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NCT Number: NCT06782321

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mental Health Wellness 1 Nervous System Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Kelly Rishe, MSOT

CONTACT

[email protected]

843-985-1810

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)

    Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.

    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.

  2. Patient Specific Functional Scale (PSFS)

    Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.

    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.

  3. Stroke and Aphasia Quality of Life Scale (SAQoL)

    Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Finetto

CONTACT

[email protected]

843-792-8533

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • The Duke Endowment

Registry information

Official study title

Centering Emotional Recovery Post-Stroke

Acronym: eWELL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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