Mobile Cognitive Behavioral Therapy for Stroke

Overview

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.

Interventions

• Device Mobile CBT for Stroke
  A mobile cognitive behavioral therapy (CBT) app called "Maya" that includes modules with educational content and teaching and practice of strategies that address depression and anxiety after stroke.

Primary outcome measures

• Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS) [Time frame: Week 4 of treatment]
• Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS) [Time frame: Week 8 of treatment]
• Number of Sessions completed over study time period [Time frame: Week 1 to Week 8 (8 week treatment)]
• Qualitative Interview [Time frame: Week 8 of treatment]

Secondary outcome measures (3)

• Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) [Time frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)]
• Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A) [Time frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)]
• Change in depression, anxiety, and stress, as measured by the Depression, Anxiety, and Stress Scale (DASS) [Time frame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Weill Cornell Medicine — New York

Publications

• Wilhelm S, Weingarden H, Ladis I, Braddick V, Shin J, Jacobson NC. Cognitive-Behavioral Therapy in the Digital Age: Presidential Address. Behav Ther. 2020 Jan;51(1):1-14. doi: 10.1016/j.beth.2019.08.001. Epub 2019 Aug 8. PMID 32005328
• Wang SB, Wang YY, Zhang QE, Wu SL, Ng CH, Ungvari GS, Chen L, Wang CX, Jia FJ, Xiang YT. Cognitive behavioral therapy for post-stroke depression: A meta-analysis. J Affect Disord. 2018 Aug 1;235:589-596. doi: 10.1016/j.jad.2018.04.011. Epub 2018 Apr 5. PMID 29704854
• Wada Y, Otaka Y, Yoshida T, Takekoshi K, Takenaka R, Senju Y, Maeda H, Shibata S, Kishi T, Hirano S. Effect of Post-stroke Depression on Functional Outcomes of Patients With Stroke in the Rehabilitation Ward: A Retrospective Cohort Study. Arch Rehabil Res Clin Transl. 2023 Aug 2;5(4):100287. doi: 10.1016/j.arrct.2023.100287. eCollection 2023 Dec. PMID 38163038
• Bress JN, Falk A, Schier MM, Jaywant A, Moroney E, Dargis M, Bennett SM, Scult MA, Volpp KG, Asch DA, Balachandran M, Perlis RH, Lee FS, Gunning FM. Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428372. doi: 10.1001/jamanetworkopen.2024.28372. PMID 39163044
• Mitchell AJ, Sheth B, Gill J, Yadegarfar M, Stubbs B, Yadegarfar M, Meader N. Prevalence and predictors of post-stroke mood disorders: A meta-analysis and meta-regression of depression, anxiety and adjustment disorder. Gen Hosp Psychiatry. 2017 Jul;47:48-60. doi: 10.1016/j.genhosppsych.2017.04.001. Epub 2017 Apr 3. PMID 28807138
• Ahrens J, Shao R, Blackport D, Macaluso S, Viana R, Teasell R, Mehta S. Cognitive -behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2023 May;30(4):368-383. doi: 10.1080/10749357.2022.2049505. Epub 2022 Mar 30. PMID 35352629

Identifiers

NCT: NCT06689878 · 24-04027396

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