is to assess the feasibility and acceptability of "MAYA", a mobile CBT application, in adults who have had a stroke.

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2549-z

Effectiveness of a combination of cognitive behavioral therapy ... The primary outcome measure is subjective balance confidence. The secondary outcome measures are fear-avoidance behavior, balance ability, fall ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3856474/

Treating anxiety after stroke using cognitive-behaviour ... In two cases, cognitive-behavioural psychotherapy proved effective for anxiety unaccompanied by significant depression, after stroke.