NCT06689878NARecruiting

Mobile Cognitive Behavioral Therapy for Stroke

Weill Medical College of Cornell University

Start Date

2/25/2025

Completion Date

3/1/2028

Summary

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.

Detailed 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.

Eligibility Criteria

Age Range: 40 years to 79 years

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

Interventions

BEHAVIORAL

Mobile Cognitive Behavioral App

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Conditions

AnxietyStrokeDepression

Locations

Weill Cornell Medicine

New York, New York 10065

United States