Emotional Recovery Post-Stroke

NCT06782321 | Recruiting

• 1 other identifier: Pro00138136
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Mental Health Wellness 1

Keywords

Rehabilitation Studies; Stroke; Stroke Recovery

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy

EXPERIMENTAL

Behavioral: modified Cognitive Behavioral Therapy (mCBT); Behavioral: Occupational or Speech Therapy

Telerehabilitation Occupational or Speech Therapy

ACTIVE COMPARATOR

Behavioral: Occupational or Speech Therapy

Interventions

modified Cognitive Behavioral Therapy (mCBT) BEHAVIORAL

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.

modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy

Occupational or Speech Therapy BEHAVIORAL

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.

Telerehabilitation Occupational or Speech Therapy; modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• The Duke Endowment: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 24375225 BACKGROUND

• 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.

  PMID: 25117911 BACKGROUND

• 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.

  PMID: 29097059 BACKGROUND

• Harrison RA. A simple pattern for Plastazote boots. Physiotherapy. 1984 Mar;70(3):114-5. No abstract available.

  PMID: 6718567 BACKGROUND

• 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.

  PMID: 33213019 BACKGROUND

• 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.

  PMID: 21441153 BACKGROUND

• 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.

  PMID: 26118139 BACKGROUND

• HRSA. Behavioral Health Workforce, 2023. In: HRSA, editor.: National Center for Health Workforce Analysis; 2023.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31868663 BACKGROUND

• 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.

  PMID: 18042300 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Michelle Woodbury, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Lisa McTeague, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Deena Blackett, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Rishe

CONTACT

843-985-1810; callahk@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: Randomized rehabilitation clinical trial with adaptive design. At study midpoint, a preliminary analysis will identify the intervention showing the greatest effect on the majority of the primary outcome measures. Subsequently, the randomization ratio will be adapted to 2:1 in favor of that intervention

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)