Mobile Cognitive Behavioral Therapy for Stroke

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Stroke; Depression; Anxiety

Treatments: Behavioral: Mobile Cognitive Behavioral App

Study type: Interventional

Funder types: Other

Identifiers

NCT06689878

24-04027396

Details and patient eligibility

About

This study aims to assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.

Full description

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. Feasibility will be measured by the total number of sessions completed and acceptability will be measured by scores on the Mobile Application Rating Scale-User Version (uMARS). Qualitative feedback will also be collected with a questionnaire using open-ended questions.

A secondary objective will be to evaluate preliminary efficacy of the mobile CBT application on symptoms of depression and anxiety assessed using (1) interview-based measures (the Montgomery Asberg Depression Rating Scale [MADRS] and the Hamilton Anxiety Rating Scale [HAM-A]), and (2) a patient reported outcome measure (the 21-item Depression, Anxiety, and Stress Scale [DASS]).

This study will collect pilot data over the course of 8 weeks. Because this is a pilot study, all participants will use the same version of the app and there will be no control group. Primary outcome measures will be collected at baseline (pre-intervention) and at the endpoint (week 8). Participants will be asked to use the mobile app for at least two days a week, for 30 minutes on each day, for 8 weeks. Participants will have weekly check-ins in person or via a HIPAA compliant virtual meeting platform (Zoom) with a study staff member to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40-79
• Presence of clinically-significant anxiety and/or depression (as determined by an eligibility evaluation)
• Stroke that occurred 1 month or more prior to study initiation
• Capacity to provide consent
• No greater than mild cognitive difficulties based on an eligibility evaluation conducted as part of the study
• If taking medication for depression and/or anxiety, must be on a stable dose for a minimum of 8 weeks prior to study initiation
• Ability to use iPhone or iPad independently
• Home internet access
• Willingness to participate in the full study duration.

Exclusion criteria

• Aphasia of moderate or greater severity (as determined during an eligibility evaluation)
• Non-fluency in English
• History of a bipolar or psychotic disorder
• Current alcohol or substance use disorder
• Active suicidal ideation
• Current engagement in psychotherapy is not grounds for exclusion unless the individual's psychotherapy is primarily focused on CBT
• Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the study doctor, which warrants a higher level of care and/or immediate referral to psychiatric services
• Any other clinical or medical reason in the study doctor's initial screening 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:

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.

Treatment:

Behavioral: Mobile Cognitive Behavioral App