Emotional Recovery Post-Stroke (eWELL)

Centering Emotional Recovery Post-Stroke

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Occupational or Speech Therapy; Behavioral: modified Cognitive Behavioral Therapy (mCBT)

Detailed Description

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Finetto; Phone Number: 843-792-8533; Email: piersonp@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Kelly Rishe, MSOT; Phone Number: 843-985-1810; Email: callahk@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
• Have experienced ischemic or hemorrhagic stroke at least 30 days prior
• Stroke-related aphasia and/or upper extremity hemiparesis
• Aged 21 years or older
• English as primary language
• Have corrected vision to be able to read text on a screen
• Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service
• Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist

Exclusion Criteria:

• Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
• Pain that interferes with ability to participate in the study's upper extremity movement tasks.
• Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy	Behavioral: Occupational or Speech Therapy; If the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation. The OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA). Telerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance/coaching from the therapist, and self-evaluation.; Behavioral: modified Cognitive Behavioral Therapy (mCBT); The theoretical model underling Cognitive Behavioral Therapy (CBT) explains the interaction of thoughts, feelings, and behaviors during life situations. This model suggests that a person's thoughts/feeling/behaviors affect their functioning during life situations. This contrasts with a common belief that one's functioning during life situations is the only way to effect thoughts/feelings/behaviors. Applied to stroke, this model suggests that the stroke survivor can alter his/her functioning during life situations by altering his/her thoughts/feelings/behaviors. The purpose of CBT is to empower the person with the skills to alter his/her thoughts/feelings/behaviors in order to positively affect function in life situations. The mCBT intervention includes 4 elements: psychoeducation, education about unhelpful thinking, behavioral activation therapy, education on sleep hygiene, and relaxation training.
Active Comparator: Telerehabilitation Occupational or Speech Therapy	Behavioral: Occupational or Speech Therapy; If the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation. The OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA). Telerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance/coaching from the therapist, and self-evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)	14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Patient Specific Functional Scale (PSFS)	A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Stroke and Aphasia Quality of Life Scale (SAQoL)	39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.	Baseline, pre-intervention and immediately after the intervention, Week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Specific Functional Scale (PSFS)	Patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.	Baseline, pre-intervention and immediately after the intervention, Week 8.
The Communication Participation Item Bank Short Form (CPIB-10)	10-item questionnaire in which the participant identifies the degree to which communication-related life activities (e.g., talking with strangers, communicating in a small group, having a long conversation with a friend) are impacted by aphasia. Each item is ranked on a 4-point scale (0=very much, 3=not at all). Summed item ratings are reported so that higher scores indicate greater functional communication skills.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Telerehabilitation-modified Fugl-Meyer Assessment of the Upper Extremity (tmFMA-UE)	15-item scale of arm/hand movements rated by the therapist (0=no motion, 2=normal). Summed item ratings are reported so that higher values indicate greater movement ability.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Performance Quality Rating Scale (PQRS)	The OT observes live performance (via the telerehabilitation video call) of one of the tasks not chosen on the PSFS. The subject's performance is rated by the OT on a 0-10-point ordinal scale with higher ratings indicating greater task performance skill.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Revised Western Aphasia Battery (WAB-R)	32-item test of linguistic and non-linguistic skills across 8 subscales. Its score is used to classify the type and severity of aphasia disorder and gives clinically valid data documenting treatment effect.	Baseline, pre-intervention and immediately after the intervention, Week 8.
Stroke Self Efficacy Questionnaire (SSEQ)	13-item patient self-report of their confidence (0-10-point Likert scale with higher numbers indicating greater confidence) doing at-home tasks such as using both hands to eat food or prepare a meal for oneself.	Baseline, pre-intervention and immediately after the intervention, Week 8.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: The Duke Endowment
• Investigators: Principal Investigator: Lisa McTeague, PhD, Medical University of South Carolina; Principal Investigator: Michelle Woodbury, PhD, Medical University of South Carolina; Principal Investigator: Deena Blackett, PhD, University of Central Florida

Publications and helpful links

General Publications

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
• Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.
• McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.
• Ayerbe L, Ayis SA, Crichton S, Wolfe CD, Rudd AG. Natural history, predictors and associated outcomes of anxiety up to 10 years after stroke: the South London Stroke Register. Age Ageing. 2014 Jul;43(4):542-7. doi: 10.1093/ageing/aft208. Epub 2013 Dec 26.
• Bhattacharjee S, Axon DR, Goldstone L, Lee JK. Patterns and Predictors of Depression Treatment among Stroke Survivors with Depression in Ambulatory Settings in the United States. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):563-567. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.047. Epub 2017 Oct 31.
• Kowalska K, Krzywoszanski L, Dros J, Pasinska P, Wilk A, Klimkowicz-Mrowiec A. Early Depression Independently of Other Neuropsychiatric Conditions, Influences Disability and Mortality after Stroke (Research Study-Part of PROPOLIS Study). Biomedicines. 2020 Nov 17;8(11):509. doi: 10.3390/biomedicines8110509.
• Skolarus LE, Lisabeth LD, Burke JF, Levine DA, Morgenstern LB, Williams LS, Pfeiffer PN, Brown DL. Racial and Ethnic Differences in Mental Distress among Stroke Survivors. Ethn Dis. 2015 Spring;25(2):138-44.
• HRSA. Behavioral Health Workforce, 2023. In: HRSA, editor.: National Center for Health Workforce Analysis; 2023.
• Services UDoHaH. South Carolina Mental Health Health Professional Shortage Areas (HPSA): GIS Office of Information Technology; 2023 [updated 03-07-2023]. Available from: https://scdhec.gov/sites/default/files/media/document/HPSA-Mental-Health-2023.pdf.
• Hamilton RKB, Phelan CH, Chin NA, Wyman MF, Lambrou N, Cobb N, Kind AJH, Blazel H, Asthana S, Gleason CE. The U-ARE Protocol: A Pragmatic Approach to Decisional Capacity Assessment for Clinical Research. J Alzheimers Dis. 2020;73(2):431-442. doi: 10.3233/JAD-190457.
• Paolucci S, Iosa M, Coiro P, Venturiero V, Savo A, De Angelis D, Morone G. Post-stroke Depression Increases Disability More Than 15% in Ischemic Stroke Survivors: A Case-Control Study. Front Neurol. 2019 Aug 27;10:926. doi: 10.3389/fneur.2019.00926. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Stroke Recovery; Rehabilitation Studies
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Speech Therapy
• Other Study ID Numbers: Pro00138136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No