Mobile Cognitive Behavioral Therapy in Early Stroke Recovery

Обзор

This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.

Подробное описание

The focus of the present study is neuropsychiatric symptoms (i.e., depression, apathy, and anxiety) in individuals who experienced a stroke. Post-stroke neuropsychiatric symptoms are highly prevalent and are associated with diminished quality of life, caregiver distress, and poorer functional capacity and stroke recovery.

The intervention used in the present study is an adapted version of Maya, a cognitive behavioral therapy (CBT) application. The app includes modules with educational content and practice of strategies that address the following: (1) education about mood symptoms post-stroke and their association with recovery/rehabilitation; (2) mindfulness, relaxation, and distress tolerance skills; (3) increasing awareness of thinking errors and reframing negative thoughts; and (4) self-compassion, gratitude, and ways to promote resilience during stroke recovery and rehabilitation. The app includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. For the current study, app language and examples will be adapted for individuals with stroke. Participants will be asked to use the app for 3 days per week over a 5-week period, for \~20 minutes in each use.

Вмешательства

• Устройство Mobile Cognitive Behavioral Therapy App
  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.

Первичные конечные точки

• Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) [Срок оценки: Week 5 of treatment]
• Percent of Sessions completed over study time period [Срок оценки: From Week 1 to Week 5 of treatment]
• Percent of homework exercises completed [Срок оценки: From Week 1 to Week 5 of treatment]

Вторичные конечные точки (4)

• Mean change from baseline to week 3 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, Week 3]
• Mean change from baseline to week 5 in depression and anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, Week 5]
• Mean change from baseline to week 3 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE) [Срок оценки: Baseline, Week 3]
• Mean change from baseline to week 5 in coping self-efficacy as measured by the PROMIS Self-Efficacy for Managing Chronic conditions-Managing Emotions 8-item questionnaire (PROMIS-SE) [Срок оценки: Baseline, Week 5]

Критерии участия

Критерии включения

• Age 18-79
• Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score >= 8) and/or HADS-A (anxiety, score >= 8).
• Stroke that occurred within 1 month prior to study initiation.
• Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)
• Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties
• Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)
• Able to adhere to all study requirements and willingness to participate in the full study duration

Критерии исключения

• Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care
• Non-fluency in English
• History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)
• Active suicidal ideation requiring a higher level of care
• Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services
• Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Публикации

• Caeiro L, Ferro JM, Figueira ML. Apathy in acute stroke patients. Eur J Neurol. 2012 Feb;19(2):291-7. doi: 10.1111/j.1468-1331.2011.03508.x. Epub 2011 Sep 6. PMID 21895880
• Minshall C, Castle DJ, Thompson DR, Pascoe M, Cameron J, McCabe M, Apputhurai P, Knowles SR, Jenkins Z, Ski CF. A psychosocial intervention for stroke survivors and carers: 12-month outcomes of a randomized controlled trial. Top Stroke Rehabil. 2020 Dec;27(8):563-576. doi: 10.1080/10749357.2020.1738677. Epub 2020 Mar 19. PMID 32191569
• Lapadatu I, Morris R. The relationship between stroke survivors' perceived identity and mood, self-esteem and quality of life. Neuropsychol Rehabil. 2019 Mar;29(2):199-213. doi: 10.1080/09602011.2016.1272468. Epub 2017 Jan 11. PMID 28075218
• 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
• Schottke H, Giabbiconi CM. Post-stroke depression and post-stroke anxiety: prevalence and predictors. Int Psychogeriatr. 2015 Nov;27(11):1805-12. doi: 10.1017/S1041610215000988. Epub 2015 Jul 16. PMID 26178418
• Medeiros GC, Roy D, Kontos N, Beach SR. Post-stroke depression: A 2020 updated review. Gen Hosp Psychiatry. 2020 Sep-Oct;66:70-80. doi: 10.1016/j.genhosppsych.2020.06.011. Epub 2020 Jun 27. PMID 32717644

Идентификаторы

NCT: NCT07639606 · 26-01029701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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