Emotional Recovery Post-Stroke
NCT06782321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-05-23
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
The Duke Endowment
collaborator OTHER -
Medical University of South Carolina
lead OTHER
Principal Investigators
-
Michelle Woodbury, PhD · Medical University of South Carolina
-
Lisa McTeague, PhD · Medical University of South Carolina
-
Deena Blackett, PhD · University of Central Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- United States
Study Locations
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