Mobile Cognitive Behavioral Therapy for Stroke

Mobile Cognitive Behavioral Therapy for Stroke

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.

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.

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