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Behavioral Intervention

Mobile Cognitive Behavioral Therapy for Stroke

N/A

Waitlist Available

Led By Abhishek Jaywant, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to provide consent

Age 40-79

Must not have

Non-fluency in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, and week 8 of treatment (8 week treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a mobile app called "MAYA" that provides therapy for anxiety and mood disorders in adults who have had a stroke to see if it is practical and well-liked by the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves using a mobile app for therapy rather than medication, traditional side effects like those seen with drugs aren't expected. However, users may experience discomfort or emotional distress when confronting difficult emotions during CBT exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 40 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, and week 8 of treatment (8 week treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, and week 8 of treatment (8 week treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, and week 8 of treatment (8 week treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)

Number of Sessions completed over study time period

Qualitative Interview

Secondary study objectives

Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A)

Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)

Change in depression, anxiety, and stress, as measured by the Depression, Anxiety, and Stress Scale (DASS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention Arm Using the Mobile Cognitive Behavioral Therapy AppExperimental Treatment1 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.

0 / 3Eligibility criteria met