mobile cognitive behavioral therapy for stroke

Conditions: Anxiety; Stroke; Depression

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.

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:
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

Keywords: stroke recovery stroke rehabilitation cognitive behavioral therapy cbt