Mobile Cognitive Behavioral Therapy for Stroke

Overseen By Abhishek Jaywant, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Aphasia, Non-fluency in English, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called "MAYA" to evaluate its effectiveness in helping stroke survivors with anxiety or depression. The app provides lessons and activities designed to help users manage emotions, engage in meaningful activities, and learn relaxation skills. Participants will use the app for 30 minutes a day, twice a week, over eight weeks. It suits adults who had a stroke at least a month ago, experience anxiety or depression, can independently use an iPhone or iPad, and have internet access at home. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emotional well-being for stroke survivors.

Will I have to stop taking my current medications?

If you are taking medication for depression or anxiety, you need to be on a stable dose for at least 8 weeks before starting the study. The trial does not specify if you need to stop other medications.

What prior data suggests that this mobile cognitive behavioral therapy app is safe for stroke patients?

Research shows that mobile health apps, like the one under study, can help manage anxiety and depression after a stroke. Researchers are examining these apps for their potential to support recovery and improve mental health.

Although specific results from this study are not yet available, similar apps for cognitive behavioral therapy have been tested in other contexts. These studies have found that such apps are generally well-received, with few serious side effects reported. Since this study focuses on testing the app's usability and acceptability, it suggests that the app is expected to be safe for users.

This study is in the early stages, concentrating on how people use and accept the app. While detailed safety data is not yet available, past research considers mobile apps for therapy promising and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stroke recovery focus on physical rehabilitation and medication to address symptoms like muscle weakness and blood clots. However, the Mobile Cognitive Behavioral Therapy (CBT) app is unique because it targets the mental health aspects of recovery, such as anxiety and depression, which are often overlooked. Researchers are excited about this treatment because it offers a convenient, app-based delivery method, allowing stroke survivors to engage in therapy from home. The app provides interactive modules and tools for monitoring emotional well-being, promoting mindfulness, and enhancing problem-solving skills, making it a holistic approach to stroke recovery.

What evidence suggests that this mobile cognitive behavioral therapy app is effective for anxiety and mood disorders in stroke patients?

Research has shown that mobile health technology, such as apps, can help manage depression after a stroke and improve control of risk factors. In this trial, all participants will use a mobile cognitive behavioral therapy (CBT) app, which may aid stroke recovery. These apps offer strategies to manage emotions, reduce anxiety, and encourage engagement in meaningful activities. Studies suggest that these apps provide accessible mental health support for stroke survivors. However, researchers are still studying their full clinical effectiveness. Overall, mobile CBT apps appear promising for enhancing mental health in stroke survivors. ^{1 2 3 4 6}

Who Is on the Research Team?

Abhishek Jaywant, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Adults aged 40-79 who've had a stroke at least one month ago, can use an iPhone or iPad, have home internet access, and are experiencing anxiety or depression. They must be able to consent and participate for the full study duration. Those on stable medication for these conditions can join but not if they have severe cognitive difficulties, moderate/severe aphasia, bipolar/psychotic disorders, substance abuse issues, non-fluency in English or active suicidal thoughts.

Inclusion Criteria

No greater than mild cognitive difficulties based on an eligibility evaluation conducted as part of the study

I am able to understand and agree to the study's procedures and risks.

Presence of clinically-significant anxiety and/or depression (as determined by an eligibility evaluation)

Exclusion Criteria

Any other clinical or medical reason in the study doctor's initial screening evaluation that suggests the study is not appropriate for the participant

Aphasia of moderate or greater severity (as determined during an eligibility evaluation)

History of a bipolar or psychotic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the mobile CBT app 'MAYA' for 30 minutes per day, 2 days per week, for 8 weeks. Weekly check-ins are conducted in person or via Zoom to assess intervention adherence and mood symptoms.

8 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Cognitive Behavioral App

Trial Overview The trial is testing 'MAYA', a mobile app designed to deliver cognitive behavioral therapy (CBT) for adults recovering from a stroke who are dealing with anxiety and depression. The study will evaluate how practical and acceptable this digital intervention is.

How Is the Trial Designed?

Group I: Intervention Arm Using the Mobile Cognitive Behavioral Therapy App Experimental Treatment 1 Intervention

All participants will receive the same intervention arm, a mobile cognitive behavioral therapy (CBT) app that includes modules with educational content and teaching and practice of strategies that address the following: education about anxiety and depression and their association with stroke recovery; awareness and monitoring of emotions; behavioral activation, i.e., increasing engagement in valued and meaningful activities; increasing awareness of thinking errors and reframing negative thoughts; mindfulness; relaxation skills; increasing tolerance of anxiety in anxiety-provoking situations; and problem-solving. The application includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. Participants will be asked to use the application for 30 minutes per day, 2 days per week, for 8 weeks.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Mobile tablet-based therapies (MTBTs) show promise in improving access to rehabilitation for stroke survivors, with positive patient responses reported in both inpatient and home settings.

Common barriers to effective use of MTBTs include complex therapy instructions and unreliable internet connections, suggesting that some level of support from therapists or caregivers may be necessary to enhance patient adherence and overcome these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile tablet-based therapies following stroke: A systematic scoping review of administrative methods and patient experiences. Pugliese, M., Ramsay, T., Johnson, D., et al.[2018]

The STARFISH mobile app intervention significantly increased daily step counts by 39.3% in stroke survivors over six weeks, while the control group experienced a 20.2% decrease in steps, indicating its effectiveness in promoting physical activity.

The intervention also positively impacted walking time and reduced fatigue levels among participants, suggesting that STARFISH could enhance overall health outcomes for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in stroke survivors using STARFISH, an interactive mobile phone application: a pilot study. Paul, L., Wyke, S., Brewster, S., et al.[2022]

A qualitative study involving 12 stroke survivors revealed that participants found tablets easy to use and beneficial for engaging in therapeutic and leisure activities during the first three months of recovery.

