Clinical trial NCT06689878: Mobile Cognitive Behavioral Therapy for Stroke
Official title: Mobile Cognitive Behavioral Therapy for Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Stroke
Depression
Keywords: stroke recovery
stroke rehabilitation
cognitive behavioral therapy
CBT
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
timeFrame: Week 4 of treatment
measure: Feasibility and Acceptability of MAYA as measured by the Mobile Application Rating Scale-User Version (uMARS)
timeFrame: Week 8 of treatment
measure: Number of Sessions completed over study time period
timeFrame: Week 1 to Week 8 (8 week treatment)
measure: Qualitative Interview
timeFrame: Week 8 of treatment
Secondary outcomes:
measure: Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
measure: Change in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
measure: Change in depression, anxiety, and stress, as measured by the Depression, Anxiety, and Stress Scale (DASS)
timeFrame: Baseline, Week 4, and Week 8 of treatment (8 week treatment)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Abhishek Jaywant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.