Mobile Cognitive Behavioral Therapy in Early Stroke Recovery

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

Conditions: Stroke; Anxiety; Depression - Major Depressive Disorder

Treatments: Device: Mobile Cognitive Behavioral Therapy App

Study type: Interventional

Funder types: Other

Identifiers

NCT07639606

26-01029701

Details and patient eligibility

About

This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.

Full description

The focus of the present study is neuropsychiatric symptoms (i.e., depression, apathy, and anxiety) in individuals who experienced a stroke. Post-stroke neuropsychiatric symptoms are highly prevalent and are associated with diminished quality of life, caregiver distress, and poorer functional capacity and stroke recovery.

The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) application. The app includes modules with educational content and practice of strategies that address the following: (1) education about mood symptoms post-stroke and their association with recovery/rehabilitation; (2) mindfulness, relaxation, and distress tolerance skills; (3) increasing awareness of thinking errors and reframing negative thoughts; and (4) self-compassion, gratitude, and ways to promote resilience during stroke recovery and rehabilitation. The app includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. For the current study, app language and examples will be adapted for individuals with stroke. Participants will be asked to use the app for 3 days per week over a 5-week period, for ~20 minutes in each use.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-79
• Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score >= 8) and/or HADS-A (anxiety, score >= 8).
• Stroke that occurred within 1 month prior to study initiation.
• Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)
• Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties
• Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)
• Able to adhere to all study requirements and willingness to participate in the full study duration

Exclusion criteria

• Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care
• Non-fluency in English
• History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)
• Active suicidal ideation requiring a higher level of care
• Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services
• Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention Arm Using the Mobile Cognitive Behavioral Therapy App

Experimental group

Description:

The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) mobile application. The app includes modules with educational content and practice of strategies that address post-stroke depression, anxiety, and emotional difficulties.

Treatment:

Device: Mobile Cognitive Behavioral Therapy App