The use of tablet technology was associated with increased participation in therapy, enhanced socialization, and reduced boredom, suggesting it could be a valuable tool in stroke rehabilitation, although further research is needed to assess its impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet technology during stroke recovery: a survivor's perspective. White, J., Janssen, H., Jordan, L., et al.[2016]

A systematic review of computer-based cognitive rehabilitation (CBCR) for working memory impairment after stroke found insufficient evidence to determine its effectiveness, as studies showed highly variable results and used different measures of working memory.

No harmful effects were reported from CBCR interventions, but the lack of meaningful differences in working memory improvement compared to control groups suggests that more research is needed to assess its true benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. Niemeijer, M., Sværke, KW., Christensen, HK.[2020]

A systematic review identified only six mobile health apps specifically aimed at supporting lifestyle changes after a transient ischaemic attack (TIA) or minor stroke, out of 2545 potential apps, indicating a significant gap in available resources for this population.

The overall quality of the apps was low, with a mean Mobile Application Rating Scale (MARS) score of 2.57 out of 5, and none of the apps were deemed to be of 'good' quality, highlighting the need for better-designed, evidence-based digital interventions for secondary prevention in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the quality and content of mobile apps to support lifestyle modifications following a transient ischaemic attack or 'minor' stroke. O'Connor, SR., Kee, F., Thompson, DR., et al.[2022]

A smartphone app designed for managing vascular risk factors significantly increased physical activity levels in younger stroke patients, with the intervention group reporting nearly double the activity compared to the control group after three months.

Patients using the app also experienced improvements in health-related quality of life and better management of smoking and hypertension, indicating that such digital interventions can effectively promote healthier lifestyles post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Newly Developed Smartphone App for Risk Factor Management in Young Patients With Ischemic Stroke: A Pilot Study. Fruhwirth, V., Berger, L., Gattringer, T., et al.[2023]

A scoping review identified 49 studies on mobile health (mHealth) apps designed to support adults living with the effects of stroke, showing a significant increase in research on this topic over the past two years.

Most studies focused on improving upper extremity function and medical management, but many were preliminary, indicating a need for further research and large-scale trials to validate the efficacy and usability of these apps for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Intervention Applications for Adults Living With the Effects of Stroke: A Scoping Review. Burns, SP., Terblanche, M., Perea, J., et al.[2022]

A structured, multidisciplinary intervention program for patients with first-ever stroke or transient ischemic attack (TIA) significantly reduced depressive symptoms one year post-stroke, with only 4.7% of patients in the intervention group experiencing depression compared to 13.5% in the control group.

The intervention also led to a statistically significant improvement in anxiety and depression scores, as measured by the Hospital Anxiety and Depression Scale (HADS), indicating that managing vascular risk factors can positively impact emotional well-being after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Ihle-Hansen, H., Thommessen, B., Fagerland, MW., et al.[2022]

A review identified 45 commercial mobile applications designed to assist in the assessment and treatment of stroke patients, categorized into various therapeutic functions such as exercise programs and mobility aids.

Only 10 of these apps have been validated through scientific studies, indicating that while there are useful tools available, the evidence supporting their efficacy is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Commercial mobile applications in the therapeutic approach to stroke: Review in main application repositories and scientific evidence]. Ortega-Martín, ME., Lucena-Antón, D., Luque-Moreno, C., et al.[2022]

In a study of 39 stroke survivors, computerized cognitive training (CCT) using Lumosity software led to significant improvements in global cognitive function and specific cognitive skills like verbal working memory and processing speed after 12 weeks of training.

While CCT showed immediate cognitive benefits that were maintained for 4 weeks, it did not significantly affect daily activities or participation, and no major differences were found when compared to conventional cognitive training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. Ho, HY., Chen, MD., Tsai, CC., et al.[2022]

Post-stroke depression (PSD) affects about one-third of stroke survivors and can worsen recovery by limiting rehabilitation participation and increasing the risk of future health issues, including higher mortality rates.

The article proposes an mHealth intervention called iMOODS to provide culturally tailored psychological care for PSD in Peru, where access to mental health services is limited, leveraging the rapid growth of digital technology to improve outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of mHealth in overcoming the occurrence of post-stroke depression. Miranda, JJ., Moscoso, MG., Toyama, M., et al.[2023]

Smartphone apps can significantly improve the management of risk factors like hypertension and diabetes in stroke patients, which is crucial for preventing recurrent strokes, based on a review of 10 studies.

Patients generally find these mobile health apps useful and are receptive to using them, as long as they complement traditional medical care rather than replace it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of smartphone apps in secondary stroke prevention]. Fruhwirth, V., Enzinger, C., Weiss, E., et al.[2020]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9872745/

Effect of mobile application types on stroke rehabilitation Mobile apps demonstrate potential to assist with stroke recovery and augment face to face rehabilitation, however, development of a mobile app ...

3. withpower.com withpower.com/trial/phase-anxiety-1-2025-18587

Mobile Cognitive Behavioral Therapy for Stroke Research suggests that mobile health technology, like apps, can help manage post-stroke depression and improve control of risk factors such as high blood ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.029042?doi=10.1161/STROKEAHA.120.029042

Telemedicine Cognitive Behavioral Therapy for Anxiety ... Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10763083/

Effectiveness of mobile application interventions for stroke ... Our study suggested that mobile application interventions may have a potential benefit to stroke survivors, but clinical effectiveness should be established.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214782920301068

A pilot randomized controlled clinical trial protocol This pilot RCT is the first study to investigate the potential of iPad application interventions to reduce depressive symptoms in PSD patients.