Emotional Recovery Post-Stroke

NCT06782321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-23

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782321 on ClinicalTrials.gov